About this trial
This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 Bispecific Antibody Injection in patients with locally advanced or metastatic head and neck tumors and other solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
No gender restriction;
Age: ≥18 years and ≤75 years;
Life expectancy ≥3 months;
Disqualifiers
Received chemotherapy, biotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;
Received 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
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator