Phase 1 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 diagnosed with recurrent high-grade uterine or endometrial cancer (specific types: grade 3 endometrioid, serous, or mixed high-grade) or uterine carcinosarcoma, whose cancer has come back or worsened after platinum-based chemotherapy, or who could not tolerate platinum-based treatment.
• People whose tumours have certain genetic features (dMMR, MSI-H, or HER2 changes) and who have already received the appropriate targeted treatments for those features.
• People who have had 1 or 2 previous cancer treatments.
• People who have previously received trastuzumab, pembrolizumab, or dostarlimab (these count as one prior treatment if used together or as maintenance).
• People whose side effects from previous treatments have mostly resolved, or are mild and stable (confirm with trial site for specific situations).
• People whose cancer cannot be treated with surgery or radiation aimed directly at the tumour.
• People who have measurable tumours as assessed by a standard imaging method called RECIST 1.1.
• People aged 18 or older.
• People with a general health status score of 0, 1, or 2 on the ECOG scale, meaning they are able to care for themselves and are up and about for more than half of waking hours (confirm with trial site).
• People with blood counts, liver function, kidney function, and other blood test results within acceptable ranges, as confirmed by tests done within 14 days before the first dose.
• People who are not pregnant at the time of screening.
• People of childbearing potential who agree to use adequate contraception (hormonal or barrier methods, or abstinence) from before starting the trial until 186 days after the last dose, and who agree not to donate eggs during that period.
• People who are able to understand and sign a consent form, or who have a legally authorised representative to do so on their behalf.

Who may not be able to join:

• People who have previously been treated with the study drug zanzalintinib.
• People with a history of another cancer, unless all treatment for that cancer was completed at least 2 years ago and there is no current evidence of that cancer.
• People who have taken any small molecule kinase inhibitor within 2 weeks before the first dose, or who have ever previously received any tyrosine kinase inhibitor (TKI) or bevacizumab.
• People who have received other chemotherapy, radiation, targeted treatment, or immunotherapy within 4 weeks before starting the study.
• People who have taken part in another clinical trial or received an investigational drug within 4 weeks before starting.
• People who have had radiation to bone spread within 2 weeks, or other radiation within 4 weeks, before the first dose; or who have ongoing complications from prior radiation.
• People with cancer that has spread to the brain or the lining around the brain, unless it has been treated and has been stable for at least 4 weeks, and the person is not on steroid medication and has no neurological symptoms.
• People currently taking certain blood thinners or antiplatelet medicines such as warfarin, direct thrombin inhibitors, or clopidogrel (some lower-risk blood thinners may be permitted — confirm with trial site).
• People who have used herbal supplements or traditional medicines to treat their cancer within 2 weeks before the first dose.
• People with serious uncontrolled heart conditions, including severe heart failure, unstable chest pain, serious heart rhythm problems, or uncontrolled high blood pressure despite treatment.
• People who have had a stroke, mini-stroke (TIA), heart attack, or other significant arterial blood clot or circulation event within the past 6 months.
• People who have had a blood clot in the lung (pulmonary embolism) or a deep vein thrombosis (DVT) within the past 3 months (some exceptions may apply — confirm with trial site).
• People with a prior history of heart muscle inflammation (myocarditis).
• People with serious gastrointestinal conditions, such as active stomach ulcers, bowel inflammation, bowel obstruction, a fistula (abnormal connection between organs), or a perforation (hole in the bowel) within the past 6 months.
• People who have had significant bleeding (such as coughing up blood or vomiting blood) within the past 12 weeks.
• People with certain lung lesions that are causing symptoms, or tumours growing into major blood vessels.
• People with an active infection that requires treatment with systemic (whole-body) medicines.
• People with active or chronic hepatitis B or C infection, or HIV/AIDS — unless HIV is well controlled on stable treatment and specific blood count and viral load criteria are met (confirm with trial site).
• People with serious wounds, ulcers, or bone fractures that are not healing.
• People with conditions that prevent proper absorption of medicines taken by mouth (malabsorption syndrome).
• People with poorly controlled, symptomatic underactive thyroid (hypothyroidism).
• People with moderate to severe liver disease (Child-Pugh B or C).
• People who require kidney dialysis.
• People who have had a solid organ transplant or a stem cell transplant from a donor.
• People who have had major surgery within 8 weeks before the first dose, or whose surgical wounds have not fully healed.
• People whose heart electrical measurement (QTcF interval on an ECG) is above a certain threshold (confirm with trial site).
• People with a history of psychiatric illness that could interfere with their ability to follow the trial requirements or give informed consent.
• People who are pregnant or breastfeeding.
• People who are unable to swallow tablets.
• People with a known allergy to any component of the study treatment.
• People with another active cancer requiring treatment that could interfere with assessing the study drug's effect, within the past 2 years (some minor or low-grade skin cancers may be exceptions — confirm with trial site).
• People with any other condition that, in the treating doctor's opinion, would make participation unsafe or not feasible.

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