docetaxel (BH-011) / Zhuhai Beihai Biotech - LARVOL DELTA

A first-in-human trial of intravesical BH011, a novel docetaxel formulation, in patients with high risk non-muscle invasive bladder cancer (HR-NMIBC) after BCG failure: Results from a phase 1 study. (ASCO 2025) - P1/2 | "These results demonstrate the safety, tolerability and therapeutic potential of intravesical BH011 in patients with HR-NMIBC after BCG failures. The phase 2 clinical study is ongoing. Clinical trial information: NCT06732531."

Clinical • P1 data • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Renal Disease • Solid Tumor

Results of BH011 after intravesical administration in patients with CIS and/or papillary non-muscle invasive bladder cancer (NMIBC) after BCG failure: Interim results from a phase I/II clinical trial. (ASCO 2025) - P1/2 | "BH011 is a novel docetaxel formulation for intravesical administration that significantly increased the concentration of free docetaxel and bladder tissue permeability compared to TAXOTERE, which may result in a more efficient and effective tumor response. Interim results show that intravesical BH011 is well tolerated and that it has strong significant and durable clinical efficacy in patients with HR NMIBC after BCG failure, particularly in pts with CIS (CRR=100%). BH011 has the potential to have a transformative effect on the treatment landscape of NMIBC. Clinical trial information: NCT06732531."

Clinical • P1/2 data • Anemia • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Renal Disease • Solid Tumor

Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Zhuhai Beihai Biotech Co., Ltd | Active, not recruiting ➔ Recruiting | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Enrollment open • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=48 | Active, not recruiting | Sponsor: Zhuhai Beihai Biotech Co., Ltd

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor