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

StatusRecruiting
PhasePhase 1
Started2026-07-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 38% 16 → 10 participants
See other at-risk trials from Sichuan Baili Pharmaceutical Co., Ltd.

Amendment history

2026-09-03
Study Status, Contacts/Locations v2
Recruitment opened
Start dateestimated 2026-07→confirmed 2026-07-30
Study sitesdetails revised at 1 of 1 site
2026-07-15
Study Status, Study Design v1
Enrollment reduced: 16 → 10 participants
2026-06-25
Original filing
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.
Trial Details
NCT Number NCT07678970
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Gastrointestinal Tumor, Solid Tumor
Enrollment 10 participants
Start Date 2026-07-30
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-04