Tests HSK46575 tablets in men with advanced prostate cancer
Tests HSK46575 tablets for safety in adults with prostate cancer that spread despite treatment.
Plain-language title generated from the registry record
Registry title: Phase I Study of HSK46575 in Patients With Metastatic Castration-Resistant Prostate Cancer
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 1
Where in China
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haisco Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07007910
- Record updated
- 6 June 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Male, aged ≥18 years; ECOG (Eastern Cooperative Oncology Group) 0-1, expected survival of ≥ 3 months; Histology or cytology confirmed adenocarcinoma of the prostate; Radiological evidence of metastatic bone or soft tissue lesions; Ongoing medical castration or previous surgical castration; Testosterone at castration level during screening; Prior to screening, subjects with evidence of disease progression while receiving ADT (androgen deprivation therapy); Had progressed on at least one novel endocrine therapy, and had progressed on at least one taxane-based chemotherapy (or those who are intolerant or refuse chemotherapy); The functional level of organs must meet the requirements.
Exclusion: Subjects who have received any antitumor therapy within 4 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; or treatment with nitrosoureas, bicalutamide, or nilutamide within 6 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; Subjects whose toxicity from prior anticancer therapy remains > Grade 1 before the first dose; Subjects who have used strong or moderate CYP3A4 inhibitors or inducers, CYP2C9 sensitive substrates, and OCT2 or MATE1 substrates within 14 days or 5 half-lives prior to the first dose of the investigational drug, whichever is longer; Subjects who have undergone Grade 3-4 surgery; Subjects who plan to receive any other antitumor therapy during the study ; Within 6 months before the first dose, subjects had concurrent pituitary or adrenal dysfunction; Subjects with active cardiac disease within 6 months prior to the first dose, or a history of arterial or venous thromboembolism; Subjects who have participated in other clinical studies within 4 weeks before the first dose; Subjects with known hypersensitivity to the active ingredient or excipients of HSK46575 Tablets; Subjects with serious bone damage caused by prostate cancer bone metastasis as assessed by the investigators; Subjects with uncontrolled hypertension; Subjects with central nervous system disorders such as epilepsy and multiple sclerosis; Subjects with a history of other malignancies; Subjects with a history of immunodeficiency; Subjects with active HBV, HCV, or syphilis infection; Other conditions; Subjects with a QTc interval prolongation to >470 ms during the screening period calculated by the Fridericia formula；; Subjects with active metastases to central nervous system.