NCT05942001RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Jul 2023
- Start date
- 3 Aug 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT05942001
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 100
- From 3 Aug 2023 to the primary completion date, 30 Sept 2026
- 1 site 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
- Prior treatment with an androgen receptor (AR) degrader.
- Plan to receive any other antitumor therapy during this trial.
- Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study.
Lab values
- Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
Other
- Patients with known brain metastases.
Who the study is looking for
- Able and willing to provide a written informed consent.
- Age 18-80 years old, gender unlimited.
- The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1.
- Predicted survival ≥12 weeks.
- Histological or cytological confirmed adenocarcinoma of the prostate.
- Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Jiaotong University School of Medicine, Renji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.