[Translation] A multicenter, non-randomized, non-controlled, open-label phase I/II study to observe the safety and preliminary efficacy of catumaxomab in patients with non-muscle invasive bladder cancer who have failed or are intolerant to BCG therapy
主要目的:
观察评估卡妥索单抗膀胱灌注治疗BCG 治疗失败或不耐受的非肌层
浸润性膀胱癌的安全性和初步疗效。
次要目的:
评估卡妥索单抗膀胱灌注的药代/药效动力学特征。
[Translation] Primary objective:
To observe and evaluate the safety and preliminary efficacy of intravesical instillation of catumaxomab in the treatment of non-muscle-invasive bladder cancer that has failed or is intolerant to BCG treatment.
Secondary objective:
To evaluate the pharmacokinetic/pharmacodynamic characteristics of intravesical instillation of catumaxomab.