Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT07007910

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

Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-06-06

90

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male, aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with expected survival of at least 3 months
  • Confirmed adenocarcinoma of the prostate by histology or cytology
  • Radiological evidence of metastatic bone or soft tissue lesions
  • Undergoing medical or prior surgical castration
  • Testosterone levels at castration level during screening
  • Evidence of disease progression while receiving androgen deprivation therapy before screening
  • Progressed on at least one novel endocrine therapy and at least one taxane-based chemotherapy (or intolerant/refusing chemotherapy)
  • Adequate organ function as required by the study
Not Eligible

You will not qualify if you...

  • Known allergy to HSK46575 or its ingredients
  • Received any antitumor therapy within 4 weeks or 5 half-lives prior to first dose, or nitrosoureas, bicalutamide, or nilutamide within 6 weeks or 5 half-lives prior to first dose
  • Toxicity from prior anticancer therapy greater than Grade 1 before first dose
  • Use of strong/moderate CYP3A4 inhibitors or inducers, CYP2C9 sensitive substrates, OCT2 or MATE1 substrates within 14 days or 5 half-lives before first dose
  • Underwent Grade 3-4 surgery
  • Planning to receive other antitumor therapy during the study
  • Active metastases to the central nervous system
  • Serious bone damage from prostate cancer bone metastasis
  • Pituitary or adrenal dysfunction within 6 months before first dose
  • Uncontrolled hypertension
  • Central nervous system disorders such as epilepsy or multiple sclerosis
  • Active cardiac disease within 6 months prior to first dose or history of arterial/venous thromboembolism
  • QTc interval prolongation over 470 ms during screening
  • History of other malignancies
  • History of immunodeficiency
  • Active infection with HBV, HCV, or syphilis
  • Participation in other clinical studies within 4 weeks before first dose
  • Other unspecified conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610044

Actively Recruiting

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Research Team

Y

Yunfen Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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