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New treatment option for m CRPC
Official title Phase I Study of HSK46575 in Patients With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07007910
What this study is testing
What is HSK46575?
HSK46575 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for m crpc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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;
You likely can't join if
- people with known hypersensitivity to the active ingredient or excipients of HSK46575 Tablets;
- people who have received any antitumor therapy within 4 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; or treatment with...
- people whose toxicity from prior anticancer therapy remains \> Grade 1 before the first dose;
- people who have used strong or moderate CYP3A4 inhibitors or inducers, CYP2C9 sensitive substrates, and OCT2 or MATE1 substrates within 14 days or 5...
- people who have undergone Grade 3-4 surgery;
- people who plan to receive any other antitumor therapy during the study ;
See the full eligibility criteria
- 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, people 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.
- people with known hypersensitivity to the active ingredient or excipients of HSK46575 Tablets;
- people 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...
- people whose toxicity from prior anticancer therapy remains \> Grade 1 before the first dose;
- people 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...
- people who have undergone Grade 3-4 surgery;
- people who plan to receive any other antitumor therapy during the study ;
- people with active metastases to central nervous system;
- people with serious bone damage caused by prostate cancer bone metastasis as assessed by the investigators;
- Within 6 months before the first dose, people had concurrent pituitary or adrenal dysfunction;
- people with uncontrolled hypertension;
- people with central nervous system disorders such as epilepsy and multiple sclerosis;
- people with active cardiac disease within 6 months prior to the first dose, or a history of arterial or venous thromboembolism;
- people with a QTc interval prolongation to \>470 ms during the screening period calculated by the Fridericia formula；
- people with a history of other malignancies;
- people with a history of immunodeficiency;
- people with active HBV, HCV, or syphilis infection;
- people who have participated in other clinical studies within 4 weeks before the first dose;
- Other conditions.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.