Phase 2 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 have been diagnosed with endometrial cancer confirmed by a tissue test (biopsy).
• People whose cancer has spread to other parts of the body or has grown into nearby areas, confirmed by imaging scans.
• People whose cancer can be measured or tracked on scans using a standard method called RECIST 1.1.
• People whose tumour tests positive for a protein called HER2 at certain levels (1+, 2+, or 3+) using a specific approved test.
• People who have already received at least one round of systemic (whole-body) treatment for endometrial cancer, and whose cancer has continued to grow or spread after that treatment.
• People aged 18 or older.
• People who are well enough to carry out basic daily activities, as measured by a standard scale called ECOG (score of 0, 1, or 2).
• People who have tumour tissue available from a previous biopsy, or who are willing to have a new biopsy for the study.
• People whose blood counts, liver function, kidney function, and urine protein levels meet the specific healthy ranges required by the trial (confirm with trial site for exact values).
• People who have hepatitis B, provided the virus is undetectable in their blood.
• People who have hepatitis C, provided the virus is undetectable in their blood.
• People who had brain or central nervous system tumours that have already been treated, as long as treatment (radiation or surgery) was completed more than 28 days before joining.
• People who are able to become pregnant must agree to use a highly effective form of contraception from the start of the study until 6 months after the last dose.
• People who are breastfeeding must be willing to stop breastfeeding from the start of treatment until 6 months after the last dose.
• People who are able to understand and sign a written consent form agreeing to take part.

Who may not be able to join:

• People who received certain immune-based cancer treatments (called checkpoint inhibitors, such as anti-PD-1 or anti-CTLA-4 therapies) within the 6 months before joining.
• People who previously had severe immune-related side effects (grade 3 or 4) from checkpoint inhibitor treatments.
• People who have previously been treated with a drug called Lenvatinib.
• People who have had a serious allergic reaction to drugs similar to those used in this trial.
• People who had surgery to the abdomen, pelvis, or chest within 3 months before joining.
• People who have been diagnosed with another cancer within the past 24 months (though some exceptions may apply for certain treated skin cancers or in-situ cancers — confirm with trial site).
• People who had a blood clot in an artery or vein within the 6 months before joining.
• People who had a stroke or mini-stroke (TIA) within the 6 months before joining.
• People with significant heart failure that affects daily functioning, based on a standard heart health scale (NYHA Class III or IV).
• People with a specific abnormal heart rhythm reading on an ECG, or evidence of a serious type of heart block.
• People whose heart pumping strength (ejection fraction) is below 50% on an echocardiogram (heart ultrasound).
• People who are currently taking blood-thinning medications such as warfarin, heparin, or similar drugs.
• People with a history of a serious abnormal connection (fistula) between body organs or tissues (grade 3 or higher).
• People whose scans show cancer growing into major blood vessels.
• People who have coughed up blood or had tumour-related bleeding within 1 month before joining.
• People with conditions affecting how the gut absorbs medication, including certain gut surgeries or disorders.
• People with a primary immune system deficiency condition.
• People with an active autoimmune disease, or a history of autoimmune disease that requires immune-suppressing medications (confirm with trial site for possible exceptions, such as vitiligo or hormone replacement conditions).
• People who have been taking corticosteroid medicines at doses higher than a low maintenance level within 14 days before joining (topical creams, eye drops, and ointments are generally allowed — confirm with trial site).
• People who have received an organ transplant or a stem cell transplant from a donor.
• People who are HIV-positive.
• People who are pregnant.
• People with other serious uncontrolled health conditions that would make it difficult to follow the trial requirements.

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