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AZD4360

Phase 1

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

AZD4360 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

AZD4360 clinical trials

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD4360 MonotherapyEXPERIMENTALAZD4360 Monotherapy

Interventions

NameTypeDescription
AZD4360DRUGAntibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
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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
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Recent Changes (Last 90 Days)

HIGHJul 31, 2026NCT06921928Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 31, 2026NCT06921928Status: RECRUITING → ACTIVE_NOT_RECRUITING

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.