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New treatment combinations for advanced gastric cancer

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

PHASE2 · AstraZeneca · NCT05702229

This study is testing different combinations of new treatments for people with advanced stomach cancer to see which one works best.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment163 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Locations44 sites (Los Angeles, California and 43 other locations)
Trial IDNCT05702229 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label study evaluates the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Approximately 240 participants will be enrolled across six substudies, with each substudy focusing on a specific combination therapy. Participants will receive treatments such as Rilvegostomig, Volrustomig, FOLFOX, XELOX, and AZD7789, with the goal of determining the most effective regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with untreated unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Not a fit: Patients with HER2-positive gastric or GEJ carcinoma or those with untreated CNS metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promise with combination therapies in gastric cancer, but this specific approach is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Los Angeles, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Gastric Cancer, Locally advanced, Metatstatic, Gastric adenocarcinoma, GEJ adenocarcinoma, GEMINI-Gastric

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.