NCT06042894

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• 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 and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	BL-B01D1	BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
DRUG	SI-B003	SI-B003 was administered by intravenous infusion on D1 in a 3-week cycle.

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-09-21
• Last updated: 2025-09-26

Locations

1 site across 1 country: China