Study identifier:D7986C00001
ClinicalTrials.gov identifier:NCT05702229
EudraCT identifier:2022-002840-29
CTIS identifier:2024-510977-27-00
An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
gastric cancer
Phase 2
No
Rilvegostomig, Volrustomig, FOLFOX, XELOX, AZD0901, 5-Fluorouracil, Capecitabine
All
163
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2026 by AstraZeneca
AstraZeneca
-
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Substudy 1 Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) | 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 |
| Experimental: Substudy 2 Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) | Drug: Rilvegostomig an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion Drug: FOLFOX 5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available) Drug: XELOX capecitabine and oxaliplatin |
| Experimental: Substudy 3 AZD0901 plus volrustomig and 5-fluorouracil or capecitabine | Drug: Volrustomig an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: 5-Fluorouracil 5-FU, IV infusion Drug: Capecitabine Oral take |
| Experimental: Substudy 4, Cohort 4a1 Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine | Drug: Rilvegostomig an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: 5-Fluorouracil 5-FU, IV infusion Drug: Capecitabine Oral take |
| Experimental: Substudy 4, Cohort 4a2 Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil | Drug: Rilvegostomig an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: 5-Fluorouracil 5-FU, IV infusion |
| Experimental: Substudy 4, Cohort 4b Sonesitatug vedotin (AZD0901) plus capecitabine | Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: Capecitabine Oral take |