Testing HRS-5041 for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DEC003M in Advanced Prostate Cancer

  This early-phase study tests DEC003M in adults with metastatic castration-resistant prostate cancer to see if it can be safely given and whether it shows signs of activity.

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• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

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• GDC-1261 in advanced or metastatic prostate cancer

  This study tests GDC-1261 to see if it is safe and how it behaves in people with advanced or metastatic prostate cancer who have progressed on prior therapy.

  Recruiting at 6 sites Phase 1/2 Genentech, Inc. · Scottsdale, Arizona and 5 other locations · NCT07567846

• QLC5508 and QLH12016 with other anti-tumor therapies in advanced prostate cancer

  This study tests QLC5508 and QLH12016, alone or with standard anti-tumor medicines, in men with advanced prostate cancer to see if they are safe and may help control the disease.

  Recruiting Phase 1/2 Qilu Pharmaceutical Co., Ltd. · Tianjin, Tianjin Municipality · NCT07198633

• HS-20093 plus HRS-5041 for advanced prostate cancer

  This phase Ib trial will test whether combining HS-20093, a B7-H3–targeted antibody-drug conjugate, with HRS-5041, an androgen receptor–targeting PROTAC, is safe and tolerable in men with metastatic castration-resistant prostate cancer who have progressed on prior hormonal therapy.

  Recruiting Phase 1 Hansoh BioMedical R&D Company · Shanghai · NCT07115446

• Mini-tumors to guide treatment for aggressive prostate cancer

  We will grow tiny, patient-derived mini-tumors in the lab to test which treatments work best for men with aggressive or metastatic prostate cancer.

  Recruiting Maastricht Radiation Oncology · Heerlen, Limburg and 2 other locations · NCT07004582

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.