Clinical trial · Interventional
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
NCT05942001CI-TRIAL-00124807recruitingPhase 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)
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.
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 |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate tablets | Drug | Abiraterone | ALIAS |
| Docetaxel injection | Drug | Docetaxel | ALIAS |
| Enzalutamide Soft Capsules | Drug | — | UNRESOLVED |
| HRS-5041 | Drug | — | UNRESOLVED |
| Prednisone Acetate Tablets | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- HRS-5041
- interventionNames
- Drug: HRS-5041
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel Injection + Prednisone Acetate Tablets group
- interventionNames
- Drug: Docetaxel injection
- Drug: Prednisone Acetate Tablets
- type
- ACTIVE_COMPARATOR
- label
- Abiraterone Acetate Tablets + Prednisone Acetate Tablets group
- interventionNames
- Drug: Abiraterone acetate tablets
- Drug: Prednisone Acetate Tablets
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. Age 18-80 years old, gender unlimited. 3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1. 4. Predicted survival ≥12 weeks. 5. Histological or cytological confirmed adenocarcinoma of the prostate. 6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy. Exclusion Criteria: 1. Prior treatment with an androgen receptor (AR) degrader. 2. Plan to receive any other antitumor therapy during this trial. 3. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study. 4. Patients with known brain metastases. 5. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
References
Publications (0)
Data not yet available
No reference posted for this study.