Phase 2 Prostate Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For men with advanced prostate cancer (mCRPC):
- Men who have been diagnosed with a specific type of prostate cancer (adenocarcinoma) confirmed by lab testing, but not the pure small cell type.
- Men whose PSA level is at least 4 ng/mL at the screening visit and has been rising in the 6 months before screening.
- Men who have already received at least 2 previous approved treatments for their prostate cancer (beyond hormone-blocking therapy), including at least one newer anti-hormone drug (such as abiraterone, enzalutamide, apalutamide, or darolutamide) AND a specific type of radiation therapy targeting PSMA (such as 177Lu-PSMA-617).
For men and women with advanced kidney cancer (ccRCC):
- People who have been diagnosed with a specific type of kidney cancer called clear-cell renal cell carcinoma, confirmed by lab testing.
- People whose kidney cancer has spread to other parts of the body and has at least one measurable tumour spot on scans.
- People who have already received at least one approved treatment for their advanced kidney cancer, which must have included an immunotherapy drug targeting PD-1 or PD-L1, and either ipilimumab or a targeted therapy drug called a tyrosine kinase inhibitor.
Who may not be able to join:
- People who received an approved cancer treatment within 3 weeks before the first study dose, or who are still experiencing side effects from a previous treatment.
- People who received a biological cancer therapy within a certain time window before the first study dose (confirm specific timing with trial site).
- People who have previously received any therapy that targets PSMA — except for a PSMA-targeted radiation treatment (such as 177Lu-PSMA-617) in the prostate cancer group.
- People in the dose escalation phase who have had prior immunotherapy cancer treatment (other than a specific vaccine called sipuleucel-T) within a certain time before the study.
- People in the dose expansion phase (prostate cancer group only) who have had any prior immunotherapy cancer treatment.
- People who need ongoing daily use of corticosteroid medicines above a certain dose (more than 10 mg of prednisone per day or an equivalent anti-inflammatory drug) within 1 week before the first study dose.
- People who have had a significant autoimmune disease in the past 5 years that required treatment with medicines that suppress the immune system.
- People who have had brain inflammation (encephalitis), meningitis, a progressive neurological disease (except mild memory problems that do not affect daily life), or poorly controlled seizures in the year before the first study dose.
- People with an uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosed immune system deficiency.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trials Management, Regeneron Pharmaceuticals
Phone: 844-734-6643
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs); Incidence and severity of Adverse Event of Special Interests (AESIs); Incidence and severity of Serious Adverse Events (SAEs); Number of participants with Grade ≥3 laboratory abnormalities; Incidence of Dose-Limiting Toxicities (DLTs); Concentration of REGN5678 in serum over time; Concentration of REGN5678 in combination with cemiplimab in serum over time; Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR); Objective...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.