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

NCT06912087 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-02

No results posted yet for this study

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).

Conditions

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Recurrent Squamous Cell Carcinoma
  • Metastatic Squamous Cell Carcinoma

Interventions

DRUG

Zanzalintinib

Experimental receptor tyrosine kinases (RTKs)

DRUG

Cetuximab

Food and Drug Administration (FDA) approved monoclonal antibody directed against the epidermal growth factor (EGFR).

DRUG

Pembrolizumab

FDA approved monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1)

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Ari Rosenberg, MD · University of Chicago Medicine Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2027-06-05
Completion
2027-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912087 on ClinicalTrials.gov