OncoMatch/Clinical Trials/NCT06926634
Zanzalintinib Maintenance in Patients With High Grade Neuroendocrine Neoplasms (HG-NENs)
Is NCT06926634 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Zanzalintinib for high grade neuroendocrine neoplasms.
Treatment: Zanzalintinib — The investigators hypothesize that zanzalintinib maintenance therapy after initial cytotoxic chemotherapy can prolong the progression-free survival (PFS) in patients with high-grade NENs.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Allowed: TP53 mutation
IHC demonstrating p53 or RB mutation
Allowed: RB1 mutation
IHC demonstrating p53 or RB mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — initial course
Patients must have received their initial course of chemotherapy and be eligible for a chemotherapy break with the most recent disease imaging assessment showing stable disease (SD) or a partial response (PR) by RECIST 1.1. Patients intolerant of chemotherapy may also be eligible for the study, but they must have been treated with at least 2 cycles of chemotherapy and at least one imaging assessment on treatment or right after treatment showing PR or SD per RECIST 1.1.
Cannot have received: zanzalintinib (zanzalintinib, cabozantinib)
Prior treatment with zanzalintinib (XL092) or cabozantinib (XL184).
Lab requirements
Blood counts
ANC ≥ 1.5 K/cumm without G-CSF support; platelets ≥ 100 K/cumm without transfusion; hemoglobin ≥ 9.0 g/dL without transfusion; INR ≤ 1.5 and aPTT ≤ 1.2 x IULN
Kidney function
Creatinine ≤ 1.5 x IULN OR calculated creatinine clearance ≥ 40 mL/min by Cockcroft-Gault equation; requirement for hemodialysis or peritoneal dialysis excluded
Liver function
Total bilirubin ≤ 1.5 x IULN (≤ 3 x IULN for Gilbert's disease); AST, ALT, ALP ≤ 3.0 x IULN (ALP ≤ 5.0 x IULN with bone metastasis); moderate to severe hepatic impairment (Child-Pugh B or C) excluded
Cardiac function
QTcF ≤ 480 ms within 2 weeks per ECG before C1D1; unstable or deteriorating cardiovascular disorders excluded
Adequate bone marrow and organ function as defined below: ... (see full criteria for details); Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms within 2 weeks per electrocardiogram (ECG) before C1D1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic - Rochester · Rochester, Minnesota
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06926634 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior zanzalintinib disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages