CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 376 target
Drug / intervention
SI-B003 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06008054
NCT06008054Phase 2RecruitingOn TrackUpdated 9mo ago
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A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

Sichuan Baili Pharmaceutical Co., Ltd.·interventional·Posted Aug 23, 2023·Updated Sep 26, 2025

In Brief

A Phase 2 clinical trial evaluating SI-B003, BL-B01D1, and 1 other intervention for Esophageal Cancer and 2 related conditions. Currently recruiting, targeting 376 participants across 1 site.

Detailed Summary

This phase II study is a clinical study to explore the efficacy and safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer, Gastric Cancer, Colorectal Cancer
CountriesChina
CollaboratorsBaili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Timeline

Phase 2Recruiting
20242025202620272028
First PostedAug 23, 2023
Enrollment StartNov 16, 2023
Primary CompletionDec 1, 2026
Study CompletionDec 1, 2027
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 2.9 years agoPrimary completion in 5 months

Interventions

SI-B003drug

Administered by intravenous infusion every 3 weeks (Q3W).

BL-B01D1drug

Administered by intravenous infusion for a cycle of 3 weeks.

PD-1 Monoclonal Antibodydrug

Administration by intravenous infusion for a cycle of 3 weeks.