Trials / Not Yet Recruiting
Not Yet RecruitingNCT07407283
A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer
A Multicenter, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of SHR-4394 in Combination With Anti-tumor Therapy in Participants With Prostate Cancer
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-4394 | SHR-4394. |
| DRUG | Rezvilutamide | Rezvilutamide tablets. |
| DRUG | HRS-5041 Tablets | HRS-5041 tablets. |
| DRUG | Tazemetostat | Tazemetostat tablets. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-11-01
- Completion
- 2028-04-01
- First posted
- 2026-02-12
- Last updated
- 2026-02-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07407283. Inclusion in this directory is not an endorsement.