RecruitingPhase 1Phase 2NCT06921928

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


Sponsor

AstraZeneca

Enrollment

117 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD4360 for people with advanced pancreatic cancer, stomach cancer, or bile duct cancer whose tumors have a protein called Claudin 18.2 on their surface. This is an early-phase dose-finding study to evaluate safety and early effectiveness. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic pancreatic ductal adenocarcinoma, gastric/gastroesophageal junction cancer, or biliary tract cancer - Your tumor tests positive for Claudin 18.2 expression - You have received at least one prior round of chemotherapy - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have not received any prior treatment - Your tumor does not express Claudin 18.2 - You have received prior RAS-targeted therapy (for some study arms) - You are pregnant or breastfeeding - You cannot swallow tablets Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD4360

Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)


Locations(18)

Research Site

Santa Monica, California, United States

Research Site

Providence, Rhode Island, United States

Research Site

Houston, Texas, United States

Research Site

Beijing, China

Research Site

Chengdu, China

Research Site

Shanghai, China

Research Site

Wuhan, China

Research Site

Berlin, Germany

Research Site

Dresden, Germany

Research Site

Frankfurt, Germany

Research Site

Chūōku, Japan

Research Site

Kashiwa, Japan

Research Site

Kōtoku, Japan

Research Site

Sendai, Japan

Research Site

Glasgow, United Kingdom

Research Site

Leeds, United Kingdom

Research Site

London, United Kingdom

Research Site

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06921928


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