[Translation] Phase I/II clinical trial of safety, tolerability, pharmacokinetics and preliminary efficacy of BH011 injection in the treatment of high-risk non-muscle-invasive bladder cancer patients with BCG failure
主要目的:Ⅰ期剂量探索研究:评估BH011注射液膀胱灌注治疗BCG治疗失败的高危NMIBC受试者的安全性和耐受性,确定最大耐受剂量(MTD)或Ⅱ期临床试验推荐剂量(RP2D)。Ⅱ期剂量扩展研究;评估BH011注射液膀胱灌注治疗BCG治疗失败的高危NMIBC受试者的有效性。
[Translation] Main purpose: Phase I dose-finding study: to evaluate the safety and tolerability of BH011 injection in the treatment of high-risk NMIBC subjects who failed BCG therapy, and to determine the maximum tolerated dose (MTD) or the recommended dose for phase II clinical trials (RP2D ). Phase II dose-expansion study; evaluating the efficacy of intravesical infusion of BH011 injection in the treatment of high-risk NMIBC subjects who failed BCG therapy.