[Translation] A Phase Ib/II clinical study to evaluate the safety, tolerability, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in the treatment of patients with recurrent/progressive high-grade brain glioma
Ⅰb期剂量递增主要研究目的:评价BioTTT001治疗复发/进展性高级别脑胶质瘤患者的安全性、耐受性,确定剂量限制性毒性(DLT)和最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。Ⅱ期剂量扩展主要研究目的:评价BioTTT001治疗复发/进展性高级别脑胶质瘤患者的有效性。
[Translation] The main purpose of the Phase Ib dose escalation study is to evaluate the safety and tolerability of BioTTT001 in the treatment of patients with recurrent/progressive high-grade brain glioma, and to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) and/or the Phase II recommended dose (RP2D). The main purpose of the Phase II dose expansion study is to evaluate the effectiveness of BioTTT001 in the treatment of patients with recurrent/progressive high-grade brain glioma.