Back to Trials
NCT05702229PHASE2Recruiting

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

AstraZeneca

Start Date

1/16/2023

Completion Date

5/31/2029

Summary

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Detailed Description

Approximately 360 participants will be assigned across 4 substudies, with approximately 60 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy/cohort.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 18 years or older at the time of signing the ICF. * Body weight \> 35 kg. * Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. * Has measurable target disease assessed by the Investigator based on RECIST 1.1. * ECOG PS zero or one. * Life expectancy of at least 12 weeks. * Adequate organ and bone marrow function. * Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 i s open for recruitment. Exclusion Criteria: * Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma. * Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression. * Participants with ascites which cannot be controlled with appropriate interventions. * Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C. * Uncontrolled intercurrent illness. * Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment. * History of another primary malignancy. * Previous treatment with an immune-oncology agent. * Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4 is open for recruitment).

Interventions

DRUG

Rilvegostomig

DRUG

Volrustomig

DRUG

FOLFOX

DRUG

XELOX

DRUG

AZD0901

DRUG

5-Fluorouracil

DRUG

Capecitabine

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Gastric Cancer

Locations

Research Site

Los Angeles, California 90017

United States

Research Site

Los Angeles, California 90095

United States

Research Site

Baton Rouge, Louisiana 70817

United States

Research Site

Grand Rapids, Michigan 49503

United States

Research Site

New Hyde Park, New York 11042

United States

Research Site

New York, New York 10028

United States

Research Site

New York, New York 10065

United States

Research Site

New York, New York 11210

United States

Research Site

Shirley, New York 11967

United States

Research Site

The Bronx, New York 10469

United States

Research Site

Pittsburgh, Pennsylvania 15212

United States

Research Site

Beijing, 100142

China

Research Site

Hangzhou, 310003

China

Research Site

Hangzhou, 310020

China

Research Site

Harbin, 150081

China

Research Site

Hefei, 230031

China

Research Site

Kunming, 650118

China

Research Site

Wuhan, 430079

China

Research Site

Yinchuan, 750004

China

Research Site

Zhengzhou, 450052

China

Research Site

Chūōku, 104-0045

Japan

Research Site

Kashiwa, 227-8577

Japan

Research Site

Sunto-gun, 411-8777

Japan

Research Site

Seoul, 03080

South Korea

Research Site

Seoul, 03722

South Korea

Research Site

Seoul, 05505

South Korea

Research Site

Seoul, 06351

South Korea

Research Site

Barcelona, 08035

Spain

Research Site

Elche(Alicante), 03202

Spain

Research Site

L'Hospitalet de Llobregat, 08908

Spain

Research Site

Madrid, 28007

Spain

Research Site

Madrid, 28040

Spain

Research Site

Santander, 39008

Spain

Research Site

Hsinchu, 300

Taiwan

Research Site

Kaohsiung City, 80756

Taiwan

Research Site

Taichung, 404

Taiwan

Research Site

Tainan, 70403

Taiwan

Research Site

Taipei, 10002

Taiwan

Research Site

Taipei, 11259

Taiwan

Research Site

Taoyuan, 333

Taiwan

Research Site

Edinburgh, EH4 2XU

United Kingdom

Research Site

Leeds, LS9 7TF

United Kingdom

Research Site

London, EC1M 6BQ

United Kingdom

Research Site

Oxford, OX3 7LE

United Kingdom