Delving into the Latest Updates on HRS-8364 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

HRS-8364

Target-

Action-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Login to view timeline

主要研究目的：评价HRS-8364单药在晚期实体瘤受试者中的安全性和耐受性，以确定HRS-8364的剂量限制性毒性（DLT）、最大耐受剂量（MTD）和II期临床研究推荐剂量（RP2D）；通过客观缓解率（ORR）初步评价HRS-8364单药治疗晚期实体瘤的疗效。次要研究目的：评价单次/多次给药后HRS-8364在晚期实体瘤受试者中的药代动力学（PK）特征；初步评价食物效应对HRS-8364药代动力学的影响；初步评价HRS-8364单药在晚期实体瘤受试者中的有效性。

[Translation]

Primary study objectives: To evaluate the safety and tolerability of HRS-8364 monotherapy in patients with advanced solid tumors, to determine the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical trials (RP2D) of HRS-8364; and to preliminarily evaluate the efficacy of HRS-8364 monotherapy for advanced solid tumors through objective response rate (ORR). Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics of HRS-8364 in patients with advanced solid tumors after single/multiple doses; to preliminarily evaluate the effect of food effects on the pharmacokinetics of HRS-8364; and to preliminarily evaluate the efficacy of HRS-8364 monotherapy in patients with advanced solid tumors.

Start Date-

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with HRS-8364

Login to view more data

100 Translational Medicine associated with HRS-8364

Login to view more data

100 Patents (Medical) associated with HRS-8364

Login to view more data

100 Deals associated with HRS-8364

Login to view more data