Actively Recruiting
Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer
Led by Washington University School of Medicine · Updated on 2025-12-11
36
Participants Needed
4
Research Sites
497 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent, FIGO grade 3 endometrioid, serous, or mixed high-grade uterine or endometrial cancer or uterine carcinosarcoma
- Prior progression on platinum-based therapy or intolerance to platinum
- Prior therapy with targeted agents for dMMR, MSI-H tumors, or HER2 alterations
- 1-2 prior lines of anti-cancer therapy allowed
- Prior treatment with trastuzumab, pembrolizumab, or dostarlimab allowed
- Recovery to baseline or 4 Grade 1 severity from prior treatment adverse events
- Disease not manageable by local therapy such as surgery or radiation
- Measurable disease by RECIST 1.1
- At least 18 years old
- ECOG performance status 4 2
- Adequate bone marrow and organ function within 14 days prior to first dose
- Female subjects of child-bearing potential must not be pregnant and agree to use contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with zanzalintinib
- History of other malignancy treated within 2 years except certain cured tumors
- Recent treatment with kinase inhibitors, bevacizumab, chemotherapy, radiation, targeted or immunotherapy within specified timeframes
- Recent use of investigational agents within 4 weeks
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks
- Known brain metastases unless treated and stable for at least 4 weeks
- Use of oral anticoagulants or platelet inhibitors except certain allowed anticoagulants
- Use of complementary medications to treat the disease within 2 weeks
- Uncontrolled significant illnesses including serious cardiovascular disorders, gastrointestinal disorders with high risk of perforation, symptomatic bleeding, or infections
- Major surgery within 8 weeks prior to first dose
- QTcF > 480 ms within 14 days before first dose
- Psychiatric illness interfering with study compliance
- Pregnant or lactating females
- Inability to swallow tablets
- Allergy or hypersensitivity to study treatment components
- Other conditions compromising safety or ability to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
3
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Not Yet Recruiting
4
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
Research Team
D
David G Mutch, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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