Phase 3 Endometrial Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 18 years old and meet the legal age of consent in the country where the trial is taking place.
• People who have been diagnosed with endometrial cancer (cancer of the lining of the uterus), confirmed by a laboratory test on a tissue sample — including types such as endometrioid, serous, clear cell, carcinosarcoma, or mixed types.
• People who have had at least 1 but no more than 2 previous rounds of systemic treatment (medication that travels through the body) for their endometrial cancer, or up to 3 rounds if one of those was given before or after surgery to prevent recurrence (confirm with trial site for how previous treatment lines are counted).
• People who have been previously treated with platinum-based chemotherapy and have also received a type of immunotherapy called a PD-1 or PD-L1 inhibitor (either together or separately), or people whose doctor determined they were not suitable for PD-1/PD-L1 therapy due to a medical reason such as an immune condition.
• People whose cancer returned within less than 12 months after finishing platinum-based chemotherapy given after surgery — or people who received PD-1/PD-L1 therapy alongside platinum chemotherapy, or who had metastatic disease treated with platinum, or who could not tolerate platinum (confirm with trial site for specific eligibility under this criterion).
• People who are able to provide a stored tumor tissue sample (a type called formalin-fixed, paraffin-embedded) that is sufficient for testing a specific protein called B7-H4, with results available before the trial assignment date.
• People who have at least one measurable area of cancer that can be tracked on scans, as assessed by the trial's imaging review process.
• People who are willing to use effective contraception as required by local regulations and the trial protocol.
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or who agree to use highly effective contraception (with a failure rate of less than 1% per year) starting at least 30 days before the first treatment dose, throughout the trial, and for at least 8 months after the last dose — and who agree not to donate eggs during this period.
• Women who could potentially become pregnant must have a negative pregnancy test within 24 hours before the first dose.
• People who are able to understand and sign an informed consent form and follow the trial's requirements.
• People with a general health status rated as 0 or 1 on the ECOG scale, meaning they are either fully active or have minor restrictions but are able to carry out light activity (confirm with trial site).
• People whose liver, kidneys, and other organs are functioning at an adequate level as assessed by blood tests.

Who may not be able to join:

• People whose uterine cancer is classified as a mesenchymal tumour (uterine sarcoma) or a neuroendocrine type.
• People who have had another type of cancer (other than the endometrial cancer being studied) that was active or required treatment within the past 3 years — unless it was a non-spreading skin cancer or an in-situ cancer (confined to one area) that was fully removed, or is otherwise considered cured by the treating doctor.
• People who have had a bone marrow transplant or solid organ transplant at any point in the past.
• People who have a known allergy or sensitivity to the study drug or its ingredients that, in the doctor's opinion, makes participation unsafe.
• People who have untreated cancer spread to the brain or central nervous system, or brain/CNS metastases that have grown or caused new symptoms — though people with previously treated and stable brain metastases who have not needed steroid treatment for at least 14 days before the trial starts may still be eligible (confirm with trial site).
• People who currently have, or have previously had, a lung condition called interstitial lung disease or non-infectious pneumonitis (inflammation of the lungs).
• People who still have side effects from previous cancer treatment that have not returned to a mild or baseline level, with some exceptions such as hair loss, hearing changes, or certain hormone-related conditions being managed with medication.
• People with any serious unstable medical condition, serious psychiatric condition, or significant abnormal test results that could affect their safety or ability to participate.
• People who have had major surgery within 28 days before the trial starts, or local radiotherapy within 21 days before the trial starts.
• People who have received another experimental (investigational) treatment within 30 days before the trial starts.
• People who have previously been treated with a class of chemotherapy drugs called topoisomerase 1 inhibitors (such as irinotecan or topotecan), or with an antibody-drug conjugate carrying that type of payload, or with any therapy targeting the B7-H4 protein.
• People who have received chemotherapy, immunotherapy, hormone therapy, targeted therapy, or other anti-cancer treatments within 30 days or 5 half-lives (whichever is shorter) before the trial starts.
• People who have received a live vaccine within 30 days before the trial starts (note: mRNA and adenoviral COVID-19 vaccines are not considered live vaccines).
• People who have taken certain medications that affect how the body processes drugs (specifically inhibitors of P-gp, BCRP, or OATP1B1/1B3 transporters) within 7 days before the trial starts, or certain other drugs called P-gp inducers within 14 days before the trial starts (confirm specific medications with trial site).
• People who have had a blood transfusion or received blood cell growth-stimulating injections (such as G-CSF or erythropoietin) within 14 days before the trial starts.
• People with a known HIV infection who also meet certain additional conditions related to HIV viral levels, immune cell counts, recent changes to HIV medication, or history of certain HIV-related cancers (confirm with trial site for specific details).
• People with certain abnormal liver test results, including elevated liver enzymes (ALT) or bilirubin above specified levels.
• People with cirrhosis or unstable liver or bile duct disease, including symptoms such as fluid build-up in the abdomen, confusion related to liver disease, or persistent yellowing of the skin.
• People who test positive for Hepatitis B surface antigen or Hepatitis B core antibody at screening, unless they are already on effective antiviral treatment and their Hepatitis B viral levels are well controlled (confirm with trial site).
• People who test positive for Hepatitis C antibodies or active Hepatitis C virus in their blood, unless past infection has fully resolved.
• People with a heart rhythm measurement (QTc interval) greater than 470 milliseconds on an ECG.
• People who have had a significant or uncontrolled heart condition within the past 12 months, including a heart attack, severe heart failure, or a serious abnormal heart rhythm not controlled by standard treatment.
• People whose heart pumping function (left ventricular ejection fraction) is below 50% or below the normal range used by the trial site.
• People with any active kidney condition, including infection, the need for dialysis, or any other significant kidney problem that could affect safety.

Important: Always verify eligibility with the trial site directly before applying.