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

Colorectal Cancer Clinical Trial

Official title:
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

Clinical Trial Summary

Objective: To investigate the efficacy, safety and tolerability of SI-B003 monotherapy and BL-B01D1+SI-B003 dual agents 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 mode of combination.

Clinical Trial Description

Objective: To investigate the efficacy of SI-B003 alone or BL-B01D1+SI-B003 in the treatment of patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors. To explore the safety and tolerability of SI-B003 alone and BL-B01D1+SI-B003 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 mode of combination. Secondary objective: To explore the pharmacokinetics of investigational drugs BL-B01D1 and SI-B003. To explore the immunogenicity of BL-B01D1 and SI-B003. To explore drug-drug interactions (DDI). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06008054
Study type Interventional
Source Sichuan Baili Pharmaceutical Co., Ltd.
Contact Hai Zhu, PHD
Phone +8613980051002
Email zhuhai@baili-pharm.com
Status Recruiting
Phase Phase 2
Start date November 16, 2023
Completion date December 2025
View Details
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