Delving into the Latest Updates on SAK2001 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

SAK 2001, SAK-2001

Target-

Action-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Huiyu Kangcheng (Zhejiang) Pharmaceutical Technology Co., Ltd.

Active Organization

Huiyu Kangcheng (Zhejiang) Pharmaceutical Technology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价SAK2001在晚期实体瘤受试者中的安全性和耐受性，并观察该药的剂量限制性毒性（DLT），确定其在人体中的最大耐受剂量（MTD），为后续临床研究提供剂量选择依据；次要目的：评价SAK2001在晚期实体瘤受试者中的药代动力学（PK）特征；初步评价SAK2001在晚期实体瘤受试者中的抗肿瘤疗效；比较SAK2001与多西他赛注射液（泰索帝®）的PK特征、安全性和抗肿瘤疗效。

[Translation]

Primary purpose: To evaluate the safety and tolerability of SAK2001 in subjects with advanced solid tumors, observe the dose-limiting toxicity (DLT) of the drug, determine its maximum tolerated dose (MTD) in humans, and provide a basis for dose selection for subsequent clinical studies; Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of SAK2001 in subjects with advanced solid tumors; To preliminarily evaluate the anti-tumor efficacy of SAK2001 in subjects with advanced solid tumors; To compare the PK characteristics, safety and anti-tumor efficacy of SAK2001 with docetaxel injection (Taxotere®).

Start Date31 Mar 2023

Sponsor / Collaborator

Huiyu Kangcheng (Zhejiang) Pharmaceutical Technology Co., Ltd.

ChiCTR2300070027

/ Not yet recruitingPhase 1IIT

A phase I clinical study evaluating the safety, tolerability, pharmacokinetic profile, and initial antitumor efficacy of SAK2001 in subjects with advanced solid tumors

Start Date21 Mar 2023

Sponsor / Collaborator