SHR3680, HS-20093, and SHR2554 combined with hormonal therapy for advanced prostate cancer

A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer

This trial will test whether adding HS-20093 or SHR2554 to a novel hormonal agent helps men with advanced prostate cancer better control their disease while continuing standard androgen-deprivation therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Nanjing, Jiangsu and 1 other locations)
• Trial ID: NCT07230106 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Men aged 18–80 with confirmed prostate adenocarcinoma, ECOG 0–1, PSA ≥1 ng/mL, on continuous androgen-deprivation therapy, able to provide tumor tissue, and with adequate organ function are the intended participants.

Not a fit: Patients with neuroendocrine or small cell histology, ECOG >1, inadequate organ function, not on continuous ADT, or unable to provide tumor tissue are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, these combinations could slow disease progression and expand treatment options for men with advanced prostate adenocarcinoma.

How similar studies have performed: Other trials of novel androgen-receptor–targeted agents combined with hormonal therapies have shown benefit, but using HS-20093 or SHR2554 in these specific combinations is relatively novel and less well studied.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu and 1 other locations

• 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

Conditions Prostate Cancer