Phase 2 Endometrial Cancer Trial, Recruiting NCT05768139 Sponsor: Eli Lilly and Company Condition: Endometrial Cancer
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Phase 2 Endometrial Cancer Trial, Recruiting

NCT05768139
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 an advanced, spreading, or inoperable solid tumour cancer (the specific type depends on which group within the trial a person is assigned to)
  • People who have a recent tumour biopsy available, or who are able to provide a suitable tissue sample before or at the start of the screening process
  • People whose tumour has a specific genetic change (mutation) in a gene called PI3Kα (the exact mutation type required depends on the trial group)
  • People who are 18 years of age or older at the time of signing the consent form
  • People who have a good general level of physical functioning, rated 0 or 1 on a standard medical scale called the ECOG scale — meaning the person is fully active or able to carry out light activity (confirm with trial site)
  • People whose liver, kidneys, and other organs are functioning well enough to meet the trial's requirements

Who may not be able to join:

  • People who have been diagnosed with a different type of cancer (either a solid tumour or a blood cancer) within the past 2 years
  • People who currently have brain or spinal cord spread of their cancer that is causing symptoms
  • People who have diabetes that is not well controlled, based on specific blood sugar or insulin use measures (confirm with trial site for exact thresholds)
  • People who have previously been treated with a type of cancer drug that targets the PI3K, AKT, or mTOR pathways — though there may be some exceptions (confirm with trial site)
  • People who have received cancer treatment — either standard or experimental — within approximately 14 days or longer before starting the trial (a specific calculation applies; confirm with trial site). Note: some hormone-based therapies may not require a break in treatment depending on the trial group
  • People who still have significant side effects remaining from previous cancer treatments that have not returned to near-normal levels, with the exception of hair loss or nerve-related symptoms in the hands or feet
  • People who have had radiation therapy within 14 days before the trial treatment would begin

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 6 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: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

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
Registry
ClinicalTrials.gov
Start date
17 April 2023
Est. completion
1 July 2030

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Number of participants who experience at least 1 Dose Limiting Toxicity (DLT); Proportion of participants who experience at least 1 DLT during the first 28 days of treatment; Objective response rate (ORR) defined as the percentage of participants with partial response or complete response based on RECIST 1.1; Incidence of TEAEs/SAEs ≥ grade 2; Frequency of TEAEs according to CTCAE v5.0 criteria

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: 6 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