Recent Updates
Recently added Catalysts

AZD4360

Phase 1

Gastric Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 31, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

AZD4360 · 1 trial · 4 indications

Phase 1 1
NCT06921928Study for AZD4360 in Participants With Advanced Solid TumoursGastric Cancer
ACTIVE NOT_RECRUITING31 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study for AZD4360 in Participants With Advanced Solid Tumours
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
Through study completion, up to approximately 2 years

To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and/or a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.

Secondary Endpoints

Objective Response Rate (ORR)
Through study completion, up to approximately 2 years
Duration of Response (DoR)
Through study completion, up to approximately 2 years
Disease Control Rate (DCR)
Through study completion, up to approximately 2 years
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD4360 MonotherapyEXPERIMENTALAZD4360 Monotherapy

Interventions

NameTypeDescription
AZD4360DRUGAntibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Participant must be ≥ 18 at the time of signing the ICF. 2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. 3. Minimum life expectancy of 12 weeks in the opinion of the Inve...

Countries:United StatesChinaGermanyJapanUnited Kingdom
Unlock Eligibility Criteria

Competitive Landscape -Gastric Cancer 112 trials

Top 20 of 45 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab, paclitaxel, Paclitaxel, Docetaxel
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY6PHASE2Pumitamig, Folfox, Capox, Nivolumab
Pfizer Inc.PFE7PHASE2disitamab vedotin, tucatinib
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography/Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106- Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed/m2, Cisplatin/m2
Incyte CorporationINCY1PHASE2Capecitabine, Oxaliplatin, Retifanlimab
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
Enliven Therapeutics, Inc.ELVN1PHASE1ELVN-002, Trastuzumab, 5-Fluorouracil, Oxaliplatin, Capecitabine
Unlock Competitive Intelligence

Recent Changes (Last 90 Days)

HIGHJul 31, 2026NCT06921928Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 31, 2026NCT06921928Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 16, 2026NCT06921928lastUpdatePostDate: changed
LOWJun 16, 2026NCT06921928lastUpdatePostDate: changed
LOWJun 16, 2026NCT06921928lastUpdatePostDate: changed

Frequently asked questions about AZD4360

What is AZD4360 used for in gastric cancer?

AZD4360 is an investigational small molecule being studied for the treatment of gastric cancer, as well as gastroesophageal junction cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes AZD4360?

AZD4360 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for advanced solid tumors.

What phase is AZD4360 in?

AZD4360 is in Phase 1 clinical development. It is an investigational drug being studied in a single active clinical trial for advanced solid tumors, including gastric cancer. The drug has not yet been approved and remains under clinical investigation.

What clinical trials is AZD4360 in?

AZD4360 is being studied in one clinical trial with the identifier NCT06921928, titled "Study for AZD4360 in Participants With Advanced Solid Tumours." This Phase 1 trial is active but not recruiting, with an enrollment of 31 participants across the United States, China, Germany, Japan, and the United Kingdom.

Is AZD4360 FDA approved?

AZD4360 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for advanced solid tumors, including gastric cancer. The drug is still in clinical development and has not received regulatory approval.