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Tests treatment safety and results for Metastatic Castration Resistant Prostate Cancer
Official title A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06830850
What this study is testing
What is HRS-5041 Single dose of HRS-5041 orally administered?
HRS-5041 Single dose of HRS-5041 orally administered is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic castration resistant prostate cancer.
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
- To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects 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
- I1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- Metastatic Castration-resistant Prostate Cancer
You likely can't join if
- Plan to receive any other anti-tumor therapy during the study.
- Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first...
- Uncontrolled hypertension (systolic blood pressure [SBP] \> 150 mmHg and/or diastolic blood pressure [DBP] \> 100 mmHg with regular anti-hypertension...
- Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active...
- Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
- Active heart disease within 6 months prior to the first dosing of this study.
See the full eligibility criteria
- I1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- Metastatic Castration-resistant Prostate Cancer
- Plan to receive any other anti-tumor therapy during the study.
- Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
- Uncontrolled hypertension (systolic blood pressure [SBP] \> 150 mmHg and/or diastolic blood pressure [DBP] \> 100 mmHg with regular anti-hypertension therapy).
- Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption...
- Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
- Active heart disease within 6 months prior to the first dosing of this study.
- Medical history of other malignant tumor within 5 years prior to dosing.
- Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Adelaide, South Australia, Australia
- Brisbane, Australia
- Melbourne, Australia
- Perth, Australia
- Sydney, Australia
- Wollongong, Australia
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 Sydney, New South Wales, Australia; Adelaide, South Australia, Australia; Brisbane, Australia; Melbourne, Australia; Perth, Australia; Sydney, Australia and 1 more location(s). 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.