Phase 1 Prostate Cancer Trial, Recruiting NCT05488548 Sponsor: Epigenetix, Inc. Condition: Prostate Cancer
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Phase 1 Prostate Cancer Trial, Recruiting

NCT05488548
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:

  • You have prostate cancer that has stopped responding to hormone therapy and has come back or not responded to at least one anti-androgen treatment and a chemotherapy regimen containing docetaxel.
  • You have a rare cancer called NUT midline carcinoma that has spread or cannot be removed by surgery, and no standard treatments are available.
  • You have a blood condition called CMML (a type of bone marrow cancer) that has come back or stopped responding after at least 4 cycles of certain standard treatments (or fewer if you could not tolerate them or your disease got worse).
  • You have an advanced form of myelofibrosis (a bone marrow disease, intermediate or high-risk) that did not respond to, or is not suitable for, a type of drug called a JAK inhibitor.
  • You have advanced myelofibrosis (intermediate or high-risk) with a low level of abnormal cells in your blood, and a JAK inhibitor stopped working after at least 3 months of treatment.
  • You have another type of cancer (solid tumor or blood cancer) that the trial doctors believe may respond to this experimental treatment, after review and approval by the medical team.
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site).
  • Your doctors expect you to live at least 3 months or more.
  • Your disease can be measured or evaluated during the trial.
  • Your blood counts meet minimum levels — for example, enough red blood cells, infection-fighting cells, and platelets (specific numbers will be checked by the trial team).
  • Your kidneys are working well enough to filter your blood adequately.
  • Your liver is working within acceptable limits based on blood tests.
  • Your blood clotting is within a normal range (if you are not on long-term blood thinners).
  • At least 4 weeks have passed since your last cancer treatment (such as chemotherapy or immunotherapy), or an appropriate amount of time has passed since targeted therapy or radiation, and any side effects from previous treatment have mostly resolved.
  • At least 4 weeks have passed since any major surgery.
  • If you are able to have children, you agree to use effective birth control during the study and for 4 weeks after your last dose.
  • You are able to understand and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

  • You have brain or spinal cord cancer that is new or getting worse (however, if brain metastases were previously treated and have been stable for at least 4 weeks, you may still be eligible — confirm with trial site).
  • You have a heart condition that causes an abnormally long electrical signal in your heart, shown on an ECG test (confirm with trial site).
  • You have serious uncontrolled health problems, such as an active infection requiring IV antibiotics or antifungal medication, severe heart failure, unstable chest pain, irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow the study requirements.
  • You are currently pregnant or breastfeeding.
  • You have a known history of hepatitis B or hepatitis C that requires antiviral treatment.
  • You are living with HIV and your virus is not fully controlled (note: if you are on effective HIV treatment and your viral levels have been undetectable for the past 6 months, you may still be eligible — confirm with trial site).

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 15 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: Judy Chiao, MD, Epigenetix, Inc.

Phone: (561) 865-6098

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
Epigenetix, Inc.
Registry
ClinicalTrials.gov
Start date
21 December 2022
Est. completion
1 May 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD); Dose Limiting Toxicities (DLT); Recommended Phase 2 Dose (RP2D)

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: 15 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