Delving into the Latest Updates on CTS-2016 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

Mechanism

AXL modulators(AXL receptor tyrosine kinase modulators), FLT3 modulators(Tyrosine-protein kinase receptor FLT3 modulators)

Therapeutic Areas

NeoplasmsHemic and Lymphatic Diseases

Active Indication

Acute Myeloid LeukemiaHigh Risk Myelodysplastic Syndrome

Inactive Indication-

Originator Organization

Cytosinlab Pharmaceutical Technology Co., Ltd.Startup

Active Organization

Cytosinlab Pharmaceutical Technology Co., Ltd.Startup

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的评估CTS2016在复发/难治性AML或中高危MDS受试者中的安全性和耐受性。确定CTS2016的剂量限制性毒性（DLT）。确定最大耐受剂量（MTD）和/或II期研究中的推荐剂量（RP2D）。次要目的评估CTS2016在复发/难治性AML或中高危MDS受试者中的药代动力学特征，获取初步药代动力学参数；评估CTS2016 在复发/难治性AML或中高危MDS受试者中的初步疗效，为后续临床试验推荐剂量提供依据。探索性目的评估CTS2016在复发/难治性AML或中高危MDS受试者中的药效动力学特征。

[Translation]

Primary Objectives Evaluate the safety and tolerability of CTS2016 in subjects with relapsed/refractory AML or intermediate- and high-risk MDS. Determine the dose-limiting toxicity (DLT) of CTS2016. Determine the maximum tolerated dose (MTD) and/or the recommended dose (RP2D) in Phase II studies. Secondary Objectives Evaluate the pharmacokinetic characteristics of CTS2016 in subjects with relapsed/refractory AML or intermediate- and high-risk MDS and obtain preliminary pharmacokinetic parameters; Evaluate the preliminary efficacy of CTS2016 in subjects with relapsed/refractory AML or intermediate- and high-risk MDS to provide a basis for the recommended dose in subsequent clinical trials. Exploratory Objectives Evaluate the pharmacodynamic characteristics of CTS2016 in subjects with relapsed/refractory AML or intermediate- and high-risk MDS.

Start Date27 Feb 2023

Sponsor / Collaborator

Cytosinlab Pharmaceutical Technology Co., Ltd.Startup

100 Clinical Results associated with CTS-2016

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100 Translational Medicine associated with CTS-2016

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100 Patents (Medical) associated with CTS-2016

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100 Deals associated with CTS-2016

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 1	CN	Cytosinlab Pharmaceutical Technology Co., Ltd.Startup	27 Feb 2023
High Risk Myelodysplastic Syndrome	Phase 1	CN	Cytosinlab Pharmaceutical Technology Co., Ltd.Startup	27 Feb 2023