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.
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.
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.
Planning to receive any other anti-tumor therapy during the course of this study.
Have received any other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first dose in this study.
Have undergone surgery requiring endotracheal intubation and general anesthesia within 28 days prior to the first dose, minor diagnostic or superficial surgery within 7 days prior to the first dose, or are scheduled to undergo elective surgery during the trial period.
Have not recovered from adverse events due to prior anti-tumor therapy to ≤ Grade 1 according to NCI-CTCAE v6.0 (with the exception of Grade 2 peripheral neuropathy, alopecia, hypothyroidism controlled with hormone replacement therapy, and well-controlled type 1 diabetes managed with insulin).
Single group
SHR-4394
DrugSHR-4394.
Rezvilutamide
DrugRezvilutamide tablets.
HRS-5041 Tablets
DrugHRS-5041 tablets.
Tazemetostat
DrugTazemetostat tablets.
Recommended Phase 2 Dose (RP2D) of SHR-4394 combined with anti-tumor therapy in prostate cancer participants
Phase I.
The incidence and severity of adverse events (AEs)
Phase I.
Prostate-Specific Antigen response rate (PSA50)
Phase II.
Objective Response Rate (ORR)
Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.
Disease Control Rate (DCR)
Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.
Duration of Response (DoR)
Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.
Prostate-Specific Antigen (PSA) Response Rate
Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.
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