Recruiting
Phase 2

Novel Combinations

Sponsor:

AstraZeneca

Code:

NCT05702229

Conditions

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rilvegostomig

Volrustomig

FOLFOX

XELOX

AZD0901

Study Details

Brief 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.

Conditions

Gastric Cancer

Study ID

NCT05702229

Start date

Jan 16, 2023

Status verified date

May, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

163 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Substudy 1

Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

experimental: Substudy 2

Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

experimental: Substudy 3

AZD0901 plus volrustomig and 5-fluorouracil or capecitabine

experimental: Substudy 4, Cohort 4a1

Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine

experimental: Substudy 4, Cohort 4a2

Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil

experimental: Substudy 4, Cohort 4b

Sonesitatug vedotin (AZD0901) plus capecitabine

Interventions

Rilvegostomig

an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion

Volrustomig

an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion

FOLFOX

5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)

XELOX

capecitabine and oxaliplatin

AZD0901

an anti Claudin18.2 ADC; IV infusion

5-Fluorouracil

5-FU, IV infusion

Capecitabine

Oral take

Primary outcome measure

  • ORR (per RECIST 1.1 as assessed by Investigator) [ Time Frame: Through substudy completion, an average of 2 years ]
  • PFS6 (per RECIST 1.1 as assessed by Investigator) [ Time Frame: Through substudy completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Los Angeles, California, United States, 90017

Research Site

Recruiting

Baton Rouge, Louisiana, United States, 70817

Research Site

Recruiting

Grand Rapids, Michigan, United States, 49503

Research Site

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

AstraZeneca

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Locally advanced
  • Metatstatic
  • Gastric adenocarcinoma
  • GEJ adenocarcinoma
  • GEMINI-Gastric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-05-14.