Clinical Trial

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Recruiting Phase 1
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Summary
This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-03-28; most recent amendment 2025-12-01.
Status change: Active, Not Recruiting → Recruiting 2025-12-01
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-10-14
Trial Details
NCT Number NCT06912087
Lead Sponsor University of Chicago
Collaborators: Exelixis
Conditions Head and Neck Neoplasms, Carcinoma, Squamous Cell, Neoplasm Recurrence, Local, Neoplasm Metastasis, Recurrent Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma
Enrollment 36 participants
Start Date 2025-09-29
Primary Completion 2027-06-05 (estimated)
Study Completion 2027-06-05 (estimated)
Updated on ClinicalTrials.gov 2025-12-02