HSK46575 for 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

This trial will test an oral drug called HSK46575 for safety, tolerability, and how it behaves in men with metastatic castration‑resistant prostate cancer who have progressed on hormonal therapy and typically chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07007910 on ClinicalTrials.gov

What this trial studies

This is an open‑label Phase I study with a dose‑escalation (Phase Ia) using a 3+3 design and a dose‑expansion phase (Phase Ib) to characterize safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally given HSK46575. Phase Ia includes escalation and extension cohorts with about 30 subjects planned, and Phase Ib plans expansion cohorts with no fewer than 60 subjects per cohort. The trial enrolls men with histologically confirmed metastatic castration‑resistant prostate cancer who have castrate testosterone levels and prior progression on novel endocrine therapy and usually taxane chemotherapy. Key outcomes are dose‑limiting toxicities, recommended phase II dose, PK/PD profiles, and preliminary signals of clinical activity.

Who should consider this trial

Good fit: Men aged 18 or older with confirmed metastatic castration‑resistant prostate cancer, castrate testosterone levels, ECOG 0–1, and prior progression on at least one novel endocrine therapy and typically a taxane chemotherapy are the intended participants.

Not a fit: Patients with recent antitumor therapy within four weeks, known hypersensitivity to HSK46575, poor organ function, or ECOG performance status above 1 may not be eligible and are less likely to benefit from this early‑phase treatment.

Why it matters

Potential benefit: If successful, HSK46575 could provide a new oral treatment option that controls disease or is better tolerated for men with advanced, treatment‑resistant prostate cancer.

How similar studies have performed: Other oral hormonal and targeted agents have produced meaningful disease control in some men with mCRPC, but HSK46575 is a novel compound and its clinical benefits in patients remain unproven.

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yunfen Li

Conditions m CRPC