NCT07007910

Phase I Study of HSK46575 in Patients With Metastatic Castration-Resistant Prostate Cancer

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase. Phase Ia will contain two part: Dose Escalation Part and Extension Part. Dose Escalation Part based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK46575. The number of patients to be enrolled will be up to 10 subjects in each Extension Part cohort. Approximately 30 subjects will be enrolled in Phase Ia. Phase Ib no less than 60 subjects will be enrolled in each expansion cohort.

Conditions

• m CRPC

Interventions

Type	Name	Description
DRUG	HSK46575	co-administered with glucocorticoid and fludrocortisone, orally daily

Timeline

• Start date: 2024-12-18
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: China