Delving into the Latest Updates on HSK42360-Na with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HSK42360-Na

Target

BRAF

Action

inhibitors

Mechanism

BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

BRAF V600 mutation-positive Neoplasms

Inactive Indication-

Originator Organization

Haisco Pharmaceutical Group Co., Ltd.

Active Organization

Haisco Pharmaceutical Group Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的： ·评价HSK42360-Na片在BRAF V600突变晚期实体瘤患者中的安全性和耐受性；确定II期临床试验推荐剂量（RP2D）。次要目的： ·评价HSK42360-Na片在BRAF V600突变晚期实体瘤患者中的药代动力学特征； ·初步评价HSK42360-Na片在BRAF V600突变晚期实体瘤患者中的疗效。探索性目的： ·评价肿瘤组织（或血液或脑脊液）样本中生物标志物特征和脑脊液中药物浓度，以及与HSK42360-Na片疗效的关系。

[Translation]

Primary Objectives: • Evaluate the safety and tolerability of HSK42360-Na tablets in patients with BRAF V600-mutant advanced solid tumors; determine the recommended dose (RP2D) for the Phase II clinical trial. Secondary Objectives: • Evaluate the pharmacokinetic characteristics of HSK42360-Na tablets in patients with BRAF V600-mutant advanced solid tumors; • Preliminary evaluation of the efficacy of HSK42360-Na tablets in patients with BRAF V600-mutant advanced solid tumors. Exploratory Objectives: • Evaluate the biomarker characteristics in tumor tissue (or blood or cerebrospinal fluid) samples and the drug concentration in cerebrospinal fluid, and their relationship with the efficacy of HSK42360-Na tablets.

Start Date04 Mar 2026

Sponsor / Collaborator

Haisco Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with HSK42360-Na

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100 Translational Medicine associated with HSK42360-Na

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100 Patents (Medical) associated with HSK42360-Na

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100 Deals associated with HSK42360-Na

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