[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HS248 in patients with advanced solid tumors

主要目的：评估HS248在晚期实体瘤患者中的安全性和耐受性，并确定HS248的最大耐受剂量（MTD）和/或推荐II期剂量（RP2D）。次要目的：评估HS248在晚期实体瘤患者中的药代动力学（PK）特征；评估HS248在晚期实体瘤患者中的初步抗肿瘤活性。其他目的：如数据允许，基于群体PK（PopPK）分析方法，探索性描述HS248在晚期实体瘤患者中的PK特征；如数据允许，评估HS248在晚期实体瘤患者中的暴露与疗效和不良事件（AE）之间的关系；探索HS248在晚期实体瘤患者中的骨髓来源的抑制性细胞（MDSC）和CD8+T细胞的变化。

[Translation]

Primary objective: To evaluate the safety and tolerability of HS248 in patients with advanced solid tumors and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of HS248. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of HS248 in patients with advanced solid tumors; To evaluate the preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. Other objectives: If data permit, based on the population PK (PopPK) analysis method, to explore the PK characteristics of HS248 in patients with advanced solid tumors; If data permit, to evaluate the relationship between exposure and efficacy and adverse events (AEs) of HS248 in patients with advanced solid tumors; To explore the changes of myeloid-derived suppressor cells (MDSC) and CD8+T cells in patients with advanced solid tumors treated with HS248.

Start Date19 Dec 2022

Sponsor / Collaborator

Hanhui Pharmaceutical Co. Ltd. (China)

NCT05759234 / RecruitingPhase 1

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HS248 in the Treatment of Patients With Advanced Solid Tumors

This study is a non-random, open multi-center study This study is a non-random, open multi-center phase I study, aimed at evaluation period research, aimed at In the evaluation phase study, it aims to evaluate the safety, tolerance PK characteristics and preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. The study was divided into 2 phases, including dose escalation and dose expansion。

Start Date15 Nov 2022

Sponsor / Collaborator

Hanhui Pharmaceutical Co. Ltd. (China)

100 Clinical Results associated with HS248

100 Translational Medicine associated with HS248

100 Patents (Medical) associated with HS248

100 Deals associated with HS248

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Hanhui Pharmaceutical Co. Ltd. (China)	15 Nov 2022

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