Back to search results

Study of New Drug Combinations for Gastric or GEJ Adenocarcinoma

This study is looking at new combinations of medicines for people with locally advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma. The medicines being tested include Rilvegostomig, Volrustomig, FOLFOX, XELOX, and AZD0901. You might be able to join if you are 18 or older, have not been treated for this type of cancer before, and meet other health requirements. The researchers want to see how well these combinations shrink tumors and how long people live without their cancer getting worse. The study is currently recruiting about 163 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves multiple drugs and centers, aiming to enroll about 163 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well treatments work and how long people live without their cancer getting worse for an average of 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05702229

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~163 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:RilvegostomigVolrustomigFOLFOXXELOXAZD09015-Fluorouracil

At a glance

Recruiting sites
35 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ORR (per RECIST 1.1 as assessed by Investigator)
Measured over Through substudy completion, an average of 2 years
+1 more outcome measured

Conditions

Gastric Cancer

Explore related trials

Gastric CarcinomaGastroesophageal Junction Adenocarcinoma

Where it's being run

44 sites across 11 states
China9
Taiwan7
New York6
Spain6
South Korea4
United Kingdom4
Japan3
California2

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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).

What this trial measures

  • ORR (per RECIST 1.1 as assessed by Investigator)Through substudy completion, an average of 2 years

    the proportion of participants who have a confirmed complete response or confirmed partial response, as determined by the Investigator at local site per RECIST 1.1.

  • PFS6 (per RECIST 1.1 as assessed by Investigator)Through substudy completion, an average of 2 years

    the proportion of participants alive and progression-free at 6 months.