NCT06830850Active, not recruitingPhase 1
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
A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 12 Feb 2025
- Start date
- 15 Jun 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Atridia Pty Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT06830850
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 25
- From 15 Jun 2025 to the primary completion date, 30 Dec 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Active heart disease within 6 months prior to the first dosing of this study.
Other illness
- 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, distribution, metabolism, or elimination of IP.
- Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
- 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.
Criteria the registry did not label
- IInclusion Criteria
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southern Oncology Clinical Research Unit Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Cancer Research SA Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| ICON Cancer Centre South Brisbane Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| John Flynn Private Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Eastern Health - Box Hill Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Linear Clinical Research, LTD Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| GenesisCare North Shore (Oncology) Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Sydney Adventist Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Macquarie University Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Illawarra Shoalhaven Local Health District (Wollongong Hospital) Coordinator of this site? Confirm its status | Wollongong | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.