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
AstraZeneca
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.
Description
Approximately 360 participants will be assigned across 4 substudies, with approximately 60 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy/cohort.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugRilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
- DrugVolrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
- DrugFOLFOX
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
- DrugXELOX
capecitabine and oxaliplatin
- DrugAZD0901
an anti Claudin18.2 ADC; IV infusion
- Drug5-Fluorouracil
5-FU, IV infusion
- DrugCapecitabine
Oral take
Locations (44)
- Research SiteLos Angeles, California
- Research SiteLos Angeles, California
- Research SiteBaton Rouge, Louisiana
- Research SiteGrand Rapids, Michigan
- Research SiteNew Hyde Park, New York
- Research SiteNew York, New York