Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06912087

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

Led by University of Chicago · Updated on 2025-12-02

36

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

E

Exelixis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck considered incurable by local therapies
  • Primary tumor located in oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, sinonasal, or unknown primary
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Measurable disease by RECIST 1.1 criteria
  • For oropharyngeal cancer, HPV (p16) testing required; p16 immunohistochemistry acceptable
  • For previously untreated recurrent/metastatic disease, PD-L1 combined positive score (CPS) of 1 or greater required; no PD-L1 restriction if prior anti-PD(L)1 therapy received
  • Recovery to baseline or Grade 1 or less from any prior adverse events, including immune-related events
  • Adequate organ and marrow function (ANC ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥9 g/dL, normal liver and kidney function)
  • Ability to understand and comply with study requirements and provide informed consent
  • Sexually active fertile subjects must agree to use highly effective contraception during the study and for 2 months after last cetuximab dose and 4 months after last pembrolizumab dose
Not Eligible

You will not qualify if you...

  • Prior treatment with Zanzalintinib or other VEGFR-targeted therapies, Cetuximab, or other EGFR inhibitors
  • More than two prior lines of systemic therapy in the recurrent/metastatic setting
  • Disease relapse within 3 months of definitive therapy
  • Recent treatment (2-4 weeks) with small molecule kinase inhibitors, chemotherapy, biologics, or other anticancer therapies before study start
  • Brain metastases or cranial epidural disease unless stable for at least 4 weeks after treatment
  • Use of oral anticoagulants or platelet inhibitors unless on stable acceptable doses
  • Active infection requiring systemic treatment or serious cardiovascular, gastrointestinal, or other health conditions affecting participation
  • Known or suspected autoimmune disease except type I diabetes or controlled skin disorders
  • Pregnant or breastfeeding women
  • Other malignancies within past 2 years except certain low-grade or localized skin cancers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

C

Clinical Trials Intake

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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