NCT05702229 · AstraZeneca
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
What this study is about
This is a Phase II, where both patients and doctors know the treatment given, multi-drug, multi-centre study designed to assess the effectiveness, safety, tolerability, how the drug moves through the body, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
View original scientific description
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.
Interventions
DRUG
Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
DRUG
Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
DRUG
FOLFOX
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
DRUG
XELOX
capecitabine and oxaliplatin
DRUG
AZD0901
an anti Claudin18.2 ADC; IV infusion
DRUG
5-Fluorouracil
5-FU, IV infusion
DRUG
Capecitabine
Oral take
Primary outcome measures
ORR (per RECIST 1.1 as assessed by Investigator)
Time frame: 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)
Time frame: Through substudy completion, an average of 2 years
the proportion of participants alive and progression-free at 6 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 or Substudy 6 is 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, HI
Where
- Los Angeles, California
- Baton Rouge, Louisiana
- Grand Rapids, Michigan
- New Hyde Park, New York
- New York, New York
- Shirley, New York
- The Bronx, New York
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations