NCT06346392

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

A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator's Choice of Therapy in Second- or Later-Line Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY Gastric 01)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 572 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase III, multi-center, open-label, sponsor-blinded, randomized, global study to assess the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as the 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2, and the clinical performance of the investigational IVD. As part of this combined approach, the efficacy analyses from this study will also provide the basis to evaluate the clinical performance of Ventana CLDN18.2 assay as an IVD device for the identification of patients with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2 who may benefit from AZD0901.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-03-04
• Primary completion: 2026-05-14
• Completion: 2026-09-14
• First posted: 2024-04-04
• Last updated: 2026-03-09

Locations

186 sites across 19 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

Regulatory

• FDA-regulated drug study