Phase II Study of BL-B01D1 Combined With Tyrosine Kinase Inhibitor With or Without Pembrolizumab for Advanced or Metastatic Kidney Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of BL-B01D1 combined with a tyrosine kinase inhibitor TKI, with or without pembrolizumab, in patients who have locally advanced or metastatic renal cancer. This Phase II clinical study aims to explore how well this combination works and monitor any side effects in this patient group. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. Participants receive BL-B01D1 through intravenous infusion in 3-week cycles, combined with either axitinib taken orally twice daily or lenvatinib taken orally once daily. Pembrolizumab may also be given by intravenous infusion every 3 weeks. Those who show clinical benefit may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons require stopping treatment. During the trial, patients will be closely monitored for tumor response, side effects, and drug levels for up to approximately 24 months. Researchers will assess outcomes such as objective response rate, progression-free survival, disease control, duration of response, and overall survival. Safety will be tracked by recording treatment-emergent adverse events. Participants will provide tumor tissue samples and undergo regular evaluations to help determine the studys results.

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