Phase 1 Endometrial Cancer Trial, Recruiting NCT05542407 Sponsor: UNC Lineberger Comprehensive Cancer Center Condition: Endometrial Cancer
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Phase 1 Endometrial Cancer Trial, Recruiting

NCT05542407
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 are able to understand and are willing to sign a consent form agreeing to take part in the study.
  • You are 18 years of age or older at the time of signing consent.
  • You are able to carry out daily activities with little to no limitation, or only moderate limitation (confirm with trial site what this means for your situation).
  • You have been diagnosed with a type of endometrial (uterine) cancer that has spread or come back, confirmed by a tissue sample, including several specific types of this cancer.
  • You have at least one area of cancer in your body that can be measured by scans.
  • Your cancer has continued to grow or spread after at least one round of chemotherapy for advanced disease, or it came back within 12 months of finishing chemotherapy given after surgery.
  • You are expected to live for at least 3 months.
  • Your liver, kidneys, blood, and other organs are functioning well enough, as confirmed by blood tests taken within 72 hours before starting the study treatment.

Who may not be able to join:

  • You have previously been treated with a drug called ONC201.
  • You have previously received certain types of cancer immunotherapy treatments, including specific types that target the immune system (confirm with trial site which treatments apply).
  • You have taken part in another clinical trial or received an experimental treatment within the last 28 days.
  • You have had chemotherapy or radiation therapy within the last 4 weeks, or you are still experiencing side effects from a previous cancer treatment.
  • You have taken antibiotic tablets or IV antibiotics to treat an infection within the last 2 weeks (note: antibiotics taken to prevent infection, such as for urinary tract infections, may still be acceptable — confirm with trial site).
  • You have received certain medicines that stimulate the immune system within the last 4 weeks or 5 half-lives of the drug, whichever is longer (confirm with trial site which medicines apply).
  • You have taken medicines that suppress the immune system, such as steroids or certain other drugs, within the last 2 weeks (confirm with trial site which medicines apply).

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 27 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: Victoria Bae-Jump, MD, PhD, UNC-Chapel Hill

Phone: 919-966-1195

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
UNC Lineberger Comprehensive Cancer Center
Registry
ClinicalTrials.gov
Start date
23 October 2023
Est. completion
21 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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: 27 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