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:N/A
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
AZD2936, MEDI5752, FOLFOX, XELOX
Sex
All
Estimated Enrollment
80
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 16 Jan 2023
Estimated Primary Completion Date: 15 Aug 2025
Estimated Study Completion Date: 15 Feb 2026
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Substudy 1 MEDI5752 Plus XELOX/FOLFOX | Drug: MEDI5752 a PD-1 and 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 AZD2936 Plus XELOX/FOLFOX | Drug: AZD2936 a PD-1 and 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 |
