SHR3680, HS-20093, and SHR2554 combined with hormonal therapy 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 Phase II, multicenter study enrolls men with histologically confirmed prostate adenocarcinoma into two treatment cohorts to receive either HS-20093 or SHR2554 in combination with a novel hormonal agent alongside ongoing androgen-deprivation therapy. Participants must have ECOG performance status 0–1, PSA ≥1 ng/mL, adequate organ function, and provide tumor tissue for retrospective genetic testing. Safety, tolerability, and signals of anti-tumor activity will be monitored during treatment at participating centers. The trial is conducted at hospitals in Nanjing and Tianjin, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent.
2. Aged 18 to 80 years (inclusive), male.
3. ECOG performance status of 0 or 1.
4. Expected survival time ≥12 weeks.
5. Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma.
6. Able to provide sufficient tumor tissue samples for retrospective genetic testing.
7. Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration).
8. PSA level ≥1 ng/ml at screening.
9. Adequate organ function levels at baseline assessment.
10. Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.

Exclusion Criteria:

1. Known hypersensitivity or intolerance to the investigational drug(s) or their excipients.
2. Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0.
3. Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment.
4. Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment.
5. Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment.
6. Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months.
7. Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease.
8. Poorly controlled tumor-related pain.
9. Dysphagia or other conditions significantly affecting drug absorption.
10. Known central nervous system metastases or primary brain tumors.
11. Significant pericardial, pleural, or peritoneal effusion requiring intervention.
12. Severe cardiovascular or cerebrovascular diseases.
13. Moderate to severe pulmonary disease significantly affecting respiratory function.
14. Poorly controlled diabetes.
15. Serious active infections within 14 days prior to enrollment.
16. Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases.
17. History of other malignancies within 5 years prior to enrollment.
18. Any other condition deemed by the investigator to potentially affect the study.

Where it's running

• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Wenliang Wang
• Email: wenliang.wang@hengrui.com
• Phone: +86-0518-82342973

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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.