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Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

NCT05702229•AstraZeneca

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (44)

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Baton Rouge, Louisiana, United States

Research Site

Grand Rapids, Michigan, United States

Research Site

New Hyde Park, New York, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Shirley, New York, United States

Research Site

The Bronx, New York, United States

Key Dates

Start Date

January 16, 2023

Primary Completion Date

November 30, 2027

Completion Date

May 31, 2029

Last Updated

March 18, 2026

Enrollment

163

ESTIMATED participants

Conditions

Gastric Cancer

Interventions

Rilvegostomig

DRUG

Volrustomig

DRUG

FOLFOX

DRUG

XELOX

DRUG

AZD0901

DRUG

5-Fluorouracil

DRUG

Capecitabine

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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