Novel combinations in participants with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Study identifier:D7986C00001
ClinicalTrials.gov identifier:NCT05702229
EudraCT identifier:2022-002840-29
CTIS identifier:2024-510977-27-00
Recruiting
Official Title
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
Medical condition
gastric cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
Rilvegostomig, Volrustomig, FOLFOX, XELOX, AZD7789, AZD0901, 5-Fluorouracil, Capecitabine
Sex
All
Estimated Enrollment
240
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 16 Jan 2023
Estimated Primary Completion Date: 30 Jan 2026
Estimated Study Completion Date: 28 Jan 2027
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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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 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2 Drug: XELOX capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1 |
| 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 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2 Drug: XELOX capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1 |
| 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, Q3W Drug: Capecitabine Oral take, Q3W |
| Experimental: Substudy 4 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, Q3W Drug: Capecitabine Oral take, Q3W |
| Experimental: Substudy 5 AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) | Drug: FOLFOX 5-fluorouracil 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2 Drug: XELOX capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1 Drug: AZD7789 an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion |
| Experimental: Substudy 6 AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine | Drug: AZD7789 an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: 5-Fluorouracil 5-FU, IV infusion, Q3W Drug: Capecitabine Oral take, Q3W |
