RecruitingPhase 1NCT07007910

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


Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

90 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I study testing a new drug called HSK46575 in men with metastatic castration-resistant prostate cancer (mCRPC) — prostate cancer that has spread and is no longer responding to standard hormone therapy. **You may be eligible if...** - You are a man aged 18 or older - You have confirmed prostate adenocarcinoma that has spread (metastatic disease on imaging) - Your testosterone is at castration levels (from medical or surgical treatment) - Your cancer has progressed despite hormone therapy and after at least one newer hormone drug and one taxane-based chemotherapy - Your overall health is good (ECOG 0–1) and expected survival is at least 3 months **You may NOT be eligible if...** - You have received certain cancer therapies within the past 4–6 weeks - You still have significant side effects from prior treatments - You have taken certain medications that interact with HSK46575 within the past 14 days - You have unresolved serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHSK46575

co-administered with glucocorticoid and fludrocortisone, orally daily


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT07007910