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RECRUITINGPHASE1

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

NCT06795009•Washington University School of Medicine

Summary

The purpose of this study is to determine the recommended Phase 2 dose of zanzalintinib when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer. Other objectives include overall safety and tolerability as well as rates of response.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 such as alopecia, ≤ Grade 2 hypomagnesemia, ≤ Grade 2 neuropathy are permitted)
•Patients must have disease that cannot be managed by local therapy targeted at the tumor site (i.e. surgery, radiation therapy).
•Measurable disease by RECIST 1.1.
•At least 18 years of age.
•ECOG performance status ≤ 2.
•Adequate bone marrow and organ function within 14 days prior to first dose of study treatment, as defined below:
•* Absolute neutrophil count ≥ 1.5 K/cumm without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.
+10 more criteria

Exclusion Criteria

•Any prior treatment with zanzalintinib
•A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
•Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment, or any prior treatment with any tyrosine kinase inhibitor (TKI) or any prior treatment with bevacizumab.
•Receipt of any other (non-study) cytotoxic chemotherapy, radiation, targeted treatment, or immunotherapy (including investigational) within 4 weeks prior of start of study treatment.
•Receipt of any other investigational agents or has received an investigational agent within 4 weeks of start of study treatment.
•Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.
•Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors ) and platelet inhibitors (eg, clopidogrel).
•* Allowed anticoagulants are the following:
•* Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
•* Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.
+35 more criteria

Locations (4)

University of California, San Francisco

San Francisco, California, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

October 17, 2025

Primary Completion Date

November 30, 2029

Completion Date

April 30, 2035

Last Updated

December 11, 2025

Enrollment

ESTIMATED participants

Conditions

Uterine CancerEndometrial Cancer

Interventions

Zanzalintinib

DRUG

Paclitaxel

DRUG

Contacts

David G Mutch, M.D.

CONTACT

314-362-3181 mutchd@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

Inclusion Criteria

Exclusion Criteria

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