Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer
Phase I/IB Study of Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer
Sponsor: Washington University School of Medicine + National Cancer Institute (NCI), Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Recommended Phase 2 dose (RP2D)
Time frame: Through completion of first cycle (each cycle is 21 days) of all enrolled patients (estimated to be 48 months and 3 weeks)
Secondary Endpoints
Frequency and severity of treatment-emergent adverse events
Overall response rate (ORR)
Progression-free survival (PFS)
Eligibility Criteria
Inclusion Criteria: * Diagnosis of recurrent, FIGO grade 3 endometrioid, serous, or mixed high grade uterine or endometrial cancer or uterine carcinosarcoma. Patients must have experienced either prior progression on a platinum-based therapy or intolerance to platinum. Patients with dMMR or MSI-H tumors or targetable HER2 alterations are required to have received prior therapy with appropriate targeted agents. * 1-2 prior lines of anti-cancer therapy are allowed. * Subjects who have received prior treatment with trastuzumab, pembrolizumab, or dostarlimab can enroll in the study. Use of these agents together or as maintenance therapy is considered 1 regimen. * Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (eg, physiological replacement of corticosteroid). Low-grade or controlled toxicities suc…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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