Study on Zanzalintinib Maintenance Therapy for Patients with High-Grade Neuroendocrine Tumors

Inclusion Criteria

• Diagnosed with high-grade neuroendocrine tumors, excluding small cell lung cancer and Merkel cell cancer.
• Tumors must have a specific growth rate (Ki-67 of 20% or higher) or other markers indicating high-grade status.
• Must have measurable disease according to standard criteria.
• Can have received somatostatin analogue therapy for well-differentiated high-grade tumors.
• Must have completed initial chemotherapy and be eligible for a break, with recent imaging showing stable disease or partial response.
• Must be 18 years or older.
• Must be in good general health with a performance status score of 0 or 1.
• Must have adequate blood cell counts and organ function based on specific lab tests.
• Must have recovered from any side effects of previous treatments to a mild level.
• Must agree to use effective contraception during the study and for a specified period after the last dose.
• Women must not be pregnant and must meet specific criteria to be considered not of childbearing potential.
• Must be able to understand and sign a consent form.

Exclusion Criteria

• Previous treatment with zanzalintinib or cabozantinib.
• Another active cancer that could interfere with the study, except for certain low-risk cancers.
• Untreated or unstable brain metastases.
• Recent use of certain cancer drugs within two weeks before starting the study.
• Use of certain blood thinners that are not allowed.
• History of severe allergic reactions to similar drugs.
• Uncontrolled or serious health conditions, including heart problems, recent strokes, or blood clots.
• Gastrointestinal issues that could increase risk of complications.
• Significant bleeding issues or recent major surgery.
• Active infections or certain viral infections unless well-controlled.
• Other conditions that could make participation unsafe or interfere with the study.