Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT05702229 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163
Last updated 2026-05-14
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
Interventions
- DRUG
-
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
-
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-FU, IV infusion
- DRUG
-
Oral take
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-16
- Primary Completion
- 2027-11-30
- Completion
- 2029-05-31
- FDA Drug
- Yes
Countries
- United States
- China
- Japan
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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