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

Phase I Study of HSK46575 in Patients With Metastatic Castration-Resistant Prostate Cancer (NCT07007910) is a Phase 1 interventional studying m CRPC, sponsored by Haisco Pharmaceutical Group Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For m CRPC, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused m CRPC subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

HSK46575

co-administered with glucocorticoid and fludrocortisone, orally daily

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

West China Hospital of Sichuan University

Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07007910), the sponsor (Haisco Pharmaceutical Group Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07007910 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07007910?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07007910?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07007910. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07007910. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.