NCT07407283 A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer
| NCT ID | NCT07407283 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2027-11 |
Trial Parameters
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Brief Summary
The study aims to assess the safety and tolerability of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer, and determine the recommended Phase II dose (RP2D); To evaluate of the efficacy of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer based on Prostate-Specific Antigen (PSA) response rate.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 to 85 years (inclusive) at the time of signing the informed consent form (with an upper age limit of 80 years for the dose escalation phase), and male. 2. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Life expectancy is expected to be at least 12 weeks. 4. Must have a prostate-specific antigen (PSA) level of ≥1 ng/mL during the screening period. 5. Ongoing therapy with a luteinizing hormone-releasing hormone analog (LHRHa) for medical castration or prior bilateral orchiectomy for surgical castration; participants who have not undergone bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the study period. 6. Must have histologically or cytologically confirmed prostate adenocarcinoma, without a diagnosis of neuroendocrine carcinoma or small cell carcinoma. 7. Must have radiographically confirmed metastatic disease by CT/MRI or radionuclide bone scan (⁹⁹ᵐTc). 8. Male participants with femal
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