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

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HSK46575 to see how safe it is and how well it works for men with metastatic castration-resistant prostate cancer (mCRPC), which means the cancer has spread and is no longer responding to standard treatments that lower testosterone. The trial is currently looking for male participants aged 18 and older who have been diagnosed with this type of prostate cancer and have tried at least one other hormone therapy and one type of chemotherapy. To join, candidates need to be in good overall health, with a life expectancy of at least three months, and must have evidence of cancer progression despite previous treatments.

Participants in the study will take HSK46575 in pill form and will be closely monitored by healthcare professionals for any side effects and how the medication behaves in their bodies. Since this is an early-phase trial, it’s a chance for participants to access a new treatment option while contributing to important research that could help future patients. It’s important to know that not everyone will qualify for the trial, as there are specific health criteria that must be met, and participants cannot be receiving any other cancer treatments while in the study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male, aged ≥18 years;
• • 2. ECOG (Eastern Cooperative Oncology Group) 0-1, expected survival of ≥ 3 months;
• • 3. Histology or cytology confirmed adenocarcinoma of the prostate;
• • 4. Radiological evidence of metastatic bone or soft tissue lesions;
• • 5. Ongoing medical castration or previous surgical castration;
• • 6. Testosterone at castration level during screening;
• • 7. Prior to screening, subjects with evidence of disease progression while receiving ADT (androgen deprivation therapy);
• • 8. 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);
• • 9. The functional level of organs must meet the requirements.
• Exclusion Criteria:
• • 1. Subjects with known hypersensitivity to the active ingredient or excipients of HSK46575 Tablets;
• • 2. 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;
• • 3. Subjects whose toxicity from prior anticancer therapy remains \> Grade 1 before the first dose;
• • 4. 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;
• • 5. Subjects who have undergone Grade 3-4 surgery;
• • 6. Subjects who plan to receive any other antitumor therapy during the study ;
• • 7. Subjects with active metastases to central nervous system;
• • 8. Subjects with serious bone damage caused by prostate cancer bone metastasis as assessed by the investigators;
• • 9. Within 6 months before the first dose, subjects had concurrent pituitary or adrenal dysfunction;
• • 10. Subjects with uncontrolled hypertension;
• • 11. Subjects with central nervous system disorders such as epilepsy and multiple sclerosis;
• • 12. Subjects with active cardiac disease within 6 months prior to the first dose, or a history of arterial or venous thromboembolism;
• • 13. Subjects with a QTc interval prolongation to \>470 ms during the screening period calculated by the Fridericia formula；
• • 14. Subjects with a history of other malignancies;
• • 15. Subjects with a history of immunodeficiency;
• • 16. Subjects with active HBV, HCV, or syphilis infection;
• • 17. Subjects who have participated in other clinical studies within 4 weeks before the first dose;
• • 18. Other conditions.