A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer

This is a multicenter, randomized, open-label, two-stage Phase IIb clinical study to evaluate the efficacy and safety of B1962 in the treatment of advanced colorectal cancer. The subjects were patients with distant metastasis or unresectable locally advanced colorectal cancer who had previously failed oxaliplatin, irinotecan, fluorouracil-based drugs therapy containing disease progression or intolerable toxic side effects. Two dose groups were investigated: Dose group 1: B1962 35 mg/kg, intravenous infusion, Q2W, Dose group 2: B1962 45 mg/kg, intravenous infusion, Q2W.

NCT Number	NCT06838546
Lead Sponsor	Tasly Biopharmaceuticals Co., Ltd. Collaborators: Sir Run Run Shaw Hospital
Conditions	Advanced Colorectal Cancer
Enrollment	80 participants
Start Date	2025-02-24
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-01-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-20