NCT06471205

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (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 BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	BL-B01D1	Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.
DRUG	PD-1 Monoclonal Antibody	Administration by intravenous infusion for a cycle of 3 weeks (Q3W).

Timeline

• Start date: 2024-08-02
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-06-24
• Last updated: 2025-05-07

Locations

1 site across 1 country: China