A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer

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.

Trial Details

NCT ID
NCT07407283
Phase
PHASE1 / PHASE2
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • SHR-4394
  • Rezvilutamide
  • HRS-5041 Tablets
  • Tazemetostat
Locations (sample)
  • Chengdu, Sichuan, China|30.66667,104.06667
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • 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…
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy is expected to be at least 12 weeks.
  • Must have a prostate-specific antigen (PSA) level of ≥1 ng/mL during the screening period.

For full eligibility, visit ClinicalTrials.gov.

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