A Study of SI-B036 in Patients With Locally Advanced or Metastatic Head and Neck Tumors and Other Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator