NCT06008054

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To explore the efficacy, safety and tolerability 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, and to further explore the optimal dose and combination way.

Conditions

• Esophageal Cancer
• Gastric Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SI-B003	Administered by intravenous infusion every 3 weeks (Q3W).
DRUG	BL-B01D1	Administered by intravenous infusion for a cycle of 3 weeks.
DRUG	PD-1 Monoclonal Antibody	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2023-11-16
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-08-23
• Last updated: 2025-09-26

Locations

1 site across 1 country: China