About this trial
This study is an open-label, multicenter, non-randomized Phase I clinical study with dose-escalation and expansion cohorts, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and agree to follow the protocol requirements;
No gender restriction;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Disqualifiers
Use of chemotherapy, biotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose;
Receipt of immunosuppressive medications 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
Locations
1Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator