This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with advanced colorectal cancer who have HER2 IHC3+ and have failed prior treatment with oxaliplatin, fluorouracil and irinotecan.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Participants must be ≥18 years and ≤75 years of age on the day of signing the informed consent form;
Expected survival time ≥3 months;
Patients with histologically or cytologically confirmed metastatic colorectal cancer;
Have undergone surgical treatment, radical radiotherapy, chemotherapy, immunotherapy, etc. within 4 weeks before the first dose;
Have previously received ADC drug therapy using camptothecin derivatives as toxins, or have previously received HER2-ADC drug therapy;
History of severe cardiovascular or cerebrovascular disease within half a year before screening;
Concurrent pulmonary disease resulting in severely impaired lung function;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator