[Translation] A Phase Ib/II clinical study evaluating the safety and efficacy of HSK46575 tablets in combination with antitumor therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).

评估HSK46575联合抗肿瘤治疗在mCRPC患者中的有效性

[Translation]

Evaluate the efficacy of HSK46575 in combination with antitumor therapy in patients with mCRPC

Start Date07 Apr 2026

Sponsor / Collaborator

Liaoning Haisco Pharmaceutical Co., Ltd.

NCT07007910

/ RecruitingPhase 1

A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of HSK46575 Tablets in Patients With Metastatic Castration-Resistant Prostate Cancer

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK（pharmacokinetics） and PD（pharmacodynamics） of HSK46575 when given orally in patients with metastatic castration-resistant prostate cancer.

Start Date18 Dec 2024

Sponsor / Collaborator

Haisco Pharmaceutical Group Co., Ltd.

CTR20263967

/ Not yet recruitingPhase 1

在健康试验参与者中评价制剂和食物对HSK46575药代动力学影响的I期临床研究

[Translation] A Phase I clinical study evaluating the effects of formulation and food on the pharmacokinetics of HSK46575 in healthy trial participants.

主要目的：评价两种HSK46575片在健康试验参与者中的药代动力学（PK）特征; 评价食物对HSK46575片药代动力学的影响。次要目的：评价两种HSK46575片在健康试验参与者中的安全性和耐受性；评价不同餐食条件下HSK46575片在健康试验参与者中的安全性和耐受性；评价食物对HSK46575片药效动力学的影响。

[Translation]

Primary Objectives: To evaluate the pharmacokinetic (PK) characteristics of two HSK46575 tablets in healthy trial participants; To evaluate the effect of food on the pharmacokinetics of HSK46575 tablets. Secondary Objectives: To evaluate the safety and tolerability of two HSK46575 tablets in healthy trial participants; To evaluate the safety and tolerability of HSK46575 tablets under different meal conditions in healthy trial participants; To evaluate the effect of food on the pharmacodynamics of HSK46575 tablets.

Start Date-

Sponsor / Collaborator

Tibet Haisco Pharmaceutical Co. Ltd.

100 Clinical Results associated with HSK46575

100 Translational Medicine associated with HSK46575

100 Patents (Medical) associated with HSK46575

100 Deals associated with HSK46575

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	China	Liaoning Haisco Pharmaceutical Co., Ltd.	07 Apr 2026
Prostatic Cancer	IND Approval	China	Tibet Haisco Pharmaceutical Co. Ltd.	04 Dec 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07007910 (ASCO2026)	Phase 1	Metastatic castration-resistant prostate cancer AR ligand-binding domain (AR-LBD) mutations	27	HSK46575 (AR-LBD mutant)	plelujvzog(bvhxxtfrdk) = most of which were Grade 1-2. The most common TRAEs were alanine aminotransferase elevation (18.5%), sinus bradycardia (11.1%), and nausea (11.1%). bbgmnyqomp (xisgoprlyw )	Positive	29 May 2026
				HSK46575 (AR-LBD mutant)

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