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.
Voluntary participation in the study and provision of signed and dated informed consent;
Aged 18 to 75 years (inclusive) at the time of signing informed consent;
Patients with distant metastasis or unresectable locally advanced colorectal cancer who have disease progression or intolerable toxicities after previous standard treatment must include oxaliplatin, irinotecan and fluorouracil-based drugs in previous standard treatment regimen;
Histologically or cytopathologically confirmed adenocarcinoma of the colon or rectum, including adenocarcinoma of the appendix;
Prior therapy targeting PD- (L) 1 and VEGF/VEGFR, including concurrent use of anti-PD-1/PD-L1 monoclonal antibody in combination with drugs targeting VEGF/VEGFR, or anti-PD-1/VEGF or anti-PD-L1/VEGF bispecific antibodies or bispecific fusion proteins, or sequential use of anti-PD-1/PD-L1 monoclonal antibody and drugs targeting VEGF/VEGFR;
Received the last systemic anti-tumor treatment (biological agent therapy, etc.) within 4 weeks before the first dose, hormone anti-tumor treatment within 2 weeks before the first dose, non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, thalidomide, tumor necrosis factor, etc.) within 2 weeks before the first dose, and received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first dose;
Received systemic anti-tumor therapy in other clinical studies within 4 weeks prior to the first dose;
Radiotherapy or surgery within 4 weeks prior to the first dose and diagnostic biopsy within 7 days prior to the first dose;
Tasly Biopharmaceuticals Co., Ltd.
Lead sponsor
Sir Run Run Shaw Hospital
Collaborator