Testing HRS-5041 for advanced prostate cancer
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
This study is testing a new drug called HRS-5041 to see if it is safe and effective for men with advanced prostate cancer who haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05942001 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and preliminary efficacy of HRS-5041 in men with metastatic castration-resistant prostate cancer (mCRPC). It aims to identify the maximum tolerated dose and dose-limiting toxicity of HRS-5041, which will inform future phase II studies. Participants will receive HRS-5041 and be monitored for their response and any adverse effects. The study is designed for men who have progressed after taxane chemotherapy and at least one hormonal therapy.
Who should consider this trial
Good fit: Ideal candidates are men aged 18-80 with confirmed metastatic castration-resistant prostate cancer who have previously undergone taxane chemotherapy and hormonal therapy.
Not a fit: Patients with prior treatment using an androgen receptor degrader or those with brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment choices.
How similar studies have performed: While this approach is novel, similar studies targeting advanced prostate cancer have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Suyu Fan
- Email: suyu.fan@hengrui.com
- Phone: +0518-81220121
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.