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:

• Women aged 18 or older (or the minimum age allowed by local rules) who are willing to give informed consent to participate.
• People with a confirmed diagnosis of endometrial cancer that has come back (recurred), based on tissue testing.
• People whose cancer has a specific protein level on its cells called HER2, measured as 1+ or 2+ (Cohort 1) or 3+ (Cohort 2), confirmed by a central laboratory.
• People whose cancer is not classified as a true sarcoma (such as leiomyosarcoma or endometrial stromal sarcoma) — though uterine carcinosarcoma is allowed.
• People whose cancer can be measured using standard imaging guidelines (called RECIST v1.1).
• People who are reasonably active and able to care for themselves, rated 0, 1, or 2 on a standard activity scale (ECOG Performance Status).
• People whose cancer came back less than 12 months after finishing platinum-based chemotherapy given after surgery for Stage I to III disease, OR whose cancer came back after receiving platinum-based chemotherapy for advanced or metastatic disease.
• People who have previously been treated with a type of immunotherapy called an immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1 therapy).
• People expected to live at least 12 weeks at the time of screening.

Who may not be able to join:

• People in Cohort 1 whose doctors determine they are not suitable for any of the chemotherapy options available in that part of the trial, based on local medical guidelines.
• People who have been hospitalised for a small bowel blockage within the past 3 months before starting treatment.
• People with an uncontrolled ongoing illness that could make it difficult to follow the trial requirements or that could significantly increase the risk of serious side effects.
• People with uncontrolled fluid build-up around the lungs, abdomen, or heart that required draining, or who have had a shunt placed in the abdomen, within the 2 weeks before starting treatment.
• People with a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that needed steroid treatment, people currently experiencing this condition, or people where this condition cannot be ruled out on imaging at screening.
• People who have taken immune-suppressing medications within 14 days before starting treatment — with some exceptions, such as low-dose steroid creams, nasal sprays, inhalers, or very low-dose oral steroids (confirm with trial site for exact thresholds).
• People with significant ongoing lung conditions, including (but not limited to) a blood clot in the lungs within the past 3 months, severe asthma, significant chronic obstructive pulmonary disease, lung scarring, or certain autoimmune conditions affecting the lungs — or people who have had a complete surgical removal of one lung.
• People with an active, uncontrolled infection requiring antibiotics, antiviral, or antifungal medicines within 2 weeks before starting treatment.
• People who still have unresolved side effects from previous cancer treatments (apart from hair loss, fatigue, or well-controlled hormone-related effects) that have not returned to a mild or baseline level.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 7 months after the last dose of treatment.
• People with a known allergy or intolerance to the study drugs or similar antibody-based medicines — unless they have successfully completed a medical desensitisation process and are able to tolerate the drug.
• People who have previously been treated with a type of drug called a topoisomerase I inhibitor, including certain targeted drug-antibody combinations (antibody-drug conjugates or ADCs).
• People whose heart pumping function (left ventricular ejection fraction) is below 55%, or who have a specific measure of heart pressure above a certain threshold, based on a heart scan done within 28 days before starting treatment.

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