m CRPCPhase 1NCT07007910
Phase I Study of HSK46575 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing HSK46575 in people with m CRPC, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- m CRPC
- What is being tested?
- HSK46575
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Subjects with known hypersensitivity to the active ingredient or excipients of HSK46575 Tablets;
- 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 ;
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- Subjects with active metastases to central nervous system;
- Subjects with serious bone damage caused by prostate cancer bone metastasis as assessed by the investigators;
- Within 6 months before the first dose, subjects had concurrent pituitary or adrenal dysfunction;
- Subjects with uncontrolled hypertension;
- Subjects with central nervous system disorders such as epilepsy and multiple sclerosis;
- Subjects with active cardiac disease within 6 months prior to the first dose, or a history of arterial or venous thromboembolism;
- Subjects with a QTc interval prolongation to >470 ms during the screening period calculated by the Fridericia formula；
- Subjects with a history of other malignancies;
- Subjects with a history of immunodeficiency;
- Subjects with active HBV, HCV, or syphilis infection;
- Subjects who have participated in other clinical studies within 4 weeks before the first dose;
- Other conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Ping Feng, 15388216625, 617130961@qq.com
Qiang Wei, 18980601425, wq933@hotmail.com
About this study
Official title: 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.
Read the detailed description
The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
Phase Ia will contain two part: Dose Escalation Part and Extension Part. Dose Escalation Part based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK46575. The number of patients to be enrolled will be up to 10 subjects in each Extension Part cohort. Approximately 30 subjects will be enrolled in Phase Ia.
Phase Ib no less than 60 subjects will be enrolled in each expansion cohort.
- Conditions
- m CRPC
- Being tested
- HSK46575
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK46575Drug
co-administered with glucocorticoid and fludrocortisone, orally daily
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia (Dose Escalation Part): HSK46575 | Experimental | Phase 1a (Dose Escalation Part): dose escalation of HSK46575 at various dose levels Receives: Drug: HSK46575 |
| Phase Ia (Extension Part): HSK46575 | Experimental | Phase 1a (Part B): dose extention of HSK46575 at certain dose levels Receives: Drug: HSK46575 |
| Phase Ib: HSK46575 | Experimental | Phase 1b: dose expansion for HSK46575 at dose of RP2D（Recommended Phase II Dose） Receives: Drug: HSK46575 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Highest dose level at which under 33% of patients in a cohort experience DLT（dose limiting toxicity）
Measured: Within first 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start18 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for m CRPCStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007910
- Sponsor's protocol ID
- HSK46575-101
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of HSK46575 Tablets in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07007910
- Acronym / sponsor ID
- HSK46575-101
- Conditions
- m CRPC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
Phase Ia will contain two part: Dose Escalation Part and Extension Part. Dose Escalation Part based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK46575. The number of patients to be enrolled will be up to 10 subjects in each Extension Part cohort. Approximately 30 subjects will be enrolled in Phase Ia.
Phase Ib no less than 60 subjects will be enrolled in each expansion cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia (Dose Escalation Part): HSK46575 | Experimental | Drug: HSK46575Phase 1a (Dose Escalation Part): dose escalation of HSK46575 at various dose levels |
| Phase Ia (Extension Part): HSK46575 | Experimental | Drug: HSK46575Phase 1a (Part B): dose extention of HSK46575 at certain dose levels |
| Phase Ib: HSK46575 | Experimental | Drug: HSK46575Phase 1b: dose expansion for HSK46575 at dose of RP2D（Recommended Phase II Dose） |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (18 listed)
- Subjects with known hypersensitivity to the active ingredient or excipients of HSK46575 Tablets;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK46575co-administered with glucocorticoid and fludrocortisone, orally daily | Drug | Phase Ia (Dose Escalation Part): HSK46575, Phase Ia (Extension Part): HSK46575, Phase Ib: HSK46575 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Within first 28 days of treatment
Highest dose level at which under 33% of patients in a cohort experience DLT（dose limiting toxicity）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK46575 in people with m CRPC, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunfen Li (18108214952, liyunfen@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Within first 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.