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AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

NCT06346392 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2026-03-09

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

AZD0901

Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV

DRUG

AZD0901

Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)

DRUG

Ramucirumab+ paclitaxel

Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)

DRUG

Docetaxel

Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)

DRUG

Irinotecan

Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W

DRUG

TAS-102

TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China)

DRUG

Apatinib

Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-05-14
Completion
2026-09-14
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06346392 on ClinicalTrials.gov