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 240 participants will be assigned across 6 substudies, with approximately 40 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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 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
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
PFS per RECIST 1.1 as assessed by the Investigator
the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression.
Time frame: Through substudy completion, an average of 2 years
OS
the time from the start of study intervention until the date of death due to any cause.
Time frame: Through substudy completion, an average of 2 years
other safety related endpoints
Incidence of AEs, AESIs, and SAEs.
Time frame: Through substudy completion, an average of 2 years
DoR per RECIST 1.1 based on Investigator assessment.
the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression.
Time frame: Through substudy completion, an average of 2 years
AstraZeneca Clinical Study Information Center
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capecitabine 1000 mg/m\^2 BID, days 1 to 14, oxaliplatin 130 mg/m\^2, day 1
an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion
an anti Claudin18.2 ADC; IV infusion
5-FU, IV infusion, Q3W
Oral take, Q3W
Research Site
Los Angeles, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
WITHDRAWNResearch Site
Baton Rouge, Louisiana, United States
RECRUITINGResearch Site
Grand Rapids, Michigan, United States
RECRUITINGResearch Site
New Hyde Park, New York, United States
WITHDRAWNResearch Site
New York, New York, United States
WITHDRAWNResearch Site
New York, New York, United States
RECRUITINGResearch Site
New York, New York, United States
WITHDRAWNResearch Site
Shirley, New York, United States
WITHDRAWNResearch Site
The Bronx, New York, United States
WITHDRAWN...and 34 more locations