ASTRAZENECA PLC Clinical trials appendix
Full year and Q4 2020 results update
Movement since Q3 2020 update
New to Phase I | New to Phase II | New to Pivotal trial | New to registration |
NME AZD3366 CD39L3 CV disease AZD3427 Relaxin ThP CV disease AZD5305 PARP1Sel solid tumours MEDI5752 + Axitinib PD-1/CTLA-4 bispecific mAb + VEGF advanced renal cell carcinoma MEDI9253 rNDV IL12 solid tumor | NME AZD8233 hypercholesterolemia CV disease MEDI6570 LOX-1 mAb CV disease Imfinzi + imaradenant# (AZD4635) + cabazitaxel PD-L1 mAb + A2aR inhibitor + chemotherapy prostate cancer Additional indication adavosertib# Wee1 inhibitor uterine serous cancer AZD5718 FLAP CKD Lifecycle Management Enhertu# DESTINY-PanTumour01 HER2 targeting antibody drug conjugate HER2-expressing solid tumors Fasenra ARROYO IL-5R mAb atopic dermatitis Fasenra HILLIER IL-5R mAb chronic spontaneous urticaria | NME AZD7442 COVID-19 long-acting antibody combination prevention and treatment of COVID-19 monalizumab# + cetuximab (INTERLINK-1) NKG2a mAb + EGFR mAb 2L+ relapsed metastatic head and neck squamous cell cancer Lifecycle Management Breztri LABA/LAMA/ICS asthma Enhertu# DESTINY-Breast05 HER2 targeting antibody drug conjugate HER2-positive post-neoadjuvant high-risk breast cancer Farxiga/Forxiga2 DAPA-MI SGLT2 inhibitor prevention of heart failure and CV death following a myocardial infarction in patients without type-2 diabetes Imfinzi# + CRT KUNLUN PD-L1 mAb + CRT locally advanced esophageal squamous cell carcinoma Imfinzi# + CTx MATTERHORN PD-L1 mAb + CTx neoadjuvant/adjuvant gastric cancer Tagrisso +/- CTx neoadjuvant NeoADAURA EGFR inhibitor +/- CTx stage II/III resectable EGFRm NSCLC | NME COVID-19 Vaccine AstraZeneca [EU] 1 SARS-CoV-2 COVID vaccine Lifecycle Management Farxiga/Forxiga2 Dapa-CKD [US, EU, JP & CN] 1 SGLT2 inhibitor renal outcomes and CV mortality in patients with CKD |
Phase progressions based on first patient dose achievement.
¶ Registrational Phase II/III trial # Partnered and/or in collaboration 1 Submission accepted
2 Farxiga in the US; Forxiga in ROW
Movement since Q3 2020 update
Removed from Phase I | Removed from Phase II | Removed from Phase III | Removed from registration |
NME AZD5153 BRD4 inhibitor solid tumours, haematological malignancies AZD5634 inhaled ENaC cystic fibrosis AZD6615 hypercholesterolemia CV disease AZD9496 selective oestrogen, oestrogen receptor +ve breast cancer | NME abediterol# LABA asthma / COPD imaradenant# (AZD4635) A2aR inhibitor prostate cancer oleclumab + imaradenant# (AZD4635) CD73 mAb + A2aR inhibitor prostate cancer velsecorat inhaled SGRM asthma / COPD Lifecycle Management Calquence CALAVI BTK inhibitor COVID-19 | Additional indication Imfinzi# + tremelimumab KESTREL PD-L1 mAb + CTLA-4 mAb 1st-line HNSCC Lifecycle Management Farxiga/Forxiga2 DETERMINE-Preserved SGLT-2 inhibitor heart failure with preserved ejection fraction Farxiga/Forxiga2 DETERMINE-Reduced SGLT-2 inhibitor heart failure with reduced ejection fraction | NME COVID-19 Vaccine AstraZeneca# [EU] 1 SARS-CoV-2 COVID vaccine Lifecycle Management Brilinta3 THALES [US] 1 P2Y12 receptor antagonist acute ischaemic stroke or transient ischaemic attack Symbicort SYGMA [CN] 1 ICS/LABA as-needed use in mild asthma Tagrisso ADAURA [US] 1 EGFR inhibitor adjuvant EGFRm NSCLC |
Phase progressions based on first patient dose achievement.
¶ Registrational Phase II/III trial # Partnered and/or in collaboration 1 Approved
2 Farxiga in the US; Forxiga in ROW 3 Brilinta in the US and Japan; Brilique in ROW
Q4 2020 new molecular entity (NME)1 pipeline
Phase I
21 New Molecular Entities
AZD0466
BCL2/xL haematological and solid tumours
AZD1390 glioblastomaAZD4573
CDK9 haematological malignanciesAZD5305
PARP1Sel solid tumoursAZD5991
MCL1 haematological malignanciesAZD7648#
DNAPK solid and haematological tumours
AZD8701
FOXP3 solid tumoursCalquence (platform) PRISM
BTK + multiple novel onc therapies r/r aggressive NHLCalquence+ceralasertib BTK+ATR haematological tumoursImfinzi#+adavosertib# PD-L1+Wee1 solid tumoursImfinzi#+tremelimumab PD-L1+CTLA-4 solid tumoursImfinzi#+tremelimumab+chemo PD-L1+CTLA-4 1L PDAC oesophageal SCLC
Imfinzi+selumetinib# PD-L1+MEK solid tumoursIPH5201#
CD39 solid tumoursMEDI1191
IL12 mRNA solid tumoursMEDI2228
BCMA ADC multiple myelomaMEDI5395 rNDV GMCSF solid tumoursMEDI5752+Axitinib PD-1/CTLA-4+VEGF advanced renal cell carcinoma
MEDI9253 rNDV IL12 solid tumoursTagrisso combo# TATTON EGFR+MEK/MET advanced EGFRm NSCLC
Phase II
21 New Molecular Entities
adavosertib#
Wee1 ovarian / uterine serous / solid tumours
AZD2811 nanoparticle
Aurora solid tumours, haematological malignancies
camizestrant (AZD9833) SERD ER+ breastcapivasertib# AKT prostateImfinzi (platform) HUDSON PD-L1+multiple novel ONC therapies post IO NSCLC
Imfinzi# (platform) BALTIC PD-L1+CTLA-4, WEE1+Carboplatin, ATR+PARP ES-SCLC R/R
Imfinzi# (platform) COAST PD-L1+multiple novel ONC therapies NSCLC
Imfinzi# (platform) NeoCOAST PD-L1+multiple novel ONC therapies NSCLC
Imfinzi# + imaradenant# (AZD4635) + cabazitaxel
PD-L1+A2aR+CTx prostate cancerImfinzi#+Lynparza# ORION PD-L1+PARP 1L mNSCLC
1 Includes novel combinations and additional indications for assets where the lead is not yet launched. # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial
Imfinzi#+monalizumab# PD-L1+NKG2a solid tumoursImfinzi#+tremelimumab
PD-L1+CTLA-4 biliary tract oesophagealImfinzi#+tremelimumab PD-L1+CTLA-4 gastric cancerImfinzi+FOLFOX+bevacizumab (platform) COLUMBIA1 PD-L1+chemo+VEGF+multiple novelImfinzi+Lynparza# BAYOU PD-L1+PARP bladderLynparza#+AZD6738 VIOLETTE PARP+ATR breast
MEDI5752
PD-1/CTLA-4 solid tumoursoleclumab+chemo or Imfinzi#+ oleclumab+chemo CD73+chemo or PD-L1+CD73+chemo pancreatic
Post-1L Tagrisso (platform) ORCHARDEGFR+multiple novel ONC therapies EGFRm NSCLC
Tagrisso+savolitinib# SAVANNAH EGFR+MET advanced EGFRm NSCLC
Phase III
10 New Molecular Entities
capivasertib# + abiraterone CAPItello-281AKT+abiraterone PTEN deficient metastatic hormone sensitive prostate cancer
capivasertib#+fulvestrant CAPItello-291 AKT+fulvestrant locally-advanced (inoperable) or metastatic breast cancercapivasertib+chemotherapy CAPItello-290AKT+chemotherapy mTNBC 1LImfinzi#+/-tremelimumab+chemo POSEIDON PD-L1+/-CTLA-4+SoC 1L NSCLCImfinzi#+/-tremelimumab+CRT ADRIATICPD-L1+/-CTLA-4+CRT LS-SCLCImfinzi#+tremelimumab HIMALAYA PD-L1+CTLA-4 1L HCCImfinzi#+tremelimumab+SoC NILE PD-L1+CTLA-4+SoC 1L urothelial cancerLynparza#+Imfinzi# DUO-E PARP+PD-L1 1L endometrial cancerLynparza#+Imfinzi#+bevacizumab DUO-OPARP+PD-L1+VEGF 1L ovarian cancermonalizumab#+cetuximab INTERLINK-1 NKG2a+EGFR 2L+ relapsed metastatic HNSCC
Under Review
0 New Molecular Entities
Q4 2020 new molecular entity (NME)1 pipeline
Phase I
14 New Molecular Entities
AZD0284
RORg psoriasis / respiratoryAZD0449
Inhaled JAK inhibitor asthmaAZD1402# inhaled IL-4Ra asthmaAZD2373
Podocyte health nephropathyAZD2693 nonalcoholic steatohepatitisAZD3366
CD39L3 CV diseaseAZD3427
Relaxin ThP CV diseaseAZD4041# orexin 1 receptor antagonist opioid use disorder
AZD8154
Inhaled PI3Kgd asthmaAZD9977
MCR CV diseaseMEDI0618#
PAR2 antagonist mAb osteooarthritis pain
MEDI1341# alpha synuclein parkinson's diseaseMEDI1814# amyloidβ alzheimer's diseaseMEDI8367 avb8 chronic kidney disease
Phase II
21 New Molecular Entities
anifrolumab#
Type I IFN receptor lupus nephritisanifrolumab#
Type I IFN receptor SLE SCAZD4831 MPO HFpEFAZD5718
FLAP coronary artery disease / CKDAZD7986# DPP1 COPDAZD8233 hypercholesterolemia cardiovascularAZD8601#
VEGF-A cardiovascularAZD9567
SGRM chronic inflammatory diseasesbrazikumab
IL23 ulcerative colitiscotadutide
GLP-1/glucagon T2D / obesity / NASH / DKD
1 Includes novel combinations and additional indications for assets where the lead is not yet launched # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial
MEDI3506
IL-33 AD / COPD / asthma / COVID-19
MEDI5884# cholesterol modulation cardiovascularMEDI6012
LCAT cardiovascularMEDI6570
LOX-1 CV diseaseMEDI7352
NGF/TNF OA pain / painful diabetic neuropathy
navafenterol# MABA COPDsuvratoxumab α-Toxin Staphylococcus pneumoniatezepelumab#
TSLP atopic dermatitistezepelumab# TSLP COPDverinurad
URAT-1 CKD / HFpEF
Phase III
5 New Molecular Entities
AZD7442 long-acting antibody combination COVID-19
brazikumab¶
IL23 crohns diseasenirsevimab#
RSV mAb-YTE passive RSV immunisation
PT027 ICS/SABA asthmatezepelumab# NAVIGATOR SOURCE TSLP severe uncontrolled asthma
Under review
1 New Molecular Entity
anifrolumab# TULIP Type I IFN receptor SLE
Q4 2020 lifecycle management (LCM)1 pipeline
Phase I
1 Project
Imfinzi#+azacitidine# PD-L1+azacitidine MDS
Phase II
8 Projects
Enhertu# DESTINY-CRC-01 ADC colorectal cancerEnhertu# DESTINY-Gastric02 ADC gastric
Enhertu# DESTINY-Lung01 ADC NSCLC
Enhertu# DESTINY-PanTumor01 HER2 targeting ADC HER2-expressing solid tumours
Enhertu# DESTINY-PanTumor02 HER2 targeting ADC HER2-expressing solid tumours
Imfinzi# (platform) BEGONIA PD-L1 1L mTNBC
Imfinzi# (platform) MAGELLAN PD-L1 1L mNSCLCLynparza# (basket) MK-7339-002 / LYNK002
PARP HRRm cancer
Phase III
30 Projects
Calquence#
BTK inhibitor 1st line MCL
Calquence#
BTK inhibitor r/r CLL, high riskCalquence#+venetoclax+obinutuzumab BTK+BCL-2+anti-CD20 1st line CLLCalquence+R-CHOP ESCALADE BTK+R-CHOP 1L DLBCLEnhertu# DESTINY-Breast02 ADC breast
Enhertu# DESTINY-Breast03 ADC breast
Enhertu# DESTINY-Breast04 ADC breast
Enhertu# DESTINY-Breast05 ADC breast
Enhertu# DESTINY-Breast06 ADC breast
Imfinzi# + FLOT MATTERHORN PD-L1+CTx neo-adjuvant/adjuvant gastic
Imfinzi# CALLA
PD-L1 adj. locally-advanced cervical cancer
Imfinzi# PEARL
PD-L1 1L metastatic NSCLCImfinzi# post-SBRT PACIFIC-4 PD-L1 post-SBRT stage I/II NSCLCImfinzi# POTOMAC
PD-L1 non muscle invasive bladder cancerImfinzi#+CRT KUNLUN
PD-L1+CRT locally-advanced esophageal squamous cell carcinoma
Imfinzi#+CRT PACIFIC-2 PD-L1+CRT NSCLCImfinzi#+CRT PACIFIC-5 (China) PD-L1+CRT locally-advanced stage III NSCLC
Imfinzi#+Ctx MERMAID-1
PD-L1 stage II-III adjuvant NSCLCImfinzi#+CTx neoadjuvant AEGEAN PD-L1+CTx locally-advanced stage II-III NSCLC
Imfinzi#+CTx NIAGARA
PD-L1+CTx muscle invasive bladder cancerImfinzi#+CTx TOPAZ-1 PD-L1+CTx 1L biliary tract cancerImfinzi#+VEGF EMERALD-2 PD-L1+VEGF adjuvant HCCImfinzi#+VEGF+TACE EMERALD-1 PD-L1+VEGF+TACE locoregional HCCLynparza# LYNK-003
PARP platinum sensitive 1L colorectal cancer
Lynparza# OlympiA
PARP gBRCA adjuvant breast
Lynparza# SOLO-3
PARP BRCAm PSR ovarianLynparza+abiraterone# PROpel PARP+NHA prostate cancerTagrisso +/- CTx neoadjuvant NeoADAURA EGFR stage II/III resectable EGFRm NSCLC
Tagrisso LAURA
EGFRm locally-advanced unresectable NSCLC
Tagrisso+chemo FLAURA2 EGFR+chemo 1L adv EGFRm NSCLC
Under Review
0 Projects
Q4 2020 lifecycle management (LCM)1 pipeline
Phase I
0 Projects
Phase II
3 Projects
Fasenra ARROYO
IL-5R chronic spontaneous urticariaFasenra HILLIER IL-5R atopic dermatitisroxadustat#
HIF-PH inhibitor chemo induced anaemia
Phase III
9 Projects
Breztri
LABA/LAMA/ICS asthma
Farxiga/Forxiga DAPA-MI
SGLT2 prevention of HF and CV death following a myocardial infarction
Farxiga/Forxiga DELIVER SGLT2 HFpEF
Under Review
1 Project
Farxiga/Forxiga DAPA-CKD SGLT2 CKD
Estimated key regulatory submission acceptances
NMELCM
Calquence r/r CLL, high risk
ELEVATE-RR Imfinzi + CRT NSCLC
PACIFIC-2
COVID-19 Vaccine AstraZeneca
SARS-CoV-2 (US / Japan)
Fasenra nasal polyps
OSTRO
Note. NME section includes novel
Enhertu DESTINY-Breast02
DESTINY-Breast04 Imfinzi + CTx biliary tract
Imfinzi + VEGF + TACE locoregional HCC
EMERALD-1
Lynparza ovarian
SOLO-3
Duaklir Genuair COPD (China)
Xigduo XR/Xigduo type-2 diabetes (China)
assets where the lead is not yet launchedOncologyBioPharmaceuticals
Calquence + R-CHOP 1L DLBCL
ESCALADE
Enhertu
Calquence + venetoclax + obinutuzumab 1L CLL AMPLIFY
Calquence 1L MCL
TOPAZ-1
ECHO
Enhertu DESTINY-Breast05
Enhertu
DESTINY-Breast06 Imfinzi + CRT LA ESCC
KUNLUN
Imfinzi + CRT neo-adjuvant/adjuvant gastric
MATTERHORN
Imfinzi + CTx stage II-III adjuvant NSCLC
MERMAID-1
Imfinzi + VEGF adjuvant HCC
EMERALD-2
Imfinzi post-SBRT NSCLC
PACIFIC-4
Imfinzi cervical
CALLA
Imfinzi adjuvant NSCLC
BR.31
Imfinzi non muscle invasive bladder POTOMAC
Lynparza platinum sensitive 1L colorectal
LYNK-003 monalizumab + cetuximab 2L+ relapsed metastatic
HNSCC INTERLINK-1
Tagrisso stage II/III resectable EGFRm NSCLC
NeoADAURA
Tagrisso locally adv. unresectable NSCLC LAURA
Tagrisso + CTx EGFRm NSCLC
FLAURA2
Farxiga prevention of HF and CV death following a myocardial infarction DAPA-MI
Fasenra COPD
RESOLUTE
Fasenra eosinophilic esophagitis
MESSINA
Fasenra EGPA
MANDARA
Fasenra HES
NATRON
Fasenra nasal polyps ORCHID (China / Japan)
Designations
ACCELERATED APPROVAL, these regulations allowed medicines for serious conditions that addressed an unmet medical need to be approved based on a surrogate endpoint.
5 | 17 | 12 | 36 | 29 |
Accelerated approvals | Breakthrough / PRIME1 / Sakigake2 | Fast Track | Priority Review / RTOR3 | Orphan |
Lynparza ovarian cancer SOLO-2 (US) | Tagrisso EGFRm T790M NSCLC (US) | MEDI3902 Psl-PcrV pneumo Px (US) | Tagrisso EGFRm T790M NSCLC (JP) | |
Tagrisso EGFRm T790M NSCLC (US) | Lynparza prostate cancer PROFOUND (US) | savratoxumab Staph HAP (US) | Tagrisso EGFRm T790M NSCLC (US) |
tezepelumab asthma (US)nirsevimab RSV mAB (US)nirsevimab RSV mAB (EU)1
Imfinzi bladder cancer (US) Calquence MCL (US)
Enhertu unresectable or HER2+ MBC 3L DESTINY-Breast01 (US)
Imfinzi stage III NSCLC PACIFIC (JP)
selumetinib NFI type 1 SPRINT (US) Enhertu DESINTY-BREAST01 (US) Calquence CLL (US)
Lynparza tablet (US)
Lynparza tablet (CN)
Tagrisso NSCLC 1L FLAURA (JP)
Lumoxiti HCL PLAIT (US)
Lynparza ovarian SOLO-1 (US)
Lynparza ovarian SOLO-1 (CN)
Lynparza breast cancer OLYMPIAD (JP)
Calquence MCL (US) Calquence WM (US) Calquence CLL 1L (EU)
selumetinib thyroid cancer ASTRA (US) Lynparza breast cancer OLYMPIAD (JP) Lynparza ovarian cancer SOLO-2 (JP) Koselugo/ selumetinib NFI type 1 SPRINT (US) Koselugo/ selumetinib NFI type 1 SPRINT (EU)
Farxiga HF DAPA-HF (US)
Imfinzi +treme HCC 1L HIMALAYA (US)
BREAKTHROUGH DESIGNATION is a process designed to expedite the development and review of medicines which may demonstrate substantial improvement over available therapy. 1PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need. 2SAKIGAKE is aimed at early introduction of innovative medicines, medical devices, etc. that are initially developed in Japan.
FAST TRACK is a process designed to facilitate the development, and expedite the review of medicines to treat serious conditions and fill an unmet medical need. 3REAL-TIME ONCOLOGY REVIEW (RTOR) and Project Orbis is an initiative of the FDA Oncology Centre of Excellence (OCE) providing a framework for concurrent submission and review of oncology products among international partners.
PRIORITY REVIEW DESIGNATION is the US FDA's goal to take action on an application within 6 months.
ORPHAN DRUG DESIGNATION, intended for treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 patients in the US, or that affect more than 200,000 patients but are not expected to recover the costs of developing and marketing a treatment drug.
Imfinzi +/-treme+SOC SCLC 1L CASPIAN (US) Lynparza prostate PROfound (US)
Lynparza +Avastin ovarian 1L PAOLA-1 (US) Koselugo/ selumetinib NFI type 1 SPRINT (US) Calquence CLL ELEVATE-TN, ASCEND3 (US)
Lynparza prostate PROfound (CN)
Brilinta stroke THALES (US)
Lynparza pancreatic cancer POLO (JP)
Enhertu HER2+/HER2low gastric 3L DESTINY-Gastric01 (US)
Imfinzi Q4W regimen NSCLC, bladder (US) Tagrisso adjuvant NSCLC ADAURA (US)
Enhertu HER2+/HER2low gastric 3L DESTINY-Gastric01 (US)
Koselugo /selumetinib NFI type 1 SPRINT (JP) Imfinzi+CTx biliary tract 1L TOPAZ-1 (US)
Oncology - approved medicines and late-stage pipeline
Tagrisso (highly-selective, irreversible EGFRi)
NSCLC
Trial | Population | Patients | Design | Endpoints | Status |
Phase III ADAURA NCT02511106 | Adjuvant EGFRm NSCLC | 682 |
Global trial - 25 countries |
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Phase III LAURA NCT03521154 | Maintenance therapy in patients with locally advanced, unresectable EGFRm Stage III NSCLC whose disease has not progressed following platinum-based chemoradiation therapy | 200 |
Global trial - 17 countries |
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Phase III ASTRIS NCT02474355 | Real world setting in adult patients with advanced or metastatic, EGFRm T790M+ NSCLC | 3,020 | Single-arm trial - Tagrisso Global trial - 16 countries |
|
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Phase II ELIOS NCT03239340 | EGFR TKI treatment-naïve patients with locally-advanced or metastatic EGFRm NSCLC | 150 | Single arm trial - Tagrisso Global trial - five countries |
|
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Phase I ODIN-BM NCT03463525 | Patients with EGFRm NSCLC with brain metastases | 8 | Single-arm trial - Tagrisso |
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|
Tagrisso (highly-selective, irreversible EGFRi)
NSCLC, combinations
Trial | Population | Patients | Design | Endpoints | Status |
Phase III NeoADAURA NCT04351555 | Neoadjuvant EGFRm NSCLC | 351 | Arm 1: placebo plus plus pemetrexed/carboplatin or pemetrexed/cisplatin Arm 2: Tagrisso plus pemetrexed/carboplatin or pemetrexed/cisplatin Arm 3: Tagrisso Global trial - 23 countries |
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Phase III FLAURA2 NCT04035486 | 1st-line EGFRm NSCLC | 586 | Arm 1: Tagrisso plus pemetrexed/carboplatin or pemetrexed/cisplatin Arm 2: Tagrisso Global trial - 22 countries |
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Phase II ORCHARD NCT03944772 | Advanced EGFRm NSCLC patients who have progressed on first line Tagrisso treatment | 182 | Modular design platform trial:
Global trial - 8 countries |
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Phase II SAVANNAH NCT03778229 | EGFRm / MET+, locally advanced or metastatic NSCLC who have progressed following treatment with Tagrisso | 172 |
Global trial |
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Phase Ib TATTON NCT02143466 | Advanced EGFRm NSCLC TKI failure | 344 |
Enrolment to Tagrisso + Imfinzi arm will not restart Global trial |
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Imfinzi (PD-L1 mAb)
NSCLC, early disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase III MERMAID-1 NCT04385368 | Completely resected Stage II and III NSCLC | 332 |
| Primary endpoint:
Secondary endpoint
|
|
Phase III MERMAID-2 NCT04642469 | Completely resected Stage II-III NSCLC | 284 |
| Primary endpoint:
Secondary endpoint
|
|
Phase III AEGEAN NCT03800134 | Neoadjuvant NSCLC patients Stage II and III resected NSCLC (incl. EGFR/ALK positive) | 800 |
| Primary endpoint:
Secondary endpoint
|
|
Phase III ADJUVANT BR.31 NCT02273375 Partnered | Adjuvant NSCLC patients Ib (≥4cm) - stage IIIa resected NSCLC (incl. EGFR/ALK positive) | 1,360 |
Global trial | Primary endpoint:
Secondary endpoint:
|
|
Phase III PACIFIC-2 NCT03519971 | Unresected, locally-advanced NSCLC | 300 |
ex US global trial | Primary endpoint:
Secondary endpoint:
|
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Phase III PACIFIC-4 NCT03833154 | Imfinzi with SBRT in unresected, Stage I/II NSCLC | 630 |
| Primary endpoint:
Secondary endpoint:
| •FPCD: Q2 2019 •Data anticipated: 2022+ |
Phase III PACIFIC-5 NCT03706690 | Unresected, locally-advanced NSCLC | 360 |
ex US global trial, China focus | Primary endpoint:
Secondary endpoint:
|
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Phase II/III Lung Master Protocol NCT02154490 Partnered | Stage IV squamous NSCLC patients Biomarker-targeted 2L therapy | 140 |
| Primary endpoints:
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Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb)
Lung cancer, advanced disease
Approved medicines Late-stage development
Early development
Trial | Population | Patients | Design | Endpoints | Status |
Phase III PEARL NCT03003962 | NSCLC 1L | 650 |
Asia trial | Primary endpoint:
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Phase III POSEIDON NCT03164616 | NSCLC 1L | 1,000 |
| Primary endpoint:
|
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Phase II MAGELLAN NCT03819465 | NSCLC 1L | 200 |
| Primary endpoint:
|
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Phase III ADRIATIC NCT03703297 | Limited stage SCLC 1L following platinum-based concurrent chemoradiation therapy | 600 |
| Primary endpoints:
|
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Phase III CASPIAN NCT03043872 | Extensive stage SCLC 1L | 805 |
| Primary endpoint:
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Phase II BALTIC NCT02937818 | SCLC | 72 |
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Imfinzi (PD-L1 mAb)
Other cancers, early disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase III POTOMAC NCT03528694 | Non-muscle invasive bladder cancer | 975 |
| Primary endpoints:
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Phase III NIAGARA NCT03732677 | Muscle-invasive bladder cancer | 960 |
| Coprimary endpoints:
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Phase III EMERALD-1 NCT03778957 | Locoregional HCC | 710 |
| Primary endpoint PFS for Arm 1 vs Arm 3 Secondary endpoint PFS for Arm 2 vs Arm 3 , OS |
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Phase III EMERALD-2 NCT03847428 | Adjuvant therapy in HCC | 888 |
| Primary endpoint:
Secondary endpoint:
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Phase III KUNLUN NCT04550260 | Locally advanced, unresectable ESCC | 600 |
| Primary endpoint:
Secondary endpoint:
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Phase III MATTERHORN NCT04592913 | Resectable GC/GEJC | 900 |
| Primary endpoint:
Secondary endpoint:
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Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb)
Other cancers, advanced disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase III NILE NCT03682068 | Bladder cancer 1L | 885 |
| Primary endpoints:
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Phase III KESTREL NCT02551159 | HNSCC 1L | 823 |
| Primary endpoints:
Secondary endpoint:
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Phase III HIMALAYA NCT03298451 | HCC 1L | 1,324 |
| Primary endpoint:
Secondary endpoint:
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Phase II NCT02527434 | Urothelial bladder cancer triple-negative breast cancer pancreatic ductal-adenocarcinoma | 76 |
| Primary endpoint:
Secondary endpoints:
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Phase III TOPAZ-1 NCT03875235 | BTC 1L | 757 |
Global trial | Primary endpoint:
Secondary endpoint:
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Phase III CALLA NCT03830866 | Locally advanced cervical cancer | 714 |
Global trial | Primary
Secondary
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Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb)
Other cancers, advanced disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase III STRONG NCT03084471 | Advanced solid malignancies | 1,200 |
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Phase I NCT02658214 | Solid tumours | 80 |
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Phase I CLOVER NCT03509012 | HNSCC, NSCLC, SCLC | 102 |
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Phase II BEGONIA NCT03742102 | mTNBC 1L | 110 |
Global trial | Primary endpoint:
Secondary endpoint:
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Lynparza (PARP inhibitor)
Multiple cancers
Trial | Population | Patients | Design | Endpoints | Status |
Phase III OlympiA NCT02032823 Partnered | BRCAm adjuvant breast cancer | 1,836 |
Global trial partnership with BIG and NCI/NRG |
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Phase III PROfound NCT02987543 | Metastatic castration-resistant prostate cancer HRRm, 2L+ | 387 |
Global trial |
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Lynparza (PARP inhibitor)
Imfinzi combinations
Trial | Population | Patients | Design | Endpoints | Status |
Phase III DuO-O NCT03737643 | Advanced ovarian cancer 1L | 1,256 | Non tBRCAm (tumour BRCA) patients
Global trial | Primary endpoint:
Secondary endpoints:
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Phase III DUO-E NCT04269200 | Advanced and recurrent endometrial cancer 1L | 699 |
Global Trial | Primary endpoint
Secondary endpoints:
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Phase II ORION NCT03775486 | Stage IV NSCLC whose disease has not progressed following SoC chemo + Imfinzi Maintenance therapy 1L | 250 |
Global trial | Primary endpoint:
Secondary enpoints:
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Phase II BAYOU NCT03459846 | Platinum-Ineligible unresectable Stage IV urothelial cancer | 154 |
Global trial |
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Phase I / II MEDIOLA NCT02734004 | gBRCAm ovarian cancer 2L+ gBRCAm HER2-negative breast cancer 1-3L SCLC 2L+ Gastric cancer 2L+ | 148 |
Global trial | Primary endpoints:
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Phase I / II MEDIOLA (Ovarian expansion) NCT02734004 | gBRCAm ovarian cancer 2L+ Non-gBRCAm ovarian cancer 2L+ Non-gBRCAm ovarian cancer 2L+ | 115 |
Global trial | Primary endpoints:
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Lynparza (PARP inhibitor)
Other combinations
Trial | Population | Patients | Design | Endpoints | Status |
Phase III PAOLA-1 NCT02477644 Externally sponsored | Advanced ovarian cancer 1L maintenance | 806 |
Global trial | Primary endpoint:
Secondary endpoints:
|
|
Phase III PROpel NCT03732820 | Metastatic castration-resistant prostate cancer 1L | 720 |
Global trial | Primary Endpoint:
Secondary endpoints:
|
|
Phase II VIOLETTE NCT03330847 | TNBC | 350 |
Trial conducted in 15 countries: North America, Europe and Asia |
|
|
Phase II/III GY005 NCT02502266 Externally sponsored | Recurrent platinum resistant/refractory ovarian cancer | 680 |
US/Canada sites | Primary endpoints:
Secondary endpoints:
|
|
Phase II LYNK-002 NCT03742895 Partnered | HRRm or HRD-positive advanced cancer | 370 |
Global trial | Primary endpoints:
Secondary endpoints:
|
|
Phase III LYNK-003 NCT04456699 Partnered | Advanced colorectal cancer 1L maintanence | 525 |
Global trial | Primary endpoints:
Secondary endpoints:
|
|
Phase II DUETTE NCT04239014 | Ovarian post-PARPi maintenance PSR | 192 |
Global trial | Primary endpoint
Secondary endpoints
|
|
Enhertu (trastuzumab deruxtecan, HER2 ADC)
Breast cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase II DESTINY-Breast01 NCT03248492 | HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab emtansine | 230 | Randomised, open label, sequential assignment
| Primary endpoint ORR Secondary end points DoR, CBR, CBR, PFS, OS |
|
Phase III DESTINY-Breast02 NCT03523585 | HER2-positive, unresectable and/or metastatic breast cancer pretreated with prior standard of care HER2 therapies, including trastuzumab emtansine | 600 | Randomised open label parallel assignment
Physicians choice of
| Primacy endpoint PFS Secondary endpoints OS, ORR, DoR, CBR |
|
Phase III DESTINY-Breast03 NCT03529110 | HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane | 500 | Randomised open label parallel assignment
| Primary endpoint PFS Secondary endpoints OS, ORR, DoR, CBR |
|
Phase III DESTINY-Breast04 NCT03734029 | HER2-low, unresectable and/or metastatic breast cancer patients | 540 | Randomised open label parallel assignment
| Primary end point PFS Secondary end points OS, DoR, ORR |
|
Phase III DESTINY-Breast05 NCT04622319 | High-risk HER2-positive patients with residual invasive breast cancer following neoadjuvant therapy | 1,600 | Randomised open label parallel assignment
| Primary end point IDFS Secondary end points DFS, OS, DRFI, BMFI |
|
Phase III DESTINY-Breast06 NCT04494425 | HER2-Low, HR+ breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting | 850 | Randomised open label parallel assignment
| Primary end point PFS Secondary end points OS, DoR, ORR |
|
Phase Ib/II DESTINY-Breast07 NCT04538742 | HER2-positive metastatic breast cancer | 350 | Randomised open label sequential assignment
| Primary end point AE, SAE Secondary end points ORR, PFS, DoR, OS |
|
Phase Ib DESTINY-Breast08 NCT04556773 | HER2-low metastatic breast cancer | 185 | Non-Randomised open label parallel assignment
| Primary end point AE, SAE Secondary end points ORR, PFS, DoR, OS |
|
Enhertu (trastuzumab deruxtecan, HER2 ADC)
Gastric cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase II DESTINY-Gastric01 NCT03329690 | HER2-overexpressing advanced gastric or gastroeosophogeal junction adenocarcinoma patients who have progressed on two prior treatment regimens | 233 | Randomised open label parallel assignment
Asian trial 2 countries | Primary end point ORR Secondary end points PFS, OS, DoR, DCR, TTF, range of PK endpoints |
|
Phase II DESTINY-Gastric02 NCT04014075 | HER2-positive gastric cancer that cannot be surgically removed or has spread | 79 | Open label single group assignment
| Primary endpoint ORR Secondary endpoints PFS, ORR, OS, DoR |
|
Phase Ib/II DESTINY-Gastric03 NCT04379596 | HER2-overexpressing gastric or gastroeosophogeal junction cancer patients | 220 |
Global trial 8 countries | Part 1 Primary endpoint safety Part 2 Primary endpoint ORR Secondary end points DoR, DCR, PFS, OS, range of PK endpoints, ADAs |
|
Phase III DESTINY-Gastric04 NCT04704934 | HER2-positive gastric cancer or gastro-esophageal junction adenocarcinoma patients who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy | 490 | Open label randomised parallel group assignment
| Primary endpoint: OS Secondary endpoints: ORR, DoR, PFS, DcR, safety |
|
Enhertu (trastuzumab deruxtecan, HER2 ADC)
Other cancers
Trial | Population | Patients | Design | Endpoints | Status |
Phase II DESTINY-Lung01 NCT03505710 Partnered | HER2-over-expressing or mutated, unresectable and/or metastatic NSCLC | 170 | Non randomised parallel group assignment
| Primary endpoint ORR Secondary endpoints DoR, PFS, OS |
|
Phase II DESTINY-Lung02 NCT04644237 Partnered | HER2-Mutated, Unresectable and/or Metastatic NSCLC | 150 | Randomised parallel group assignment
| Primary endpoint: ORR Secondary endpoints: DoR, DCR, PFS, OS, PK |
|
Phase Ib DESTINY-Lung03 NCT04686305 | HER2-over-expressing, unresectable and/or metastatic NSCLC | 120 | Non randomised parallel group assignment
| Primary endpoint: safety Secondary endpoints: ORR, DoR, DCR, PFS, OS, range of PK endpoints |
|
Enhertu (trastuzumab deruxtecan, HER2 ADC)
Other cancers
Trial | Population | Patients | Design | Endpoints | Status |
Phase II DPT02 NCT04482309 | HER2 expressing tumours | 280 | Non randomised single group assignment
| Primary endpoint: ORR Secondary endpoints: DoR, DCR, PFS, OS |
|
Phase II DPT01 NCT04639219 | HER2m expressing tumours | 100 | Non-randomised single group assignment
| Primary endpoint: ORR Secondary endpoints: DoR, DCR, PFS, PK |
|
Phase II DESTINY-CRC01 NCT03384940 | HER2-expressing advanced colorectal cancer | 90 | Non randomised single group assignment
| Primary endpoint ORR Secondary endpoints PFS, OS, DoR, range of PK endpoints |
|
Phase I J101 NCT02564900 | Advanced solid malignant tumours | 278 | Non randomised single group assignment
| Primary end points ORR, number of subjects with AEs, tumour response Secondary endpoints PK |
|
Phase I NCT04042701 | HER2-expressing locally advanced/metastatic breast or NSCLC | 115 |
Global trial 2 countries | Primary end points DLT, ORR Secondary endpoints DoR, DCR, PFS, TTR, OS |
|
Phase I NCT03523572 | HER2-expressing breast and urothelial cancer | 99 |
Global trial 7 countries | Primary end points DLT, ORR, TEAEs Secondary endpoints DoR, DCR, PFS, TTR, OS, ORR (investigator) |
|
Calquence (BTK inhibitor)
Blood cancers
Trial | Population | Patients | Design | Endpoint(s) | Status |
Phase III ACE-CL-007 (ELEVATE-TN) NCT02475681 | Previously untreated CLL | 535 |
|
|
|
Phase III ACE-CL-311 NCT03836261 | Previously untreated CLL fit | 780 |
|
|
|
Phase III ACE-CL-309 (ASCEND) NCT02970318 | Relapsed/refractory CLL | 306 |
|
|
|
Phase III ACE-CL-006 (ELEVATE-RR) NCT02477696 | Relapsed/refractory high risk CLL | 533 |
|
|
|
Phase III ACE-LY-308 NCT02972840 | Previously untreated MCL | 546 |
|
|
|
Phase III ESCALADE NCT04529772 | DLBCL | 600 | Calquence + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone |
|
|
Phase II ACE-CL-208 NCT02717611 | Relapsed/ refractory CLL, intolerant to ibrutinib | 60 | Calquence monotherapy |
|
|
Phase II 15-H-0016 NCT02337829 | Relapsed/refractory and treatment naïve/del17p CLL/SLL | 48 | Calquence monotherapy
|
|
|
Phase I/II ACE-CL-001 NCT02029443 | CLL/SLL/Richter's transformation | 306 | Calquence monotherapy Dose escalation and expansion |
|
|
Calquence (BTK inhibitor)
Blood cancers
Trial | Population | Patients | Design | Endpoint(s) | Status |
Phase I/II ACE-LY-001 NCT02328014 | B-cell malignancies | 40 | Dose escalation and expansion trial of the combination of Calquence and ACP-319 (Pi3K inhibitor) |
|
|
Phase I/II ACE-LY-005 NCT02362035 | Haematological malignancies | 161 | Calquence + pembrolizumab |
|
|
Phase I/II ACE-WM-001 NCT02180724 | Waldenstrom microglobulinaemia | 106 | Calquence monotherapy |
|
|
Phase Ib ACE-LY-002 NCT02112526 | Relapsed/refractory de novo activated B-cell DLBCL | 21 | Calquence monotherapy |
|
|
Phase Ib ACE-LY-106 NCT02717624 | MCL | 70 | Calquence in combination with bendamustine and rituxumab
|
|
|
Phase Ib ACE-MY-001 NCT02211014 | Relapsed/refractory MM | 28 |
|
|
|
Phase I ACE-LY-003 NCT02180711 | Relapsed/refractory follicular lymphoma | 80 |
|
|
|
Phase I ACE-CL-002 NCT02157324 | Relapsed/refractory CLL/ SLL | 12 | Calquence in combination with ACP-319 dose escalation |
|
|
Phase I ACE-CL-003 NCT02296918 | CLL/SLL/PLL | 69 | Calquence + obinutuzumab
Calquence + venetoclax + rituxumab
|
|
|
Calquence (BTK inhibitor)
Blood and other cancers
Trial | Population | Patients | Design | Endpoint(s) | Status |
Phase I NCT03198650 | Japanese adults with advanced B-cell malignancies | 34 |
|
|
|
Phase I/II CL-110 NCT03328273 | CLL r/r | 62 |
|
| FPCD: Q1 2018 Data anticipated: H1 2021 |
Phase I/II LY-110 NCT03205046 | B-cell malignancies r/r | 25 |
|
| FPCD: Q3 2017 Data anticipated: H2 2020 |
Phase III CL-312 NCT04008706 | CLL TN and r/r | 600 |
|
| Data anticipated: 2022+ |
Phase Ib/II PRISM NCT03527147 | Relapsed/refractory aggressive NHL | 88 |
An open-label platform trial with trial centres in US and UK |
| FPCD: Q2 2018 Data anticipated: 2021 |
Phase Ib/II ACE-ST-209 NCT02586857 | ≥ 2L glioblastoma multiforme | 52 |
|
|
|
Phase I/II D8220C0007 NCT03932331 | Chinese adults r/r MCL and r/r CLL | 105 |
|
|
|
Phase I D8220C00018 NCT04488016 | Healthy volunteers | 28 | Part 1: Rel bioavailabilty for capsule vs tablet Part 2: Rel bioavailabilty for oral solution of tablet |
|
|
Koselugo (selumetinib, MEK inhibitor)
Paediatric neurofibromatosis type 1, solid tumours
Trial | Population | Patients | Design | Endpoints | Status |
Phase II SPRINT NCT01362803 Partnered | Paediatric NF1 | 50 (stratum 1) 25 (Stratum 2) |
|
|
|
Phase Ib Koselugo + MK-8353 (ERK inhibitor) NCT03745989 Partnered (Merck Lead trial) | Advanced solid tumours | 80 (dose escalation trial) | Phase Ib open-label trial of MK-8353 in combination with Koselugo in participants with advanced solid tumours |
|
|
Phase I Japan PK / Safety study Partnered | Paediatric Inoperable NF1-PN patients | 9-12 | Open-label Phase I clinical study to assess safety and PK of Koselugo in Japanese paediatric NF1-PN patients |
|
|
Phase I China PK / Safety / Efficacy study | Pediatric (2-17 years old), adult NF1 | 32 | Single arm with 3 phases;
| Primary: Safety/tolerability and PK Secondary: Efficacy (ORR, DoR; TTR; PFS) | FPCD: Q4 2020 |
Lumoxiti (moxetumomab pasudotox,CD22 mAb)
Blood cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase III PLAIT NCT01829711 Partnered | Adults with relapsed or refractory HCL | 80 |
|
|
|
Savolitinib (MET inhibitor)
NSCLC and other cancers
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT01985555 Partnered | Advanced NSCLC (all comers) | 85 |
Conducted in China |
|
|
Phase II NCT02897479 Partnered | Lung PSC and other NSCLC | 65 |
Conducted in China |
|
|
Phase II NCT04606771 | EGFRm/MET amplified advanced NSCLC | 56 |
|
|
|
Capivasertib (AKT inhibitor)
Breast cancer, prostate cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase III CAPItello-290 NCT03997123 | Locally advanced or metastatic TNBC | 800 | Double-blind randomised comparative trial
|
|
|
Phase III CAPItello-291 NCT04305496 | Locally advanced (Inoperable) or metastatic HR+/HER2− breast cancer | 834 | Double-blind randomised comparative trial
|
|
|
Phase III CAPItello-281 NCT04493853 | De novo PTEN deficient metastatic hormone sensitive prostate cancer | 1,000 | Double-blind randomised comparative trial
|
|
|
Monalizumab (NKG2a mAb)
Cancers
Trial | Population | Patients | Design | Endpoints | Status |
Phase III INTERLINK-1 NCT04590963 | Recurrent or Metastatic SCCHN, 2L | 600 |
Global trial |
|
|
Phase I/II NCT02671435 | Advanced solid tumours | 381 | Escalation phase
Expansion phase
Exploration phase
Global trial | Primary endpoints:
|
|
Camizestrant (AZD9833, oral SERD)
Breast cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase III NCT04711252 | ER+ HER2- breast cancer | 1,342 | A randomised, multicentre, double-blind, Phase III trial of camizestrant plus palbociclib versus anastrozole plus palbociclib for the treatment of patients with oestrogen receptor-positive, HER2-negative advanced breast cancer who have not received any systemic treatment for advanced disease |
|
|
Phase I NCT03616587 | ER+ breast cancer | 266 |
|
|
|
Phase II NCT04214288 | ER+ breast cancer | 288 |
|
|
|
Phase II NCT04588298 | ER+ breast cancer | 84 |
|
|
|
Phase I NCT04541433 | ER+ breast cancer | 18 |
|
|
|
Phase I NCT04546347 | Healthy volunteers | 32 |
|
|
|
Datopotamab deruxtecan (TROP2 ADC)
NSCLC
Trial | Population | Patients | Design | Endpoints | Status |
Phase III TROPION-Lung01 NCT04656652 Partnered | NSCLC (without actionable mutation) | 590 | Randomised, open label
Global trial |
|
|
Phase II TROPION-Lung05 NCT04484142 Partnered | NSCLC (with actionable mutation) | 150 | Randomised, open label
Global trial |
|
|
Phase I NCT03401385 Partnered | NSCLC TNBC | 350 | Open label, two-part (dose escalation, dose expansion)
Japan, US |
|
|
Phase I TROPION-Lung02 NCT04526691 Partnered | NSCLC (without actionable mutation) | 86 | Open label, combination with pembrolizumab, two-part (dose escalation, dose expansion)
Japan, US |
|
|
Phase I TROPION-Lung04 NCT04612751 Partnered | NSCLC (without actionable mutation) | 74 | Open label, combination with Imfinzi, two-part (dose escalation, dose expansion)
US, Japan |
|
|
Oncology - early-stage development
Imfinzi (PD-L1 mAb)
Cancer
Trial | Compound | Population | Patients | Design | Endpoints | Status |
Phase I/II STUDY 1108 NCT01693562 | Imfinzi | Solid tumours | 1,022 |
Global trial - nine countries |
|
|
Phase I NCT02117219 | Imfinzi, azacitidine | Myelodysplastic syndrome | 79 | Dose escalation and dose expansion trial
Global trial - four countries |
|
|
Phase I NCT02900157 | MEDI9090 | Solid tumours | 42 | Multi-centre, open-label, single-arm trial for adult subjects US and Japan trial centers |
|
|
Phase II HUDSON NCT03334617 | Imfinzi Lynparza vistusertib ceralasertib (AZD6738) danvatirsen oleclumab Enhertu cediranib | NSCLC | 340 | 5 modules encompassing 16 cohorts
Open-label, biomarker-directed, multi-centre Phase II umbrella trial in patients with NSCLC, who progressed on an anti-PD-1/PD-L1 containing therapy |
|
|
Phase II COAST NCT03822351 | Imfinzi | Stage III NSCLC unresectable | 189 |
| Primary
|
|
Phase II NeoCOAST NCT03794544 | Imfinzi | Resectable, early stage NSCLC | 84 |
| Primary
|
|
Imfinzi (PD-L1 mAb)
Cancer
Trial | Compound | Population | Patients | Design | Endpoints | Status |
Phase Ib/II COLUMBIA 1 NCT04068610 | Imfinzi | 1L metastatic MSS-CRC | 112 |
| Primary
Secondary
|
|
Imfinzi (PD-L1 mAb) + tremelimumab (CTLA-4 mAb)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase Ib/II STUDY 22 NCT02519348 | Hepatocellular carcinoma | 545 |
|
|
|
Phase Ib STUDY 006 NCT02000947 | NSCLC (Immunotx naïve and Immunotx pretreated patient cohorts) | 459 |
North American, EU and ROW trial centres | Primary endpoints:
|
|
Phase I STUDY 10 NCT02261220 | Solid tumours (basket trial) | 380 |
North American, EU and ROW trial centres | Primary endpoints:
|
|
Imfinzi (PD-L1 mAb) + MEDI0457 (DNA HPV Vaccine)
Head and neck squamous cell carcinoma (HNSCC)
Trial | Population | Patients | Design | Endpoints | Status |
Phase Ib/IIa NCT03162224 | HPV associated recurrent/metastatic head and neck cancer | 50 | Multi-centre, open label trial to evaluate the safety and efficacy of combination treatment with MEDI0457 and Imfinzi | Primary endpoints: Safety & Tolerability, ORR Secondary endpoints: PK, ADA, DCR, OS, PFS |
|
AZD0466 (Bcl2/xL inhibitor)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04214093 | Advanced hematologic malignancies or solid tumours | 102 | Monotherapy dose escalation, consisting of two arms:
|
|
|
MEDI1191 (IL12 modRNA)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03946800 | Advanced solid tumours | 87 | First-time-in-human Phase I, open-label, dose-escalation and expansion trial of MEDI1191 administered intratumourally as monotherapy and in combination with Imfinzi |
|
|
AZD1390 (ATM inhibitor)
Cancer
Trial | Population | Subjects | Design | Endpoints | Status |
Phase I NCT03423628 | Recurrent glioblastoma eligible for re-irradiation, brain metastases and leptomeningeal disease, newly-diagnosed glioblastoma patients | 132 |
AZD1390 in combination with radiation therapy in patients with GBM and brain metastases from solid tumours
Conducted across seven sites in USA and UK |
|
|
Adavosertib (WEE-1 inhibitor)
Ovarian cancer, uterine serous cancer, solid tumours
Trial | Population | Patients | Design | Endpoints | Status |
Phase II D6010C00004 NCT02272790 | Platinum-resistant (PR) ovarian cancer | 95 |
Global trial |
|
|
Phase I D6015C00002 NCT02617277 | Advanced solid tumours | 56 |
Conducted in US |
|
|
Phase II D601HC00002 NCT04590248 | Uterine serous carcinoma | 120 |
|
|
|
MEDI2228 (BCMA antibody drug conjugate)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03489525 | Relapsed/refractory multiple myeloma | 142 | First-time-in-human Phase I, multi-centre, open-label, single-arm, dose-escalation, and dose-expansion trial for adult subjects | Primary endpoints:
|
|
AZD2811NP (AURN)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT02579226 | Solid tumours | 72 |
|
|
|
Phase I NCT03217838 | AML/high-risk MDS | 124 |
|
|
|
AZD4573 (CDK9 inhibitor)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03263637 | Relapsed/refractory haematologic malignancies | 45 | Arm 1: dose escalation in haematological malignancies excluding AML/ALL/high-risk MDS/CMML/CLL. Arm 2: dose escalation in relapsed or refractory AML, ALL, high-risk MDS, CMML, CLL and Richter's syndrome. i.v. route of administration Trial conducted in NL, UK, GE | Primary:
Secondary:
|
|
Phase I/II NCT04630756 | Relapsed/refractory haematologic malignancies | 78 | Modular design platform trial:
| Primary:
Secondary:
|
|
AZD4635 (A2AR inhibitor)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT02740985 | Phase Ia: patients with advanced solid tumours Phase Ib: Post-immunotherapy NSCLC Other post-immunotherapy solid tumours Immune checkpoint-naïve mCRPC Immune checkpoint-naïve CRC Other immune checkpoint-naïve solid tumours | 313 | Phase Ia - solid tumours or mCPRC:
Phase Ib: AZD4635 monotherapy or AZD4635 + Imfinzi dose expansions in NSCLC, mCRPC, CRC and other post-immunotherapy and immune checkpoint-naïve solid tumours Conducted at sites in the US | Primary outcome measure:
Secondary outcome measures:
|
|
Phase I NCT03710434 | Healthy male volunteers | 21 |
Both parts conducted at a site in the UK | Primary outcome measures:
|
|
Phase II NCT04089553 | Prostate cancer | 60 | ARM 1: AZD4635 + Imfinzi ARM 2: AZD4635 + oleclumab Conducted at sites in the US |
|
|
Phase I NCT03980821 | Japanese patients with advanced solid malignancies | 12 | AZD4635 dose escalation Conducted at sites in Japan | Primary outcome measure:
Secondary outcome measure:
|
|
Phase II NCT04495179 | Prostate cancer | 160 | ARM A: AZD4635 + Imfinzi ARM B: AZD4635+ Imfinzi + cabazitaxel Conducted at sites in US, Europe, UK and Korea |
|
|
AZD5153 (BRD4 inhibitor)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I/Ib NCT03205176 | Relapsed/refractory solid tumours, lymphomas | 60 | Monotherapy dose escalation in advanced solid tumours and lymphomas Dose escalation of AZD5153 in combination with Lynparza in platinum resistant/refractory HGS patients. |
|
|
AZD5305 (PARP inhibitor)
Solid tumours
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04644068 | Advanced, metastatic HER2 neg. with BRCAm, PALB2m or RAD51C/Dm Breast cancer Advanced, metastatic TNBC BRCAm, PALB2m or RAD51C/Dm PSR ovarian cancer HRD+ve1 (non-BRCAm or PALB2m or RAD51C/Dm) PSR ovarian cancer PSR ovarian cancer | 612 | A modular phase I/IIa, open-label, multicentre trial to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of ascending doses of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies |
|
|
MEDI5395 (rNDV GMCSF)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03889275 | Select advanced solid tumours | 188 | First-time-in-human Phase I, open-label, dose-escalation and expansion arm of MEDI5395 in combination with Imfinzi |
|
|
MEDI5752 (PD-1/CTLA-4 bispecific mAb)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I/IIa NCT03530397 | Advanced solid tumours | 261 | Open-label, dose-escalation and dose-expansion:
| Primary endpoints:
Secondary endpoints:
|
|
Phase Ib NCT04522323 | Advanced renal cell carcinoma | 77 | Open-label, dose-escalation and dose-expansion to explore the safety, tolerability and anti-tumour activity of MEDI5752 in combination with axitinib: | Primary endpoint:
Secondary endpoints:
|
|
AZD5991 (MCL1 inhibitor)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I/Ib/IIa NCT03218683 | Relapsed/refractory haematologic malignancies | 121 |
|
|
|
Ceralasertib (AZD6738, ATR inhibitor)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT02264678 | Solid tumours | 250 |
Trial conducted in North America, Europe and South Korea |
|
|
Phase I NCT03022409 | HNSCC | 44 | Window of opportunity
Trial conducted in US, France, Taiwan and the UK |
|
|
Phase II PLANETTE NCT04564027 | Solid tumours mCRPC | 52 |
| Cohort A: ORR Cohort B: Composite RR |
|
AZD7648 (selective DNA-PK inhibitor)
Advanced solid tumours
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03907969 | Advanced malignancies | 234 |
|
|
|
AZD8701 (FOXP3 antisense oligonucleotide)
Solid tumours
Trial | Population | Patients | Design | Endpoints | Status |
Phase I/Ib NCT04504669 | Advanced solid tumours | 123 | Dose escalation and dose expansion trial Arm 1: AZD8701 monotherapy Arm 2: AZD8701 & Imfinzi combination therapy Global trial - four countries - US, CA, FR, ES i.v. route of administration | Primary endpoints: safety & tolerability Secondary endpoints: PK, PD, preliminary anti-tumour activity |
|
MEDI9253 (rNDV-IL12)
Solid tumours
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04613492 | Advanced solid tumours | 86 | First-time-in-human Phase I, open-label, dose-escalation and expansion arm of MEDI9253 in combination with Imfinzi |
|
|
Oleclumab (CD73 mAb)
Cancer
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT02503774 | Advanced malignancies | 348 | Dose escalation phase
Dose expansion phase
US, South Korean and Australian trial centres | Primary endpoints:
|
|
Phase Ib/II NCT03611556 | Pancreatic 1L and 2L with prior gemcitabine-based chemotherapy | 339 |
US, Norway, Spain and Australian trial centres | Primary endpoints:
|
|
IPH5201 (CD39 mAb)
Solid tumours
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04261075 Partnered | Advanced Solid tumours | 204 |
| Primary endpoints: AE, SAE, DLT Secondary endpoints: OR, DC, PK, ADA |
|
BioPharmaceuticals - approved medicines and late-stage pipeline
Farxiga (SGLT2 inhibitor)
Heart failure and chronic kidney disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase III Dapa-HF NCT03036124 | CHF patients with HFrEF | 4,744 |
|
|
|
Phase III Dapa-CKD NCT03036150 | Patients With CKD | 4,304 |
Global trial - 21 countries |
|
|
Phase III DELIVER NCT03619213 | CHF patients with HFpEF | 6,100 |
|
|
|
Phase III DETERMINE-preserved NCT03877224 | CHF patients with HFpEF | 504 |
| Family of primary endpoints:
|
|
Phase III DETERMINE-reduced NCT03877237 | CHF patients with HFrEF | 313 |
| Family of primary endpoints:
|
|
Phase III DAPA-MI NCT04564742 | Patients with myocardial infarction | 6,400 |
|
|
|
Brilinta (P2Y12 receptor antagonist)
Cardiovascular risk reduction
Trial | Population | Patients | Design | Endpoints (primary) | Status |
Phase III THEMIS NCT01991795 | Patients with type-2 diabetes and coronary artery disease without a previous history of MI or stroke | 19,000 |
Global trial - 42 countries |
Secondary endpoints:
|
|
Phase III THALES NCT03354429 | Patients with acute ischaemic stroke or transient ischaemic attack | 11,000 |
Global trial - 28 countries | Primary endpoint:
Secondary endpoints include:
|
|
Lokelma (sodium zirconium cyclosilicate)
Hyperkalaemia
Trial | Population | Patients | Design | Endpoints | Status |
Phase II PRIORITIZE HF NCT03532009 | Patients with chronic heart failure and hyperkalaemia or at high risk of developing hyperkalaemia | 182 |
Global trial - nine countries |
|
|
Phase IIIb DIALIZE China NCT04217590 | Patients with ESRD with hyperkalemia and on stable haemodialysis | 134 |
China |
|
|
Phase III HARMONIZE Asia NCT03528681 | Hyperkalaemia | 337 | Open-label Lokelma 10g TID for 48 hours followed by:
China, India |
|
|
Roxadustat (HIF-PH inhibitor)
Anaemia
Trial | Population | Patients | Design | Endpoints | Status |
Phase III ANDES NCT01750190 Partnered | Anaemia in CKD in patients not receiving dialysis | 922 |
Global trial |
|
|
Phase III ALPS NCT01887600 Partnered | 597 |
Global trial |
|
Sponsored by Astellas | |
Phase III DOLOMITES NCT02021318 Partnered | 616 |
Global trial |
|
Sponsored by Astellas | |
Phase III OLYMPUS NCT02174627 | 2,781 |
Global trial |
|
Sponsored by AstraZeneca | |
Phase III ROCKIES NCT02174731 | Anaemia in CKD in patients receiving dialysis | 2,133 |
Global trial |
|
Sponsored by AstraZeneca |
Phase III SIERRAS NCT02273726 Partnered | 741 |
Global trial |
|
| |
Phase III PYRENEES NCT02278341 Partnered | 838 |
Global trial |
|
Sponsored by Astellas |
Roxadustat (HIF-PH inhibitor)
Anaemia
Trial | Population | Patients | Design | Endpoints | Status |
Phase III HIMALAYAS NCT02052310 Partnered | Anaemia in newly initiated dialysis patients | 1,043 |
Global trial |
|
|
Phase III NCT03263091 Partnered | Anaemia in lower risk MDS patients | 184 | Open label roxadustat lead-in Arm 1: roxadustat Arm 2: placebo US/global trial |
|
Sponsored by FibroGen |
Phase II/III NCT03303066 Partnered | Anaemia in lower risk MDS patients | 175 | Open label roxadustat lead-in Arm 1: roxadustat Arm 2: placebo China |
|
Sponsored by FibroGen |
Phase II NCT04076943 Partnered | Anemia in patients receiving chemotherapy treatment for non-myeloid malignancies | 100 | US |
|
Sponsored by FibroGen |
Eklira/Tudorza (LAMA, DPI)
COPD
Trial | Population | Number of patients | Design | Endpoints | Status |
Phase I NCT03276052 | Healthy Chinese volunteers | 20 | Open-label, 2-period ascending dose incomplete block, cross-over trial
Global trial - one Country |
|
|
Duaklir Genuair (LAMA/LABA, DPI)
COPD
Trial | Population | Patients | Design | Endpoints | Status |
Phase III AVANT NCT03022097 | Patients with stable COPD | 1,060 |
Global trial - five countries | Primary endpoints:
|
|
Breztri, Trixeo (PT010, LAMA/LABA/ICS, pMDI)
Asthma
Trial | Population | Patients | Design | Endpoints | Status |
Phase III KALOS NCT04609878 | Severe asthma | 2,800 | Treatments (24 to 52 week variable length)
Randomised, double-blind, double dummy, parallel group and multicentre Multi-country |
|
|
Phase III LOGOS NCT04609904 | Severe asthma | 2,800 | Treatments (24 to 52 week variable length)
Randomised, double-blind, double dummy, parallel group and multicentre Multi-country |
|
|
Daliresp/Daxas (PDE4 inhibitor, oral)
COPD
Trial | Population | Patients | Design | Endpoints | Status |
Post Launch PASS NCT03381573 | COPD | 124,080 |
|
|
|
Fasenra (IL5R mAb)
Severe, uncontrolled asthma
Trial | Population | Patients | Design | Endpoints | Status |
Phase III MELTEMI NCT02808819 | A multi-centre, open-label, safety extension trial with Fasenra for asthmatic adults on ICS plus LABA2 Agonist Age 18-75 years | 447 |
Global trial - 15 countries |
|
|
Phase IIIb PONENTE NCT03557307 | Severe eosinophilic asthmatics receiving HD ICS + LABA and chronic OCS with or without additional asthma controller(s). Age 18 Years and older | 598 | Arm 1: Fasenra 30mg Q8W s.c. 38-week trial Global trial - 16 countries |
|
|
D3250C00036 China ICS/LABA Trial (MIRACLE) NCT03186209 | Severe, uncontrolled asthma, despite background controller medication, MD & HD ICS + LABA ± chronic OCS Age 12-75 years | 666 |
56-week trial Global trial - 4 countries |
|
|
Fasenra (IL5R mAb)
Severe, uncontrolled asthma
Trial | Population | Patients | Design | Endpoints | Status |
Phase III BORA NCT02258542 | Severe asthma, inadequately controlled despite background controller medication, MD & HD ICS + LABA ± chronic OCS Age 12-75 years | 2,133 |
108-week (adolescents) Global trial - 24 countries |
|
|
Phase III GREGALE NCT02417961 | Severe asthma, inadequately controlled despite background controller medication, MD & HD ICS + LABA ± chronic OCS Age 18-75 years | 162 |
28-week (adults) Global trial - two countries |
|
|
Phase lll ARIA NCT02821416 | A double-blind, randomised, parallel group, placebo-controlled multi-centre trial to evaluate the effect of Fasenra on allergen-induced inflammation in Mild, atopic asthmatic Age 18-65 years | 46 |
37-week trial |
|
|
Phase lll ALIZE NCT02814643 | A multi-centre, randomised, double-blind, parallel group, placebo-controlled, Phase IIIb trial to evaluate the potential effect of Fasenra on the humoral immune response to the seasonal influenza vaccination in adolescent and young adult patients with severe asthma Ages 12-21 years | 103 |
12-week trial | Primary endpoints:
|
|
Fasenra (IL5R mAb)
Severe, uncontrolled asthma, COPD
Trial | Population | Patients | Design | Endpoints | Status |
Phase III GRECO NCT02918071 | Severe asthma on ICS-LABA Age 18-75 years | 121 | Open label Fasenra 30mg Q4w 28-week trial Global trial - two countries |
|
|
Phase lllb ANDHI NCT03170271 | A multi-centre, randomised, double-blind, parallel group, placebo controlled, Phase IIIb trial to evaluate the safety and efficacy of Fasenra 30 mg s.c. in patients with severe asthma uncontrolled on SoC treatment. Age 18-75 | 659 |
24-week trial Global trial - 15 countries |
|
|
Phase I AMES NCT02968914 | Healthy volunteers age 18-55 years | 180 | Open label trial to compare 30 mg Fasenra PK administered by APFS or AI device 8-week trial Global trial - two countries |
|
|
Phase III RESOLUTE NCT04053634 | Patients with moderate to very severe COPD with a history of frequent exacerbations on a background triple therapy (ICS/LABA/LAMA) Age 40-85 years | 868 |
|
|
|
Fasenra (IL5R mAb)
Nasal polyposis and other eosinophilic diseases
Trial | Population | Patients | Design | Endpoints | Status |
Phase III OSTRO NCT03401229 | Patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy Age 18-75 years | 413 |
56-week trial Global trial- 8 countries |
|
|
Phase III ORCHID NCT04157335 | Patients with eosinophilic chronic rhinosinusitis with severe nasal polyposis Age 18-75 years | 148 | Arm 1: Fasenra 30mg Q8W s.c. Arm 2: placebo Q8W s.c. 56-week trial Asian countries (4 countries) |
|
|
Phase III MANDARA NCT04157348 | Patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy Age 18 years and older | 140 |
52-week trial with a minimum 1 year open label extension Global trial- 9 countries |
|
|
Phase III NATRON NCT04191304 | Patients with HES (history of persistent eosinophilia >1500 cells/μL with evidence of end organ manifestations attributable to eosinophilia) and signs or symptoms of HES worsening/flare at Visit 1 Age 12 years and older | 120 |
24-week trial with a minimum 1 year open label extension Global trial- 9-12 countries |
|
|
Phase III MESSINA NCT04543409 | Documented diagnosis of EoE Age 12 to 65 years | 170 |
24-week double blind treatment period and open label period(s) |
Histologic response at week 24 Change from baseline in DSQ score at week 24 |
|
Fasenra (IL5R mAb)
Dermatology
Trial | Population | Patients | Design | Endpoints | Status |
Phase III FJORD | Patients with symptomatic (newly diagnosed or relapsing) Bullous Pemphigoid | 120 |
36-week double blind treatment period and open label period Global trial |
Proportion of patients with sustained (≥2 months) remission off OCS at 36 weeks |
|
Phase II ARROYO | Patients with moderate/severe Chronic Spontaneous Urticaria, and resistant to H1 treatment | 160 |
24-week double blind treatment period and open label period Global trial |
Change from baseline in ISS7 at week 12 |
|
Phase II HILLIER NCT04605094 | Patients with moderate to severe Atopic Dermatitis despite treatment with topical medications | 160-200 |
16-week double blind treatment period and open label periods Global trial |
Proportion of patients with an IGA 0/1 and a decrease in IGA of ≥ 2 points at week 16 |
|
Tezepelumab (TSLP mAb)
Severe, uncontrolled asthma
Trial | Population | Patients | Design | Endpoints | Status |
Phase III NAVIGATOR NCT03347279 Partnered | Severe asthma Age 12-80 years | 1,061 |
52 week trial Global trial - 18 countries |
|
|
Phase III SOURCE NCT03406078 Partnered | Severe asthma Age 18-80 years | 150 |
48 week trial Global trial - seven countries |
|
|
Phase III DESTINATION NCT03706079 Partnered | Severe asthma Age 12-80 years | ~975 |
Extension trial to NAVIGATOR and SOURCE. 52 week trial (subjects from NAVIGATOR); 56 week trial (subjects from SOURCE) Global trial - 18 countries |
|
|
Phase III PATH-HOME NCT03968978 Partnered | Severe asthma Age 12-80 years | 216 |
24 week trial Global trial - 4 countries | Primary endpoint: Proportion of health care professionals and patients /caregivers who successfully administrated tezepelumab in clinic and at home with an APFS or an AI, respectively |
|
Tezepelumab (TSLP mAb)
Severe, uncontrolled asthma & COPD
Trial | Population | Patients | Design | Endpoints | Status |
Phase II CASCADE NCT03688074 Partnered | Severe asthma Age 18-75 years | 116 |
28 week trial Global trial - five countries |
|
|
Phase III DIRECTION NCT03927157 Partnered | Severe asthma Age 18-80 years | 396 |
52 week trial Regional Asia trial - three countries |
|
|
Phase III NOZOMI NCT04048343 Partnered | Severe asthma 12-80 years | 65 | Arm 1: tezepelumab s.c. 52 week trial Local trial - Japan |
|
|
Phase IIa COURSE NCT04039113 Partnered | Moderate to very severe COPD Age 40-80 | 282 |
52 week trial Global trial - 10 countries |
|
|
PT027 (SABA/ICS, pMDI)
Asthma
Trial | Population | Patients | Design | Endpoints | Status |
Phase III MANDALA NCT03769090 Managed by Avillion | Moderate to severe asthma | 3,100 | Treatments (minimum 24-week treatment period)
Randomised, double-blind, multi-centre, parallel group Multi-country | Primary endpoint:
Secondary endpoints:
|
|
Phase III DENALI NCT03847896 Managed by Avillion | Mild to moderate asthma | 1,000 | Treatments (12 week treatment period)
Randomised, double-blind, multi-centre and parallel-group Multi-country | Dual primary endpoints:
|
|
Phase III TYREE NCT04234464 Managed by Avillion | Asthma with exercise induced bronchoconstriction | 60 | Treatments (single dose)
Randomised, double-blind, multi-centre crossover Country: US | Primary endpoint:
|
|
Anifrolumab (type I interferon receptor mAb)
Lupus (SLE / LN)
Patients | Trial | Population | Endpoints | Status | Design |
450 |
|
| Phase III TULIP SLE 1 NCT02446912 | Moderate to severe SLE |
|
|
| Phase III TULIP SLE 2 NCT02446899 |
| 360 | Moderate to severe SLE |
Moderate to severe SLE | 630 |
| Phase III TULIP LTE NCT02794285 |
|
|
Moderate to severe SLE patients |
|
| 307 | Phase ll NCT01438489 |
|
| Moderate to severe SLE patients | Phase II NCT01753193 | 218 |
|
|
|
| 32 | Moderate to severe SLE patients | Phase II NCT02962960 |
|
150 |
|
| Phase II TULIP-LN1 NCT02547922 | Active Proliferative LN |
|
Brazikumab (IL23 inhibitor)
Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Trial | Population | Patients | Design | Endpoints | Status |
Phase IIb / III INTREPID NCT03759288 | Crohn's Disease | 1,140 |
| Primary
Secondary
|
|
Phase III NCT03961815 | Crohn's Disease | 1,000 |
|
|
|
Phase II EXPEDITION NCT03616821 | Ulcerative Colitis | 375 |
| Primary
Secondary
|
|
Phase II NCT04277546 | Ulcerative Colitis | 300 |
|
|
|
Nirsevimab (Respiratory syncytial virus mAb-YTE )
Infection
Trial | Population | Patients | Design | Endpoints | Status |
Phase IIb NCT02878330 | 29-35 WK GA (Gestational age) infants | 1,453 |
|
|
|
Phase II/III MEDLEY NCT03959488 | High risk preterm (born 35 weeks 0 day or less GA), CHD and CLD infants eligible to receive palivizumab | 1,500 |
Global trial - 32 countries |
|
|
Phase III MELODY NCT03979313 | Healthy infants (born 35 weeks 0 days or greater GA) | 3,000 |
Global trial - 31 countries |
|
|
Phase II Japan IC NCT04484935 | Immunocompromised Japanese children who are ≤ 24 months of age at the time of dose administration | 30 |
Japan only |
|
|
AZD1222 (SARS-CoV-2)
Prevention of COVID-19
Trial | Population | Patients | Design | Endpoints | Status |
Phase I/II COV001 (UK) NCT04324606 Partnered | Healthy adults Age 18-55 years | 1,077 | Single-blinded, randomised, controlled, multi-centre trial
UK |
|
|
Phase I/II COV005 (SA) NCT04444674 Partnered | Healthy adults Age 18-65 years HIV+ subgroup | 2,125 | Adaptive, double-blinded, randomised placebo-controlled trial
South Africa |
|
|
Phase II/III COV002 (UK) NCT04400838 Partnered | Main efficacy trial: healthy adults aged ≥18 years Healthy adults 56 - <70 years Healthy adults 70 years Healthy children 5 - 12 years | 10,812 | Single-blinded, randomised, controlled, multi-centre trial with sequential age escalation/de-escalation immunogenicity sub-studies that include prime boost
UK |
|
|
Phase III D8110C00001 (US, global) NCT04516746 | Healthy adults Age 18-65 years | 32,429 | Adaptive, double-blinded, randomised placebo-controlled trial
US, with intent to expand to other countries |
|
|
Phase III COV003 (Brazil) NCT04536051 Partnered | Health professionals and adults with high potential for exposure to SARS-CoV-2 Age 18-55 years | 10,414 | Single-blinded, randomised, controlled multi-centre trial
Brazil |
|
|
Phase III D8111C00001 NCT04540393 | Healthy adults Age ≥18 years | 100 | Open-label, non-comparative trial Russia |
|
|
Phase I/II D8111C00002 NCT04568031 | Healthy adults Age ≥18 years | 256 | Double-blinded, randomised, placebo-controlled multi-centre trial
Japan |
|
|
Phase I/II COV004 (Kenya) | Healthy adults | 400 | Double-blinded, randomised, placebo-controlled multi-centre trial
Kenya |
|
|
AZD7442 (LAAB combination of AZD8895 & AZD1061)
Prevention and treatment of COVID-19
Trial | Population | Patients/Subjects | Design | Endpoints | Status |
Phase I NCT04507256 | Healthy adults Age 18-55 years | 60 | Double-blinded, randomised, placebo controlled, single ascending dose study AZD7442/placebo (10:2) Single center, UK |
|
|
Phase III PROVENT D8850C00002 NCT04625725 | Adults having increased risk for inadequate response to active immunization or having increased risk for SARS-CoV-2 infection | 5,000 | Double-blinded, randomized, placebo controlled, multi center study to determine safety and efficacy AZD7442/placebo (2:1) Pre-exposure Countries: USA, UK, Belgium, France, Spain |
|
|
Phase III STORMCHASER D8850C00003 NCT04625972 | Adults with potential exposure To an identified individual with confirmed SARS-COV2 infection and at risk of developing COVID-19 | 1,125 | Double-blinded, randomized, placebo controlled, multi center study to determine safety and efficacy AZD7442/placebo (2:1) Post-exposure Countries: USA and UK |
|
|
PHASE III TACKLE NCT04723394 | Adults with confirmed mild to moderate SARS-COV2 infection. Symptomatic patients with documented positive SARS-Cov-2 molecular test. | 1,700 | Double-blinded, randomized, placebo controlled, multi center study to determine safety and efficacy of AZD7442 for treatment of Covid-19 in non-hospitalized patients AZD7442/placebo (1:1) Countries: UK, Germany, Spain, Italy, Hungary, Russia, US, Mexico and Japan |
|
|
COVID-19 trials Treatment of COVID-19
Trial | Compound | Population | Patients | Design | Endpoints | Status |
Phase III DARE-19 NCT04350593 | Farxiga | COVID-19 | 1,250 |
|
|
|
Phase II TACTIC-E NCT04393246 | Farxiga | COVID-19 | 1,407 |
|
|
|
Phase IIIa TACTIC-COVID NCT04355637 | Pulmicort | COVID-19 | 300 |
|
|
|
Phase IIIa STOIC NCT04416399 | Pulmicort | COVID-19 | 478 |
|
|
|
Phase IIIa INHASCO NCT04331054 | Symbicort | COVID-19 | 436 |
|
|
|
Phase II ACCORD | MEDI3506 | COVID-19 | 180 |
|
|
|
BioPharmaceuticals - early-stage development
Cotadutide (GLP-1-glucagon agonist)
Diabetes/CKD, NASH
Trial | Population | Patients | Design | Endpoints | Status |
Phase II NCT03555994 | Adults with type-2 diabetes | 44 |
|
|
• Part A LPCD: Q4 2018 • Data readout: Q1 2019 • Part B FPCD: Q1 2020
|
Phase II NCT03596177 | Overweight and obese patients with type-2 diabetes | 27 |
|
|
|
Phase II NCT04019561 | Obese patients with non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) | 72 |
|
|
|
Phase II NCT04515849 | A Study of Cotadutide in participants who have chronic kidney disease with type 2 diabetes mellitus | 225 |
|
|
|
Phase I NCT04091373 | Healthy adult patients | 36 |
|
|
Verinurad (URAT1 inhibitor)
CKD, HFpEF
Trial | Population | Patients | Design | Endpoints | Status |
Phase II NCT03990363 | Patients with:
| 725 |
This trial is multi-centre trial conducted in USA, China, Czech Republic, France, Hungary, Israel, Italy, Mexico, Poland, Romania, Slovakia, South Africa, Spain | Ratio of urinary albumin to urinary creatinine Changes in eGFR, Cystatin C, and uric acid |
|
Phase I NCT03118739 | Healthy volunteers | 24 |
The trial is a single-centre, randomised, placebo-controlled, double-blind, 3-period, cross-over trial conducted in Germany | To assess the effect of a single dose of verinurad given as either a 24 mg extended-release (ER8) formulation (therapeutic exposure) or a 40 mg immediate-release (IR) formulation (supra-therapeutic exposure), both in combination with allopurinol 300 mg, on the QT interval corrected for heart rate using Fridericia's formula (QTcF) compared to placebo |
|
Phase I NCT04532918 | Healthy volunteers | 14 |
Allopurinol under fasted conditions
The trial is a single-centre, randomised, open-label, 3-period, fixed sequence, trial conducted in Germany | To quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor,on verinurad pharmacokinetics (PK). |
|
Phase II NCT04327024 | Patients with heart failure with preserved ejection fraction | 435 |
The trial is a multi-centre trial conducted in Argentina, Australia, Austria, Bulgaria, Canada, Germany, Mexico, Poland, Russia, Slovakia South Korea, USA | Peak V02 Change from baseline at Week 28 in exercise capacity Change from baseline at Week 28 in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) |
|
AZD2373
Chronic kidney disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04269031 | Healthy volunteers | 48 | SAD Dose escalation in 6 cohorts with 6 volunteers receiving AZD2373 and 2 volunteers receiving placebo in each cohort Trial conducted in the US | Primary:
Secondary;
|
|
AZD2693 (resolution of NASH)
NASH
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04142424 | Healthy volunteers | 48 | SAD 6 cohorts with 6 volunteers receiving AZD2693 and 2 volunteers receiving placebo in each cohort Route of administration: subcutaneous injections Trial conducted in the US. | Primary:
Secondary;
|
|
Phase I NCT04142424 | NAFLD F0-F3 | 60 | MAD 3 cohorts receiving AZD2693 and placebo in each cohort Route of administration: subcutaneous injections Trial conducted in the US. | Primary:
Secondary;
|
|
AZD3427 (relaxin)
Heart failure
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04630067 | SAD - Healthy Volunteers MAD - Heart Failure | 96 |
| Safety & Tolerability |
|
AZD3366 Cardiovascular disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04588727 | Healthy volunteers | 87 | SAD Part A Dose escalation in 6 cohorts with 6 volunteers receiving AZD3366 and 2 volunteers receiving placebo in each cohort Part B 12 subjects receiving AZD3366 and ticagrelor and ASA Trial conducted in the US | Primary:
Secondary;
|
|
MEDI3506 (IL33 ligand mAb)
Diabetic kidney disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase II NCT04170543 | Adult patients with diabetic kidney disease | 565 |
This trial is multi-centre trial conducted in USA, Canada, Japan and additional countries. |
|
|
AZD4831 (MPO inhibitor)
Cardiovascular disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT02712372 | Healthy patients | c. 96 | SAD trial (one trial site in Germany)
|
|
|
Phase I NCT03136991 | Healthy patients | c. 40 | MAD (one trial site in USA)
|
|
|
Phase IIa NCT03756285 | HFpEF | 96 | Arm 1: AZD4831 Arm 2: placebo Global trial - five countries |
|
|
Phase I NCT04232345 | Healthy patients | 32 | SAD trial in Japanese and Chinese patients |
|
|
AZD5718 (FLAP inhibitor)
Cardiovascular disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase IIa NCT03317002 | CAD | 129 |
Global trial - three countries in Europe |
|
|
Phase I NCT03948451 | Healthy patients | 6 | hADME trial (one trial site in UK)
Open-label trial to characterize the absorption, distribution, metabolism and excretion following a single oral dose of [14C]AZD5718 in healthy male volunteers |
|
|
Phase I NCT04087187 | Healthy patients | 14 | BA trial (one trial site in UK) An open-label, randomized, 3-period, 3-treatment, crossover trial to assess the drug absorption into the blood after administration of 3 doses of AZD5718 |
|
|
Phase I NCT04210388 | Healthy patients | 12 | BA trial (one trial site in UK) The trial is a randomized, single-dose, open-label, combined 2x2 dose and 3x3 dose crossover design in fixed sequence. | To evaluate:
|
|
Phase IIb NCT04492722 | CKD | 632 | Interventional A Phase IIb randomised, double-blind, placebo-controlled, multi-centre, dose-ranging trial of AZD5718 in participants with proteinuric CKD | To evaluate:
|
|
AZD8233 (PCSK9 inhibitor, sub-cutaneious)
Dyslipidemia
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03593785 | Healthy subjects | 72 | SAD 7 cohorts with 6 subjects receiving AZD8233 and 2 subjects receiving placebo in each cohort Trial conducted in the US. | Primary:
Secondary;
|
|
Phase I NCT04155645 | Dyslipidemia | 33 | MAD Up to 3 cohorts with 8 subjects receiving AZD8233 and 3 subjects receiving placebo in each cohort Trial conducted in the US | Primary:
Secondary;
|
|
Phase II NCT04641299 | Dyslipidemia | 108 | Subjects are randomized across four different treatment arms in a 1:1:1:1 ratio for a 12-week treatment period Arm 1: High AZD8233 dose Arm 2: Medium AZD8233 dose Arm 3: Low AZD8233 dose Arm 4: placebo Trial conducted in 3 countries (US, Slovakia and Denmark) | Primary:
|
|
MEDI8367
Chronic kidney disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT04365218 | Healthy volunteers CKD | 70 | Single ascending dose 6 cohorts Arm 1: MEDI8367 Arm 2: placebo Subcutaneous administration Trial conducted in the US | Primary:
Secondary;
|
|
AZD8601 (VEGF-A modified RNA)
Cardiovascular disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT02935712 | Type 2 diabetic patients | c. 60 | SAD trial (one trial site in Germany)
|
|
|
Phase IIa NCTT03370887 | HF | Up to 33 | Phase IIa trial (two trial sites in Finland, two in Germany)
|
|
|
AZD9977 Heart failure
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03435276 | Healthy volunteers | 27 | MAD Dose escalation in 3 cohorts with 6 subjects receiving AZD9977 and 3 volunteers receiving placebo in each cohort Trial conducted in the UK. | Primary:
Secondary;
|
|
Phase I NCT03450759 | Healthy volunteers | 12 | Bioavailability trial Investigation of four different oral formulations of AZD9977 and influence of food. Trial conducted in the UK. | Primary:
|
|
Phase I NCT03682497 | HF | 60 | Proof of differentiation To compare the effect of AZD9977 with spironolactone on serum potassium | Primary:
|
|
Phase I NCT03843060 | Healthy volunteers | 14 | DDI To assess the effect of itraconazole on the pharmacokinetics of AZD9977 Trial conducted in the US | Primary:
Secondary;
|
|
Phase I NCT03801967 | Healthy volunteers | 45 | JSMAD Single and multiple-ascending dose administration in Japanese healthy volunteers. Trial conducted in the UK | Primary:
Secondary;
|
|
Phase I NCT03804645 | Healthy volunteers | 12 | Bioavailability trial Investigation of four different oral formulations of AZD9977 and influence of food. Trial conducted in the UK | Primary:
|
|
Phase I NCT04469907 | Renal Impairment | 32 | Renal Impairment Single dose administration of AZD9977 conducted in participants with severe renal impairment and compared with matched participants with normal renal function Trial conducted in the US | Primary:
Secondary:
|
|
Phase I NCT04686591 | Healthy volunteers | 8 | ADME Study of absorption-distribution-metabolism-excretion (ADME) of 14C-AZD9977 following a single oral dose and absolute bioavailability of a single oral dose with respect to AZD9977 Trial conducted in the UK | Primary:
Secondary:
|
|
Zibotentan (endothelin receptor antagonist)
Chronic kidney disease
Trial | Population | Patients | Design | Endpoints | Status |
Phase IIb NCT04724837 | Chronic Kidney Disease | 660 | Global recruitment Part A: 132 participants equally randomised across 4 arms: Arm 1: Zibotentan dose A + Dapagliflozin 10 mg once daily. Arm 2: Zibotentan dose A once daily. Arm 3: Dapagliflozin 10 mg once daily. Arm 4: Placebo once daily. Part B: 528 participants equally randomised across 6 arms: Arm 1: Zibotentan dose C + Dapagliflozin 10 mg once daily. Arm 2: Zibotentan dose B + Dapagliflozin 10 mg once daily. Arm 3: Zibotentan dose A + Dapagliflozin 10 mg once daily. Arm 4: Zibotentan dose A once daily. Arm 5: Dapagliflozin 10 mg once daily. Arm 6: Placebo once daily. | Primary Endpoint: Change in log-transformed UACR from baseline to week 12. Secondary Endpoints: •Change in log-transformed UACR from baseline to week 12. •Change in blood pressure from baseline (Visit 2) to week 12. •The least squares mean change of UACR at week 12 from the 3 Zibo/Dapa dose groups and the dapagliflozin monotherapy group. •Change in eGFR from baseline to week 1, week 12 and week 14. •Change in eGFR from week 1 to week 12. |
|
Biologics
Cardiovascular & metabolic diseases
Trial | Compound | Population | Patients | Design | Endpoints | Status |
Phase IIb EudraCT 2017-004521-32 | MEDI6012 rhLCAT | Subjects 30-80 years of age inclusive, presenting with acute STEMI | 595 |
| Primary endpoints: Infarct size as a percentage of left ventricle (LV) mass at 10-12 weeks post-MI (myocardial infarction) compared to placebo Secondary endpoints:
|
|
Phase IIa NCT03351738 | MEDI5884 cholesterol modulation | Adults with stable CHD | 133 |
|
|
|
Phase I NCT03654313 | MEDI6570 | Atherosclerotic cardiovascular disease | 88 |
|
|
|
Phase IIb NCT04610892 | MEDI6570 | Post MI | 792 | Evaluation of anti-inflammatory potential of MEDI6570 and its effect on surrogates for atherosclerotic and heart failure (HF) events . Subjects are randomized across four different treatment arms in a 1:1:1:1 ratio Arm 1: High AZD6570 dose Arm 2: Medium AZD6570 dose Arm 3: Low AZD6570 dose Arm 4: Placebo Trial conducted in 9 countries (US, Canada, Hungary, Japan, Czech Republic, Italy, Spain, Netherlands, Poland,) |
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AZD0449 (inhaled JAK-1 inhibitor)
Asthma
Trial | Population | Patients | Design | Endpoints | Status |
Phase I NCT03766399 | Healthy subjects and patients with mild asthma | 156 | SAD/MAD/Bridge trial (UK) Part 1 SAD
Part 2 MAD:
Part 3 bridge
Trial conducted in the UK | Primary endpoint:
Secondary endpoint:
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|
AZD1402 (IL4 receptor alpha antagonist)
Asthma
Trial | Population | Patients | Design | Endpoints | Status |
Phase Ib NCT03574805 Partnered | Patients with mild asthma | 84 | PoM. A dose-escalating, single blind trial to assess the safety, tolerability, and pharmacokinetics of multiple doses of PRS-060 administered by oral Inhalation In subjects with mild asthma Australia | Primary endpoint:
Secondary endpoint:
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|
100
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AstraZeneca plc published this content on 11 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 February 2021 09:34:05 UTC.
