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NCT06732531
Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to determine the safety and tolerability of intravesical BH011 in patients with high-risk non-muscle invasive bladder cancer（NMIBC） after Bacillus Calmette-Guerin（BCG） failure and to assess the preliminary efficacy.
Trial Details
NCT ID NCT06732531 Phase PHASE1 / PHASE2
Sponsor Zhuhai Beihai Biotech Co., Ltd
Status RECRUITING
Cancer Type Non-Muscle-Invasive Bladder Cancer
Interventions Locations (sample) Beijing, Beijing Municipality, China|39.9075,116.39723 Xiamen, Fujian, China|24.47979,118.08187 Changsha, Hunan, China|28.19874,112.97087 Shenyang, Liaoning, China|41.79222,123.43278 Shanghai, Shanghai Municipality, China|31.22222,121.45806
Key Eligibility Criteria
Subjects were fully informed about the study and voluntarily signed an informed consent form and were willing to complete the trial in accordance w… Male or female, ≥18 years of age at time of informed consent. First TURBT completed within 12 weeks prior to the first dose, histologically confirmed diagnosis of non-muscle invasive bladder cancer and classif… Patients who had failed intravesical administration of BCG prior to enrolment and were not candidates for or refused radical cystectomy.BCG failure… For full eligibility, visit ClinicalTrials.gov .