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Clinical Trials in the UK / NCT05702229
Recruiting Phase 2

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

NCT05702229 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2023-01-16
Last updated
2026-05-14

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

RilvegostomigVolrustomigFOLFOXXELOXAZD09015-FluorouracilCapecitabine

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Research Site Los Angeles California Recruiting
Research Site Los Angeles California Withdrawn
Research Site Baton Rouge Louisiana Recruiting
Research Site Grand Rapids Michigan Recruiting
Research Site New Hyde Park New York Withdrawn
Research Site New York New York Withdrawn
Research Site New York New York Recruiting
Research Site New York New York Withdrawn
Research Site Shirley New York Withdrawn
Research Site The Bronx New York Withdrawn
Research Site Pittsburgh Pennsylvania Withdrawn
Research Site Beijing China Recruiting
Research Site Hangzhou China Recruiting
Research Site Hangzhou China Recruiting
Research Site Harbin China Recruiting
Research Site Hefei China Recruiting
Research Site Kunming China Completed
Research Site Wuhan China Recruiting
Research Site Yinchuan China Recruiting
Research Site Zhengzhou China Recruiting
Research Site Chūōku Japan Recruiting
Research Site Kashiwa Japan Recruiting
Research Site Sunto-gun Japan Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Barcelona Spain Recruiting
Research Site Elche(Alicante) Spain Recruiting
Research Site L'Hospitalet de Llobregat Spain Recruiting
Research Site Madrid Spain Recruiting
Research Site Madrid Spain Recruiting
Research Site Santander Spain Recruiting
Research Site Hsinchu Taiwan Recruiting
Research Site Kaohsiung City Taiwan Recruiting
Research Site Taichung Taiwan Recruiting
Research Site Tainan Taiwan Recruiting
Research Site Taipei Taiwan Recruiting
Research Site Taipei Taiwan Recruiting
Research Site Taoyuan Taiwan Recruiting

+ 4 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05702229 on ClinicalTrials.gov ↗ ← All trials in the UK