NCT06830850 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
| NCT ID | NCT06830850 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Atridia Pty Ltd. |
| Condition | Metastatic Castration Resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-06-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2025-06-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Eligibility Criteria
IInclusion Criteria 1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. Adequate bone marrow and other vital organ functions 3. Adequate liver function tests 4. Metastatic Castration-resistant Prostate Cancer Exclusion Criteria 1. Plan to receive any other anti-tumor therapy during the study. 2. Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study. 3. Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 150 mmHg and/or diastolic blood pressure \[DBP\] \> 100 mmHg with regular anti-hypertension therapy). 4. 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. 5. Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.). 6. Active heart disease within 6 months prior to the first dosing of this study. 7. Medical history of other malignant tumor within 5 years prior to dosing. 8. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06830850 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration Resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06830850 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06830850 currently recruiting?
Yes, NCT06830850 is actively recruiting participants. Contact the research team at kathyyou@atridia.com for enrollment information.
Where is the NCT06830850 trial being conducted?
This trial is being conducted at Sydney, Australia, Sydney, Australia, Adelaide, Australia, Adelaide, Australia and 7 additional locations.
Who is sponsoring the NCT06830850 clinical trial?
NCT06830850 is sponsored by Atridia Pty Ltd.. The trial plans to enroll 25 participants.
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