Phase 1 Prostate Cancer Trial, Recruiting NCT05818683 Sponsor: Janssen Research & Development, LLC Condition: Prostate Cancer
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Phase 1 Prostate Cancer Trial, Recruiting

NCT05818683
Recruiting Phase 1 🇦🇺 Australian site

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 metastatic prostate cancer that no longer responds to hormone therapy (called castration-resistant prostate cancer, or mCRPC), confirmed by a tissue biopsy, depending on which part of the trial you are being considered for
  • For some parts of the trial, your cancer must show a PSA level of at least 2 ng/mL (a specific protein measured in a blood test)
  • For one specific part of the trial (Part 2H), you have metastatic prostate cancer that still responds to hormone therapy, with a PSA above 0.2 ng/mL, and you have been on certain hormone-blocking treatments for 6 to 24 months
  • Your cancer can be measured or tracked on scans (except for one specific part of the trial)
  • You have already received at least one previous hormone-blocking treatment (such as abiraterone, apalutamide, enzalutamide, or darolutamide), and depending on the part of the trial, possibly chemotherapy as well
  • You are generally in good physical health and able to carry out daily activities with no or minimal limitations (confirm with trial site)
  • Your kidneys, liver, and other organs are working well enough to safely receive treatment

Who may not be able to join:

  • You have had an active autoimmune disease (where the immune system attacks the body) in the past 12 months that required medication to suppress the immune system
  • You still have significant side effects from previous cancer treatments that have not returned to mild or pre-treatment levels (hair loss, skin colour changes, or mild nerve problems may be exceptions)
  • You have had a solid organ transplant (such as a kidney or liver) or a bone marrow transplant
  • You have a known allergy or intolerance to any of the study drugs being used in the part of the trial you would be joining
  • You have a serious active infection, or significant lung, heart, or other major medical conditions

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 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
26 April 2023
Est. completion
31 August 2027

Where this trial is recruiting

🇦🇺 Australia 🇪🇸 Spain 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: Number of Participants With Dose Limiting Toxicity (DLT); Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

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