Oral HRS-5041-103 for men 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
This will test an oral drug called HRS-5041-103 to see if it is safe, well tolerated, and shows activity in men with metastatic castration-resistant prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Atridia Pty Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 11 sites (Sydney, New South Wales and 10 other locations) |
| Trial ID | NCT06830850 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label trial gives single oral doses of HRS-5041-103 to men with metastatic castration-resistant prostate cancer to characterize safety, tolerability, pharmacokinetics and preliminary anti-tumor activity. Participants must have adequate bone marrow, liver and other organ function and must not receive other anti-cancer treatments close to dosing. Key exclusions include uncontrolled hypertension, recent chemotherapy/targeted therapy/immunotherapy or active gastrointestinal conditions that affect oral absorption. The trial is sponsored by Atridia Pty Ltd and is recruiting at three clinical sites in Australia.
Who should consider this trial
Good fit: Men with metastatic castration-resistant prostate cancer who have adequate organ function, can swallow oral medication, and who have not received recent anti-cancer therapies would be the ideal candidates.
Not a fit: Patients with uncontrolled hypertension, active gastrointestinal disease affecting drug absorption, recent chemotherapy or immunotherapy within four weeks, or known allergy to the drug may not be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, HRS-5041-103 could become a new oral treatment option that slows disease progression for men with metastatic castration-resistant prostate cancer.
How similar studies have performed: HRS-5041-103 appears to be an early-phase, relatively novel investigational drug with limited public clinical data, although other oral agents have shown benefit in later-phase trials for advanced prostate cancer.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sydney, New South Wales and 10 other locations
- GenesisCare North Shore (Oncology) — Sydney, New South Wales, Australia (Recruiting)
- Sydney Adventist Hospital — Sydney, New South Wales, Australia (Recruiting)
- Cancer Research SA — Adelaide, South Australia, Australia (Recruiting)
- Southern Oncology Clinical Research Unit — Adelaide, South Australia, Australia (Recruiting)
- Icon Cancer Centre South Brisbane — Brisbane, Australia (Recruiting)
- John Flynn Private Hospital — Brisbane, Australia (Recruiting)
- Eastern Health (Box Hill Hospital) — Melbourne, Australia (Recruiting)
- Linear Clinical Research Ltd — Perth, Australia (Recruiting)
- Macquarie University — Sydney, Australia (Recruiting)
- MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy — Sydney, Australia (Recruiting)
- Illawarra Shoalhaven Local Health District (Wollongong Hospital) — Wollongong, Australia (Recruiting)
Study contacts
- Study coordinator: Kathy You
- Email: kathyyou@atridia.com
- Phone: +61 02 9299 0433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.