NCT06954077

A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open, multicenter, dose-escalation and expanded-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.

Conditions

• Gastrointestinal Tumor
• Solid Tumor

Interventions

Type	Name	Description
DRUG	BL-M09D1	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2025-05-01
• Last updated: 2025-05-31

Locations

1 site across 1 country: China