NCT05785039

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors

Phase IIa/IIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase IIa/IIb clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors.

Detailed description

Phase IIa: To explore the safety and initial efficacy of BL-B01D1 in a variety of solid tumors such as locally advanced or metastatic urinary system tumors, and further determine RP2D. The preliminary efficacy, pharmacokinetic characteristics and immunogenicity of BL-B01D1 were evaluated. Phase IIb: To explore the efficacy of BL-B01D1 as a single agent RP2D obtained in a Phase IIa clinical study. To evaluate the safety and tolerability, pharmacokinetic characteristics and immunogenicity of BL-B01D1.

Conditions

• Urinary System Tumor
• Solid Tumor

Interventions

Type	Name	Description
DRUG	BL-B01D1	Administration by intravenous infusion

Timeline

• Start date: 2023-04-20
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-03-27
• Last updated: 2025-09-26

Locations

1 site across 1 country: China