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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07678970
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Tumor
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SI-B036 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.

Study Details

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.

Key Dates

First listed
Jul 1, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SI-B036
    Participants receive SI-B036 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Phase Ia: Dose limiting toxicity (DLT) [ Time Frame: Up to 21 days after the first dose ]

Central Contacts

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