About this trial
This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic breast cancer and other solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restriction;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Disqualifiers
Use of chemotherapy, biotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives prior to the first dose;
Receipt of immunosuppressive drug therapy within 2 weeks prior to the first dose;
History of severe cardiac or cerebrovascular disease;
Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
Trial design
Treatments tested in this trial
- SI-B036
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator