[Translation] An open-label, multicenter, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of RDc001 tablets in patients with relapsed/refractory hematologic malignancies and advanced solid tumors
主要目的
1. 评价RDc001片在复发/难治血液瘤及晚期实体瘤患者中的安全性和耐受性。
2. 观察可能出现的RDc001片的剂量限制性毒性(DLT)。
3. 确定最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
次要目的 1. 评价RDc001片在复发/难治血液瘤及晚期实体瘤患者中的药代动力学特征。
2. 评价RDc001片的初步抗肿瘤疗效。
[Translation] Primary Objectives
1. Evaluate the safety and tolerability of RDc001 tablets in patients with relapsed/refractory hematologic malignancies and advanced solid tumors.
2. Observe for potential dose-limiting toxicities (DLTs) of RDc001 tablets.
3. Determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).
Secondary Objectives
1. Evaluate the pharmacokinetic profile of RDc001 tablets in patients with relapsed/refractory hematologic malignancies and advanced solid tumors.
2. Evaluate the preliminary antitumor efficacy of RDc001 tablets.