[Translation] A phase IIa study evaluating the safety, tolerability, pharmacokinetic characteristics, dose escalation, and expansion of QHRD110 in combination with temozolomide in recurrent or progressive high-grade gliomas.
主要目的:
评估QHRD110联合替莫唑胺在复发或进展的高级别脑胶质瘤中的安全性和耐受性。
次要目的:
评估QHRD110联合替莫唑胺治疗在复发或进展的高级别脑胶质瘤患者中的最大耐受剂量(MTD)或最佳生物效应剂量(OBD)和RP2D;
测定QHRD110联合替莫唑胺在复发或进展高级别脑胶质瘤患者中药代动力学特性(PK);
测定QHRD110联合替莫唑胺在复发或进展高级别脑胶质瘤患者中单药治疗的初步疗效。
探索性目的:
评估QHRD110联合替莫唑胺在复发或进展的高级别脑胶质瘤患者脑脊液中的药物浓度;
评估QHRD110联合替莫唑胺在复发或进展的高级别脑胶质瘤患者中的药效学(PD)
[Translation] Primary Objective: To evaluate the safety and tolerability of QHRD110 in combination with temozolomide in patients with recurrent or progressive high-grade gliomas.
Secondary Objectives: To evaluate the maximum tolerated dose (MTD) or best biological effect dose (OBD) and RP2D of QHRD110 in combination with temozolomide in patients with recurrent or progressive high-grade gliomas; to determine the pharmacokinetic characteristics (PK) of QHRD110 in combination with temozolomide in patients with recurrent or progressive high-grade gliomas; to determine the preliminary efficacy of QHRD110 in combination with temozolomide as monotherapy in patients with recurrent or progressive high-grade gliomas.
Exploratory Objectives: To evaluate the drug concentrations of QHRD110 in combination with temozolomide in the cerebrospinal fluid of patients with recurrent or progressive high-grade gliomas; to evaluate the pharmacodynamics (PD) of QHRD110 in combination with temozolomide in patients with recurrent or progressive high-grade gliomas.