Phase 2 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 have been diagnosed with endometrial cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer (NSCLC), or sarcoma, confirmed by a laboratory test on a tissue or cell sample
• People whose cancer has spread, cannot be surgically removed, and/or is at an advanced stage, and whose tumour has a specific HER2 protein overexpression (for endometrial, colorectal, head and neck cancers, or sarcoma) or a specific HER2 gene change (for NSCLC), confirmed through tumour testing
• People aged 18 or older at the time of joining
• People whose general physical condition is reasonably functional, rated on a standard medical scale (ECOG score of 0, 1, or 2 — meaning able to carry out at least some daily activities) (confirm with trial site)
• People whose cancer has continued to grow after at least one previous treatment, and for whom no other standard treatment options remain
• People whose HER2 alteration is covered by an existing approved HER2-targeted treatment, but only after those standard HER2-targeted treatments have already been tried and have stopped working
• People with an estimated life expectancy of more than 3 months
• People who have at least one measurable area of cancer that can be tracked using standard imaging measurements (RECIST 1.1 criteria), including in areas that were previously treated with radiation if the cancer has clearly grown there
• People whose blood counts meet minimum thresholds (sufficient white blood cells, platelets, and haemoglobin levels — blood transfusions are permitted, with at least a 2-week gap before starting treatment)
• People whose liver function blood test results fall within acceptable ranges set by the trial
• People whose heart is pumping at least 50% of its normal capacity, confirmed by a heart scan done within 14 days before joining
• People whose blood clotting tests are within normal range (unless already taking blood-thinning medication)
• People whose kidneys are functioning at a sufficient level based on a standard calculation using a blood test result
• People of any gender who agree to use highly effective contraception throughout the trial and for the required period after treatment ends; men must also agree not to donate sperm, and women must agree not to donate eggs during that time
• Women who could potentially become pregnant must have a negative blood pregnancy test done within 3 days before starting treatment
• People who can provide a suitable stored tumour tissue sample (preserved in a specific way, ideally less than 2 years old, and no more than 5 years old), or who agree to an optional new biopsy for the study (certain sample types are not acceptable — confirm with trial site)
• People who are willing and able to follow all trial requirements, including appointments, tests, and sample collection
• People who are enrolled in a social security system (confirm with trial site — this criterion may reflect a France-specific requirement)
• People who have signed a written consent form before any trial procedures begin; if someone is physically unable to sign, a trusted person of their choice (independent from the research team) may sign on their behalf

Who may not be able to join:

• People who, in the treating doctor's judgement, would be better suited to another currently recruiting trial testing an anti-HER2 therapy (including the study drug zanidatamab)
• People who have previously received a HER2-targeted treatment, unless that treatment is a standard approved therapy for the specific cancer type being studied in this trial
• People who have had another separate cancer diagnosis within the past 3 years — exceptions may apply for certain early-stage or fully treated skin cancers, or for people who completed potentially curative treatment for a prior cancer, have had no sign of that cancer for 4 or more years, and are considered at very low risk of it returning (confirm with trial site)
• People who have an autoimmune, connective tissue, or inflammatory condition that affects the lungs (such as rheumatoid arthritis or sarcoidosis), unrelated to lung metastases
• People who have had a full surgical removal of one lung (pneumonectomy)
• People who have any serious uncontrolled medical condition — such as active bleeding, active infection, or severe psychiatric illness — that the treating doctor believes would make participation unsafe or make it difficult to follow the trial requirements
• People who have had a heart attack or unstable chest pain within the past 6 months, have certain abnormal heart enzyme levels, or have significant heart conditions such as uncontrolled high blood pressure, serious irregular heart rhythms, or a history of symptomatic heart failure
• People with active, symptomatic brain metastases or spinal cord compression that require treatment with steroids or anti-seizure medications; people with treated and stable brain metastases that are not causing symptoms and have not shown signs of growth for at least 2 weeks before starting the study drug may be eligible (confirm with trial site)
• People with cancer that has spread to the lining surrounding the brain and spinal cord (leptomeningeal disease) and is causing neurological symptoms
• People with uncontrolled acute or chronic pancreas inflammation, or severe liver disease (classified as Child-Pugh Class C)
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild or baseline level (with the exception of hair loss); people with ongoing moderate side effects may be considered at the treating doctor's discretion after discussion with the lead investigator
• People who have been taking high-dose steroid tablets or other immune-suppressing medications within the 2 weeks before starting the study drug (certain inhaled, topical, or local steroid treatments may still be permitted — confirm with trial site)
• People who have received a specific class of chemotherapy drugs called anthracyclines within the 90 days before starting the study drug, or who have received a total lifetime dose above a set threshold (confirm with trial site)
• People who have had a serious, life-threatening allergic reaction to similar types of biological medicines (monoclonal antibodies or recombinant proteins) in the past
• People who are pregnant or currently breastfeeding
• People who have participated in another treatment trial within the 30 days before joining this study (participation in an observational study — where no treatment is given — would generally be acceptable)
• People who are unable or unwilling to attend the required medical follow-up visits due to personal, geographic, family, or psychological reasons
• People who are currently detained or under a legal guardianship or protective custody arrangement

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