A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab |
| Who can participate | Inclusion Criteria: 1. Men .18 years of age. 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma. 3. mCRPC with disease progression after at least two lines of systemic therapy, including one line of second-generation anti-androgen therapy, according to one of the following criteria: 1. PSA progression as defined by a rising PSA level confirmed with an interval of \>1 week between each assessment. 2. Radiographic disease progression in soft tissue based on RECIST Version 1.1 criteria with PCWG3 modifications with or without PSA progression. 3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. NOTE: Prior approved PSMA-targeted therapies \[e. |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2025-07-09 |
| NCT ID | NCT06826768 |
| Official listing | https://clinicaltrials.gov/study/NCT06826768 |