Actively Recruiting
Zanzalintinib Maintenance in Patients With High Grade Neuroendocrine Neoplasms (HG-NENs)
Led by Washington University School of Medicine · Updated on 2025-12-17
32
Participants Needed
2
Research Sites
472 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators hypothesize that zanzalintinib maintenance therapy after initial cytotoxic chemotherapy can prolong the progression-free survival (PFS) in patients with high-grade NENs.
CONDITIONS
Official Title
Zanzalintinib Maintenance in Patients With High Grade Neuroendocrine Neoplasms (HG-NENs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed high-grade poorly differentiated or well differentiated neuroendocrine tumor with Ki-67 ≥20%, excluding small cell lung cancer and Merkel cell cancer
- Measurable disease per RECIST 1.1 criteria
- Current or prior somatostatin analogue therapy allowed if clinically indicated
- Received initial chemotherapy and eligible for chemotherapy break with stable disease or partial response on recent imaging
- Patients intolerant of chemotherapy must have had at least 2 cycles and an imaging assessment showing stable disease or partial response
- At least 18 years of age
- ECOG performance status ≤ 2 (Karnofsky ≥ 80%)
- Adequate bone marrow and organ function as specified (ANC ≥ 1.5 K/cumm, platelets ≥ 100 K/cumm, hemoglobin ≥ 9.0 g/dL, INR ≤ 1.5, aPTT ≤ 1.2 x IULN, total bilirubin ≤ 1.5 x IULN or ≤ 3 x IULN for Gilbert's disease, AST/ALT/ALP ≤ 3.0 x IULN or ALP ≤ 5.0 x IULN if bone metastasis present, creatinine ≤ 1.5 x IULN or creatinine clearance ≥ 40 mL/min, urine protein-to-creatinine ratio ≤ 1 mg/mg)
- Recovery to baseline or ≤ Grade 1 severity from prior adverse events except for controlled low-grade toxicities
- Sexually active fertile subjects and partners must agree to use highly effective contraception during and after study treatment
- Female subjects of childbearing potential must not be pregnant at screening
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with zanzalintinib or cabozantinib
- Another active malignancy requiring therapy within 2 years before study start, except certain low-grade or localized tumors
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
- Recent use of kinase inhibitors or systemic anticancer therapy within specified timeframes before study
- Recent radiation therapy within specified periods
- Use of complementary medications for disease within 2 weeks before study
- Use of strong or moderate CYP3A4 inhibitors or inducers within 4 half-lives before study
- Use of medications known to prolong QT interval within 4 half-lives before study
- Concomitant anticoagulation with oral anticoagulants and platelet inhibitors except specified exceptions
- Allergic reactions to similar compounds as zanzalintinib
- Uncontrolled significant illnesses including severe cardiovascular disorders, gastrointestinal disorders with high risk, significant bleeding, symptomatic pulmonary lesions, lesions invading major blood vessels
- Active infection requiring systemic treatment or certain infections including hepatitis B, C, or uncontrolled HIV/AIDS
- Serious non-healing wounds, malabsorption syndrome, uncompensated hypothyroidism, moderate to severe hepatic impairment, dialysis requirement, history of transplantation
- Major surgery within 8 weeks or minor surgery within 5 days before study
- QTcF > 480 ms within 2 weeks before study
- Psychiatric illness interfering with study compliance
- Inability to swallow tablets or suspensions
- Pregnant or breastfeeding women
- Other conditions deemed unsafe by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
N
Nikolaos Trikalinos, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here