Phase 1 Prostate Cancer Trial, Recruiting NCT07543055 Sponsor: Regeneron Pharmaceuticals Condition: Prostate Cancer
Back to Prostate Cancer

Phase 1 Prostate Cancer Trial, Recruiting

NCT07543055
Recruiting Phase 1

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:

  • People who have been diagnosed with a specific type of prostate cancer (adenocarcinoma) confirmed by a tissue or cell sample, where the cancer is no longer responding to hormone treatment — but not a pure small cell type.
  • People whose prostate cancer has spread to other parts of the body, is no longer responding to hormone therapy (castration-resistant), has a PSA blood test result of 4 ng/mL or higher at the screening visit, and has shown signs of getting worse within the 6 months before screening.
  • People who have already received at least 2 rounds of approved systemic (whole-body) treatments for their prostate cancer — beyond standard hormone-lowering therapy — including at least one newer type of anti-androgen medicine such as abiraterone, enzalutamide, apalutamide, or darolutamide.
  • People who have either had surgical removal of the testicles, or are currently receiving hormone-lowering injections or medicines that keep testosterone levels very low (below 50 ng/dL), and who are willing to continue that treatment throughout the study.

Who may not be able to join:

  • People who have bone lesions that are considered structurally unstable and at risk of fracturing.
  • People who have signs or imaging evidence of blood clots — such as a deep vein clot or a clot in the lungs — that have not been fully treated (confirm with trial site for details on prior clotting history and what treatments may allow participation).
  • People whose kidneys are not functioning well enough, based on a specific measurement of kidney filtering ability falling below a certain level.
  • People whose liver is not functioning well enough, based on blood test results for certain liver enzymes and bilirubin being above set limits (the exact limits vary depending on whether cancer has spread to the liver — confirm with trial site).
  • People whose bone marrow is not producing enough blood cells, specifically if white blood cell or platelet counts are below set levels — including specific waiting periods after certain blood-boosting medications or platelet transfusions (confirm with trial site for exact timing requirements).

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 12 July 2026
Phase 1: approximately ~10% 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.

Contact this trial

Principal Investigator: Clinical Trial Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
7 July 2026
Est. completion
5 February 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Occurrence of Treatment Emergent Adverse Events (TEAEs); Occurrence of Dose Limiting Toxicities (DLTs); Occurrence of Adverse Events of Special Interest (AESIs)

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: 12 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