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
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.
Detailed 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.
Arms & 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
Outcome measures
Primary
ORR (per RECIST 1.1 as assessed by Investigator)
the proportion of participants who have a confirmed complete response or confirmed partial response, as determined by the Investigator at local site per RECIST 1.1.
Time frame: Through substudy completion, an average of 2 years
PFS6 (per RECIST 1.1 as assessed by Investigator)
the proportion of participants alive and progression-free at 6 months.
Time frame: Through substudy completion, an average of 2 years
Secondary
PFS per RECIST 1.1 as assessed by the Investigator
Time frame: Through substudy completion, an average of 2 years
OS
Time frame: Through substudy completion, an average of 2 years
other safety related endpoints
Time frame: Through substudy completion, an average of 2 years
DoR per RECIST 1.1 based on Investigator assessment.
Time frame: Through substudy completion, an average of 2 years
Eligibility criteria
Study locations (11)
Research Site
Los Angeles, California, 90017
Research Site
Los Angeles, California, 90095
Research Site
Baton Rouge, Louisiana, 70817
Research Site
Grand Rapids, Michigan, 49503
Research Site
New Hyde Park, New York, 11042
Research Site
New York, New York, 10028
Research Site
New York, New York, 10065
Research Site
New York, New York, 11210
Research Site
Shirley, New York, 11967
Research Site
The Bronx, New York, 10469
Research Site
Pittsburgh, Pennsylvania, 15212