[Translation] A Phase I/II clinical study evaluating the safety, tolerability, PK/PD characteristics and preliminary efficacy of HSK39775 tablets alone in patients with advanced solid malignancies
A 部分(剂量递增)
主要目的:
评估HSK39775单药治疗在晚期实体恶性肿瘤受试者中的安全性和耐受性,确定RP2D。
次要目的:
评估HSK39775单药治疗的药代动力学(PK)特征;
评估HSK39775单药治疗的初步抗肿瘤活性 。
B部分(队列扩展)
主要目的:
依据实体瘤疗效评价标准(RECIST v1.1),评价HSK39775单药治疗时的客观缓解率(ORR)。
次要目的:
通过PFS、DoR、DCR、TTR评价HSK39775单药治疗的有效性;
进一步评价HSK39775单药治疗在晚期实体恶性肿瘤受试者中的安全性和耐受性;
进一步评价HSK39775单药治疗在晚期实体恶性肿瘤受试者中的PK特征。
[Translation] Part A (Dose Escalation)
Primary Objectives:
To evaluate the safety and tolerability of HSK39775 monotherapy in subjects with advanced solid malignancies and determine the RP2D.
Secondary Objectives:
To evaluate the pharmacokinetic (PK) characteristics of HSK39775 monotherapy;
To evaluate the preliminary anti-tumor activity of HSK39775 monotherapy.
Part B (Cohort Expansion)
Primary Objectives:
According to the Solid Tumor Efficacy Evaluation Criteria (RECIST v1.1), to evaluate the objective response rate (ORR) of HSK39775 monotherapy.
Secondary Objectives:
To evaluate the efficacy of HSK39775 monotherapy by PFS, DoR, DCR, and TTR;
To further evaluate the safety and tolerability of HSK39775 monotherapy in subjects with advanced solid malignancies;
To further evaluate the PK characteristics of HSK39775 monotherapy in subjects with advanced solid malignancies.