Delving into the Latest Updates on HS-10352 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HS 10352, HS10352

Target

PI3Kα

Mechanism

PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Locally advanced breast cancerMetastatic breast cancerHormone receptor positive HER2 negative breast cancer+ [4]

Inactive Indication-

Originator Organization

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Active Organization

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Henan Cancer Hospital

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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主要研究目的和研究内容如下： 1) 定量分析受试者口服[14C]HS-10352后排泄物中的总放射性，获得人体放射性排泄率数据和主要排泄途径。 2) 获得受试者口服[14C]HS-10352后人血浆、尿液和粪便的放射性代谢物谱，鉴定主要代谢产物，确定代谢途径及消除途径。 3) 定量分析受试者单次口服[14C]HS-10352后全血和血浆中的总放射性，获得血浆总放射性的药代动力学参数，并考察全血和血浆中总放射性的分配情况。次要研究目的和研究内容如下： 1) 采用已验证的LC-MS/MS方法定量分析血浆中HS-10352和代谢产物（如适用）的浓度，获得血浆中HS-10352和代谢产物（如适用）的药代动力学参数。 2) 观察[14C]HS-10352单次给药后受试者的安全性。

[Translation]

The main research objectives and contents are as follows: 1) Quantitatively analyze the total radioactivity in the excreta of subjects after oral administration of [14C]HS-10352, and obtain the data on human radioactive excretion rate and main excretion pathways. 2) Obtain the radioactive metabolite spectrum of human plasma, urine and feces after oral administration of [14C]HS-10352, identify the main metabolites, determine the metabolic pathways and elimination pathways. 3) Quantitatively analyze the total radioactivity in whole blood and plasma of subjects after a single oral administration of [14C]HS-10352, obtain the pharmacokinetic parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma. The secondary research objectives and contents are as follows: 1) Quantitatively analyze the concentration of HS-10352 and metabolites (if applicable) in plasma using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of HS-10352 and metabolites (if applicable) in plasma. 2) Observe the safety of subjects after a single dose of [14C]HS-10352.

Start Date27 Jun 2023

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

[+1]

CTR20231700

/ CompletedPhase 1

利福平胶囊对HS-10352片的药代动力学影响研究

[Translation] Study on the effect of rifampicin capsule on the pharmacokinetics of HS-10352 tablets

主要研究目的：评价利福平胶囊对HS-10352片药代动力学的影响。次要研究目的：评价健康受试者口服HS-10352片和利福平胶囊后的安全性。

[Translation]

Primary study objective: To evaluate the effect of rifampicin capsules on the pharmacokinetics of HS-10352 tablets. Secondary study objective: To evaluate the safety of HS-10352 tablets and rifampicin capsules after oral administration in healthy subjects.

Start Date26 Jun 2023

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

[+1]

100 Clinical Results associated with HS-10352

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100 Translational Medicine associated with HS-10352

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100 Patents (Medical) associated with HS-10352

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1

Literatures (Medical) associated with HS-10352

01 Dec 2023·Cancer medicine

HS‐10352 in hormone receptor‐positive, HER2‐negative advanced breast cancer: A phase 1 dose‐escalation trial

Article

Author: Wang, Ying ; Ouyang, Quchang ; Li, Chuan ; Zhang, Jian ; Hu, Xichun ; Wei, Hongying ; Wu, Qiong ; Qian, Xiaoling

Abstract:

Background:

Approximately 40% of patients with hormone receptor (HR)‐positive and human epidermal growth factor receptor 2 (HER2)‐negative advanced breast cancer (ABC) exhibit PIK3CA mutations.

Aims:

This study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of HS‐10352, a selective PI3Kα inhibitor, in this patient population.

Materials and Methods:

Conducted as a phase 1 dose‐escalation trial, HS‐10352 was administered orally once‐daily (QD) at dose levels of 2, 4, 6, and 8 mg. The primary endpoints were dose‐limiting toxicity (DLT) and the maximum tolerated dose (MTD). This study is registered at ClinicalTrials.gov (NCT04631835).

Results:

Between August 2020 and March 2022, a total of 18 female patients were enrolled. DLT, manifested as hyperglycemia, occurred in two patients in the 8 mg QD group, establishing an MTD of 6 mg QD. The most common treatment‐related adverse events were hyperglycemia (88.9%) and weight loss (61.3%). In the 6 mg QD group, four patients (66.7%) had a partial response (PR), and one (16.7%) had stable disease (SD). Among the four patients with PIK3CA mutated tumors in this dosage group, three (75.0%) had PR and one (25.0%) had SD. The median progression‐free survival was not reached (95% confidence interval, 11.1‐NA).

Discussion and Conclusion:

HS‐10352 at 6 mg QD was well‐tolerated in patients with HR‐positive, HER2‐negative ABC, and showed preliminary antitumor activity in patients with PIK3CA mutated tumors. These findings support the further clinical development of HS‐10352.

100 Deals associated with HS-10352

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally advanced breast cancer	Phase 2	-	Henan Cancer Hospital	01 Mar 2025
Metastatic breast cancer	Phase 2	-	Henan Cancer Hospital	01 Mar 2025
Hormone receptor positive HER2 negative breast cancer	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	12 Jan 2022
Human epidermal growth factor 2 negative carcinoma of breast	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	12 Jan 2022
Advanced breast cancer	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	28 Aug 2020
HER2-negative breast cancer	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	28 Aug 2020
Hormone Receptor Positive Breast Adenocarcinoma	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	28 Aug 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04631835 (AACR2022) Manual	Phase 1	Advanced breast cancer	18	HS-10352	aswdywxcip(yskjzdqgmp) = apmznandrs aipsjdteng (oryqetoxhv ) View more	Positive	15 Jun 2022
				HS-10352 (pts with PIK3CA mutation)	ngsrtoarha(ycnvregniy) = qtsxqiarmm nmztywslne (iktcwmiefw ) View more