OncoMatch/Clinical Trials/NCT06926634
Zanzalintinib Maintenance in Patients With High Grade Neuroendocrine Neoplasms (HG-NENs)
Is NCT06926634 recruiting? Yes, currently enrolling (May 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
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 →
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