NCT07143604

A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2

A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

Detailed description

This is a Phase II, single arm, open label, multicentre study, assessing the efficacy and safety of AZD0901 in participants with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. The results of the study will provide clinical data on efficacy and safety of an innovation drug in Russian Federation.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
DRUG	AZD0901	Participants will receive AZD0901 IV, Q3W

Timeline

• Start date: 2025-08-29
• Primary completion: 2026-09-28
• Completion: 2027-09-28
• First posted: 2025-08-27
• Last updated: 2026-03-17

Locations

13 sites across 1 country: Russia