Clinical trial · Interventional
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
NCT06830850CI-TRIAL-00100964recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-5041 Single dose of HRS-5041 orally administered | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- : HRS-5041 dose level 1
- description
- 240 mg BID
- interventionNames
- Drug: HRS-5041 Single dose of HRS-5041 orally administered
Primary outcomes (1)
- measure
- Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination
- timeFrame
- Screening up to study completion, an average of 1 year.
- description
- To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.
Secondary outcomes (12)
- measure
- Concentration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.