Phase 2 Endometrial Cancer Trial, Recruiting NCT05997017 Sponsor: Aadi Bioscience, Inc. Condition: Endometrial Cancer
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Phase 2 Endometrial Cancer Trial, Recruiting

NCT05997017
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:

  • People who have been diagnosed with advanced or returning endometrioid endometrial cancer (a specific type of uterine cancer) that has been confirmed by a doctor.
  • People who have at least one measurable area of cancer that can be seen on a CT scan or MRI scan.
  • People whose cancer has spread or cannot be removed by surgery without causing serious harm.
  • People who have received either no chemotherapy, or no more than one course of chemotherapy for advanced or returning cancer, with the most recent chemotherapy completed at least 3 months before joining (previous chemotherapy given after initial surgery is also counted, with certain limits).
  • People who have received non-chemotherapy treatments (such as immunotherapy or hormone therapy) at any point, as long as those treatments ended at least 4 weeks before joining.
  • People whose cancer previously responded (shrank or disappeared) to at least one prior treatment, if any prior treatment was received for advanced or returning disease.
  • People aged 18 or older.
  • People who are generally well enough to carry out light activity and care for themselves (confirm with trial site for the specific fitness level required).
  • People whose liver, kidney, and blood cell levels meet certain minimum thresholds on testing (the trial site will check these).
  • People whose fasting blood fat levels (triglycerides and cholesterol) are within acceptable ranges on testing.
  • People who have recovered from previous treatments or surgeries, with at least 4 weeks having passed since major surgery, radiation, or most prior cancer treatments.
  • People who are not pregnant and not breastfeeding, and who agree to use effective contraception from 28 days before starting treatment until 3 months after the last dose, and who agree to regular pregnancy testing throughout the study.
  • People who are willing and able to attend scheduled visits and follow study procedures.
  • People with a known history of HIV may be eligible if they have had no AIDS-related infections in the past 12 months, have been on a stable HIV treatment regimen for at least 4 weeks with a very low viral count, and whose HIV medications do not interact strongly with the study drug.

Who may not be able to join:

  • People who have previously been treated with an mTOR inhibitor, including the study drug nab-sirolimus.
  • People with certain specific genetic changes (TSC1 or TSC2 mutations) found in tumour or blood testing, unless a related study has closed to new participants (confirm with trial site).
  • People currently experiencing a serious active infection requiring antibiotic or antifungal treatment, or who completed such treatment within the last 7 days.
  • People whose cancer has never responded to any prior treatment (meaning it never shrank or disappeared with previous therapy).
  • People with known or suspected cancer spread to the brain.
  • People with serious heart conditions, including severe heart failure, unstable chest pain, a heart attack within the last 6 months, or serious uncontrolled heart rhythm problems.
  • People with severe lung disease, including significantly reduced lung function or low blood oxygen levels at rest.
  • People with other serious uncontrolled medical conditions that could be made worse by the study treatment.
  • People with a history of another cancer within the past 5 years, unless it was a type that may be considered acceptable after discussion with the medical team (such as certain skin cancers, some early-stage cancers, or certain low-grade blood cancers — confirm with trial site).
  • People with uncontrolled high blood pressure (blood pressure consistently at or above 160/100 mmHg).
  • People with a history of scarring or inflammation of the lungs (interstitial lung disease, pneumonitis) or high blood pressure in the lungs.
  • People with active hepatitis B or hepatitis C infection with a detectable viral level despite antiviral treatment.
  • People who need to take certain medications that strongly interact with the study drug (including some antifungals and antibiotics such as ketoconazole, itraconazole, erythromycin, clarithromycin, rifampin, and others) — these medications would need to be stopped before starting the study drug (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 26 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.

Contact this trial

Principal Investigator: Willis Navarro, MD, Aadi Bioscience

Phone: 1-888-246-2234

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 2
Sponsor
Aadi Bioscience, Inc.
Registry
ClinicalTrials.gov
Start date
28 December 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall response rate (ORR)

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: 26 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