The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well.
This study is a multicenter, open label, phase Ⅰb/Ⅱ clinical study conducted in unresectable patients with advanced or recurrent metastatic Claudin18.2 positive (medium and high expression) and HER-2 negative primary gastric adenocarcinoma or gastric esophageal junction adenocarcinoma. The Phase Ib dose escalation study included two dose groups each combined with the XELOX standard treatment regimen. Perform dose escalation to obtain MTD and/or RP2D doses for combined administration. The Phase II study adopted an open label parallel randomized controlled design. Further observe the efficacy and safety of Q-1802 combined with XELOX regimen in treating patients with moderate to high expression of Claudin 18.2, and compare and analyze the efficacy and safety of Q-1802 combined with XELOX regimen and XELOX regimen alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Q-1802:A dose Q-1802 will be administered intravenously Q2W. XELOX(oxaliplatin,capecitabin): 21 days as a cycle Oxaliplatin will be administered 130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one cycle.
Beijing cancer hospical
Beijing, Beijing Municipality, China
RECRUITINGNumber of participants with treatment-related adverse events(TRAE)
TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802
Time frame: From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months
Objective response rate (ORR)
ORR is defined as proportion of participants with complete response, partial response (CR+PR).
Time frame: From the first dose of study drug administration up to 6 months after the last pts in,up to19 months
Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
Time frame: From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.