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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07778862
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Gynecological Tumors
  • Solid Tumors

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, dose-escalation and expansion, 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 gynecological tumors and other solid tumors.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
30 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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