Phase 2 Prostate Cancer Trial, Recruiting NCT05125016 Sponsor: Regeneron Pharmaceuticals Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT05125016
Recruiting Phase 2

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:

  • You have been diagnosed with prostate cancer (a specific type called adenocarcinoma) confirmed by a lab test, and you do not have a type called "pure small cell carcinoma"
  • Your prostate cancer has spread to other parts of the body, is no longer responding to hormone-lowering treatments, and your PSA level is 4 ng/mL or higher at the time of screening
  • Your cancer has gotten worse within the past 6 months, shown by a rising PSA level, new or growing tumours on scans, or 2 or more new spots appearing on a bone scan
  • You have already tried at least 2 approved treatments for advanced prostate cancer (beyond basic hormone therapy), including at least one newer hormone-blocking drug such as abiraterone, enzalutamide, apalutamide, or darolutamide, and your cancer has continued to progress or you could not tolerate those treatments

Who may not be able to join:

  • You have received certain approved biological cancer treatments within the last 3 weeks, or you are still experiencing side effects from a previous treatment
  • You have received certain biological or immune-based cancer treatments too recently before the start of this trial (confirm with trial site for exact timing)
  • You have previously received a therapy that specifically targets a protein called PSMA — though if you received a PSMA-targeting radioactive treatment (such as 177Lu-PSMA-617), you may still be eligible if at least 12 weeks have passed since your last dose
  • You currently need to take regular high-dose steroid medication (more than 10 mg of prednisone per day or a similar anti-inflammatory drug)
  • You have a significant autoimmune disease (where the immune system attacks the body) that required strong immune-suppressing treatment within the last 5 years
  • You have had brain inflammation, meningitis, an uncontrolled seizure disorder, or a significant brain or nerve condition in the past year (mild memory problems that do not affect daily life may be acceptable — confirm with trial site)
  • You have an uncontrolled HIV, Hepatitis B, or Hepatitis C infection, or a condition that weakens your immune system

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
30 November 2021
Est. completion
28 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Dose-Limiting Toxicities (DLTs); Incidence and severity of Treatment-Emergent Adverse Events (TEAEs); Incidence and severity of Serious Adverse Events (SAEs); Incidence and severity of Adverse Events of Special Interest (AESIs); REGN4336 monotherapy concentrations in serum; REGN4336 concentrations in serum in combination with REGN5678; Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov