NCT06962787

A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Tyrosine Kinase Inhibitor (TKI) With or Without Pembrolizumab (BL-B01D1+TKI±Pembrolizumab) in Patients With Locally Advanced or Metastatic Renal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (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 in combination with tyrosine kinase inhibitor (TKI) with or without pembrolizumab (BL-B01D1+TKI±Pembrolizumab) in patients with locally advanced or metastatic renal cancer.

Conditions

• Renal Cancer

Interventions

Type	Name	Description
DRUG	BL-B01D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Axitinib	Oral administration, and twice daily with an interval of 12 hours.
DRUG	Lenvatinib	Oral administration, and once daily.
DRUG	Pembrolizumab	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2025-07-28
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2025-05-08
• Last updated: 2025-11-17

Locations

1 site across 1 country: China