Delving into the Latest Updates on SYH-2043 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

+ [1]

Target

CDK2 x CDK4 x CDK6

Mechanism

CDK2 inhibitors(Cyclin-dependent kinase 2 inhibitors), CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Breast CancerAdvanced cancerMetastatic breast cancer+ [1]

Inactive Indication-

Originator Organization

CSPC Ouyi Pharmaceutical Co., Ltd.

Active Organization

Conjupro Biotherapeutics, Inc.

CSPC Pharmaceutical Group Ltd.

CSPC Ouyi Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价SYH2043片单药及联合给药治疗晚期恶性肿瘤患者的安全性和耐受性。确定SYH2043片单药及联合给药的最大耐受剂量（MTD）、II期研究推荐剂量（RP2D）。次要目的：评价SYH2043片单药及联合给药的药代动力学（PK）特征和药效动力学（PD）特征。评价SYH2043片单药及联合给药的初步抗肿瘤活性。

[Translation]

Primary objective: To evaluate the safety and tolerability of SYH2043 tablets alone and in combination for the treatment of patients with advanced malignant tumors. To determine the maximum tolerated dose (MTD) and recommended dose (RP2D) for phase II study of SYH2043 tablets alone and in combination. Secondary objective: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of SYH2043 tablets alone and in combination. To evaluate the preliminary antitumor activity of SYH2043 tablets alone and in combination.

Start Date23 Mar 2023

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

NCT05728541

/ Not yet recruitingPhase 1

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYH2043 in Patients With Advanced Malignant Tumors

The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SYH2043 in patients with advanced malignant tumors.

Start Date01 Mar 2023

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

100 Clinical Results associated with SYH-2043

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100 Translational Medicine associated with SYH-2043

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100 Patents (Medical) associated with SYH-2043

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100 Deals associated with SYH-2043

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 1	CN	CSPC Pharmaceutical Group Ltd.	14 Jun 2023
Advanced cancer	Phase 1	CN	CSPC Ouyi Pharmaceutical Co., Ltd.	23 Mar 2023
Metastatic breast cancer	Phase 1	CN	Conjupro Biotherapeutics, Inc.	-
Advanced breast cancer	IND Approval	CN	CSPC Ouyi Pharmaceutical Co., Ltd.	10 Apr 2024