AstraZeneca
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.
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.
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…
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
capecitabine and oxaliplatin
an anti Claudin18.2 ADC; IV infusion
5-FU, IV infusion
Oral take