A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gastrointestinal 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 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

16 Participants
are divided into 1 treatment group

Locations

1
Harbin Medical University Cancer Hospital HarbinHeilongjiang, China

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

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

Collaborator