Study for AZD4360 in Participants With Advanced Solid Tumours
A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours
2 other identifiers
interventional
117
5 countries
18
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 gastric-cancer
Started Apr 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedStudy Start
First participant enrolled
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 16, 2027
April 23, 2026
April 1, 2026
1.9 years
March 25, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
Through study completion, up to approximately 2 years
Secondary Outcomes (11)
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
Progression Free Survival (PFS)
Through study completion, up to approximately 2 years
Overall Survival (OS)
Through study completion, up to approximately 2 years
- +6 more secondary outcomes
Study Arms (1)
AZD4360 Monotherapy
EXPERIMENTALAZD4360 Monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Participant must be ≥ 18 at the time of signing the ICF.
- 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.
- Minimum life expectancy of 12 weeks in the opinion of the Investigator.
- Adequate organ and marrow function, as defined by protocol.
- \. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
- \. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.
- \. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.
- \. At least one measurable lesion according to RECIST v1.1.
You may not qualify if:
- Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
- Participants with clinically significant ascites that require drainage.
- Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
- With spinal cord compression or with high risk of paralysis.
- History of non-infectious interstitial lung disease/pneumonitis.
- Participant has cardiac abnormalities, as defined by protocol.
- History of another primary malignancy within 2 years prior to screening.
- Known serologic status reflecting active hepatitis B or hepatitis C.
- Known HIV infection that is not well controlled.
- Active tuberculosis infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Santa Monica, California, 90404, United States
Research Site
Providence, Rhode Island, 02903, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Beijing, 100730, China
Research Site
Chengdu, 610041, China
Research Site
Shanghai, 201318, China
Research Site
Wuhan, 430040, China
Research Site
Berlin, 12200, Germany
Research Site
Dresden, 01307, Germany
Research Site
Frankfurt, 60488, Germany
Research Site
Chūōku, 104-0045, Japan
Research Site
Kashiwa, 227-8577, Japan
Research Site
Kōtoku, 135-8550, Japan
Research Site
Sendai, 980-8574, Japan
Research Site
Glasgow, G12 0YN, United Kingdom
Research Site
Leeds, LS9 7TF, United Kingdom
Research Site
London, EC1A 7BE, United Kingdom
Research Site
Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2025
First Posted
April 10, 2025
Study Start
April 29, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
December 16, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.