Delving into the Latest Updates on HS-10370 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HS 10370, HS-10370, HS10370

Target

KRAS G12C

Action

inhibitors

Mechanism

KRAS G12C inhibitors(GTPase KRas G12C inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases

Active Indication

Advanced Malignant Solid NeoplasmColorectal CancerKRAS G12C mutation Solid Tumors+ [2]

Inactive Indication-

Originator Organization

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Active Organization

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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主要研究目的 1. 评价HS-10370联合治疗在KRAS G12C突变阳性的晚期NSCLC患者中的安全性和耐受性。 2. 确定HS-10370联合给药的临床试验二期推荐剂量（RP2D）剂量。次要研究目的 1. 评价HS-10370联合治疗在KRAS G12C突变阳性的晚期NSCLC患者中的有效性。 2. HS-10370原药在KRAS G12C突变阳性的晚期NSCLC患者中的药代动力学（PK）特征。

[Translation]

Main study objectives 1. To evaluate the safety and tolerability of HS-10370 combination therapy in patients with advanced NSCLC who are positive for KRAS G12C mutation. 2. To determine the recommended dose (RP2D) of the Phase II clinical trial for HS-10370 combination therapy. Secondary study objectives 1. To evaluate the efficacy of HS-10370 combination therapy in patients with advanced NSCLC who are positive for KRAS G12C mutation. 2. Pharmacokinetic (PK) characteristics of HS-10370 original drug in patients with advanced NSCLC who are positive for KRAS G12C mutation.

Start Date09 Oct 2024

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

[+1]

NCT05367778

/ RecruitingPhase 1/2

A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10370 Monotherapy in Patients with Advanced Solid Tumors

HS-10370 is an oral, highly selective, small molecular inhibitor of KRAS G12C. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10370 in Chinese advanced solid tumor patients.

Start Date03 Jun 2022

Sponsor / Collaborator

Jiangsu Hansoh Pharmaceutical Co., Ltd.

100 Clinical Results associated with HS-10370

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100 Translational Medicine associated with HS-10370

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100 Patents (Medical) associated with HS-10370

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100 Deals associated with HS-10370

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Jiangsu Hansoh Pharmaceutical Co., Ltd.	03 Jun 2022
Colorectal Cancer	Phase 1	China	Jiangsu Hansoh Pharmaceutical Co., Ltd.	30 May 2025
KRAS G12C mutation Solid Tumors	Phase 1	China	Jiangsu Hansoh Pharmaceutical Co., Ltd.	31 Oct 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 1	China	Jiangsu Hansoh Pharmaceutical Co., Ltd.	09 Oct 2024
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 1	China	Jiangsu Hansoh Pharmaceutical Co., Ltd.	27 May 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05367778 (HS-10370-101, AACR2025)	Phase 1	KRAS G12C mutation Solid Tumors KRAS G12C mutation	63	HS-10370 200 mg QD	dpvajtsdmo(xfgiysfhpg) = 28.6% tqonqlgmvy (cnzlsirygv ) View more	Positive	29 Apr 2025
NCT05367778 (HS-10370-101, AACR2025)	Phase 1	KRAS G12C mutation Solid Tumors KRAS G12C mutation	63	HS-10370 400 mg QD		Positive	29 Apr 2025
NCT05367778 (HS-10370-101, AACR2024) Manual	Phase 1	KRAS G12C mutation Solid Tumors KRAS G12C	55	HS-10370	haunztafln(gwzbvktigp) = gdkllrzjhn wvsgtewvso (rskcyuvvve ) View more	Positive	05 Apr 2024