Head and Neck NeoplasmsPhase 1NCT06912087
Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
A Phase 1 study testing Zanzalintinib, Cetuximab and Pembrolizumab in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by University of Chicago at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Neoplasm Recurrence, Local
- What is being tested?
- Zanzalintinib, Cetuximab and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 5 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), which is considered incurable by local therapies.
- Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible.
- Age: Participants must be at least 18 years old.
- ECOG Performance Status: Must be 0-1.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing.
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- Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R/M disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy.
- Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from any adverse events (AEs), including immune-related AEs from prior treatments.
- Adequate organ and marrow function, including:
- Absolute neutrophil count (ANC) ≥ 1500/mm3.
- Platelets ≥ 100,000/mm3.
- Hemoglobin ≥ 9 g/dL.
- Normal liver and kidney function.
- Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
- Contraception: Sexually active fertile subjects must agree to use a highly effective method of contraception during the study and for 2 months after the last dose of cetuximab and 4 months after the last dose of pembrolizumab.
Who cannot join
- Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors.
- More than two prior lines of systemic therapy in the recurrent/metastatic setting.
- Relapsed disease within 3 months of definitive therapy.
- Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment).
- Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks.
- Concomitant anticoagulation with oral anticoagulants or platelet inhibitors, unless on stable doses of acceptable anticoagulants.
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- Active infection requiring systemic treatment or significant cardiovascular, gastrointestinal, or other serious health issues that may affect study participation.
- Known or suspected autoimmune disease, except for specific conditions like type I diabetes or controlled skin disorders.
- Pregnancy or breastfeeding: Women must not be pregnant or breastfeeding at screening.
- Other malignancies within the past 2 years (except for certain low-grade cancers like localized skin cancers).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Cancer Trial Intake, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ari Rosenberg, MD
About this study
Official title: A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
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).
Read the detailed description
This Phase I, single-site clinical trial investigates the combination therapy of Zanzalintinib, an oral tyrosine kinase inhibitor, with Pembrolizumab, an anti-PD1 immune checkpoint inhibitor, and Cetuximab, an anti-EGFR monoclonal antibody, in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The primary objective is to determine the maximally tolerated dose (MTD) and the recommended Phase II dose (RP2D) of Zanzalintinib in combination with Pembrolizumab and Cetuximab.
Secondary objectives include evaluating safety, tolerability, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will investigate the effects of the treatment on plasma circulating tumor DNA (ctDNA) levels, immune phenotype, genetic alterations, and histopathologic changes in tumor biopsies.
The trial uses a dose-escalation design, with a 42-day treatment cycle, to assess safety and dose-limiting toxicities. This combination targets the immune-suppressive tumor microenvironment, aiming to overcome resistance mechanisms and improve clinical outcomes for a population with limited therapeutic options.
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Neoplasm Recurrence, Local, Neoplasm Metastasis, Recurrent Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma
- Being tested
- Zanzalintinib, Cetuximab, Pembrolizumab
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Neoplasm Recurrence, Local, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanzalintinibDrug
Also called XL 092, XL-092, XL092
Experimental receptor tyrosine kinases (RTKs)
CetuximabDrug
Also called Erbitux
Food and Drug Administration (FDA) approved monoclonal antibody directed against the epidermal growth factor (EGFR).
PembrolizumabDrug
Also called Keytruda
FDA approved monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Dose Level -1) | Experimental | Participants receive the combination of the following drugs in 42-day cycles:
* Zanzalintinib at a dose of 20 mg daily on days 1-42 of each cycle
* Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle
* Pembrolizumab 400 mg on day 1 of each cycle Receives: Drug: Zanzalintinib; Drug: Cetuximab; Drug: Pembrolizumab |
| Dose Escalation (Dose Level 0) | Experimental | Participants receive the combination of the following drugs in 42-day cycles:
* Zanzalintinib at a dose of 40 mg daily on days 1-42 of each cycle
* Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle
* Pembrolizumab 400 mg on day 1 of each cycle
This will be the first dose escalation enrolled. Dose Levels 1 and/or -1 will be enrolled depending on side effects seen in participants enrolled to this cohort. Receives: Drug: Zanzalintinib; Drug: Cetuximab; Drug: Pembrolizumab |
| Dose Escalation (Dose Level 1) | Experimental | Participants receive the combination of the following drugs in 42-day cycles:
* Zanzalintinib at a dose of 60 mg daily on days 1-42 of each cycle
* Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle
* Pembrolizumab 400 mg on day 1 of each cycle Receives: Drug: Zanzalintinib; Drug: Cetuximab; Drug: Pembrolizumab |
| Dose Expansion | Experimental | Participants receive the combination of the following drugs in 42-day cycles:
* Zanzalintinib will be dosed daily (days 1-42) at the dose identified as recommended phase 2 dose during dose escalation.
* Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle
* Pembrolizumab 400 mg on day 1 of each cycle
The expansion cohort will begin enrollment after the dose escalation cohorts have completed enrollment. Receives: Drug: Zanzalintinib; Drug: Cetuximab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally Tolerated Dose (MTD) of Zanzalintinib in Combination with Pembrolizumab and Cetuximab
The MTD will be defined as the dose combination with a dose-limiting toxicities (DLT) rate closest to the target DLT rate of 25%.
Measured: end of DLT evaluation period (first 28 days of treatment)
Recommended Phase II Dose (RP2D) of Zanzalintinib in Combination with Pembrolizumab and Cetuximab
The RP2D will be defined as the MTD identified after enrollment to all cohorts.
Measured: End of enrollment
Secondary outcomes (3)
Progression-Free Survival (PFS)
The secondary outcome measure of Progression-Free Survival (PFS) will assess the time from the first dose of the study drug (Zanzalintinib, Pembrolizumab, and Cetuximab) to the date of documented disease progression (PD) based on RECIST v1.1 or death, whichever occurs first. This measure will help evaluate the efficacy of the combination therapy in delaying disease progression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Measured: 2 years from the date of the final subject accrual on study
Overall Survival (OS)
The secondary outcome measure of Overall Survival (OS) will evaluate the time from the first dose of the study drug (Zanzalintinib, Pembrolizumab, and Cetuximab) to the date of death from any cause. This outcome will help assess the overall impact of the combination therapy on patient survival in recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Measured: 2 years from the date of the final subject accrual on study
Safety of zanzalintinib in combination with pembrolizumab and cetuximab
Adverse events (AEs) leading to discontinuation or death, and severity of AEs will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: End of treatment (about 24 months on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start29 Sep 2025
- Primary completion5 Jun 2027 (estimated)
- Study completion5 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Exelixis
- Responsible party
- Sponsor
- Investigators
- Ari Rosenberg, MD, Principal investigator, University of Chicago Medicine Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912087
- Sponsor's protocol ID
- IRB24-1994
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The document you provided does not include a specific IPD (Individual Patient Data) Sharing Plan or details regarding what patient data may be shared with other researchers. Typically, this information is outlined in separate documentation, such as consent forms or data sharing agreements, and would depend on institutional policies or specific regulatory requirements. If you require more detailed information about the plan to share IPD for this study, I recommend contacting the Principal Investigator or the University of Chicago Medicine Comprehensive Cancer Center directly to inquire about their data sharing practices.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT06912087
- Acronym / sponsor ID
- IRB24-1994
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Neoplasm Recurrence, Local, Neoplasm Metastasis, Recurrent Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Exelixis
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 5 Jun 2027 (estimated)
- Study completion
- 5 Jun 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This Phase I, single-site clinical trial investigates the combination therapy of Zanzalintinib, an oral tyrosine kinase inhibitor, with Pembrolizumab, an anti-PD1 immune checkpoint inhibitor, and Cetuximab, an anti-EGFR monoclonal antibody, in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The primary objective is to determine the maximally tolerated dose (MTD) and the recommended Phase II dose (RP2D) of Zanzalintinib in combination with Pembrolizumab and Cetuximab.
Secondary objectives include evaluating safety, tolerability, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will investigate the effects of the treatment on plasma circulating tumor DNA (ctDNA) levels, immune phenotype, genetic alterations, and histopathologic changes in tumor biopsies.
The trial uses a dose-escalation design, with a 42-day treatment cycle, to assess safety and dose-limiting toxicities. This combination targets the immune-suppressive tumor microenvironment, aiming to overcome resistance mechanisms and improve clinical outcomes for a population with limited therapeutic options.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Dose Level -1) | Experimental | Drug: Zanzalintinib, Drug: Cetuximab, Drug: PembrolizumabParticipants receive the combination of the following drugs in 42-day cycles: * Zanzalintinib at a dose of 20 mg daily on days 1-42 of each cycle * Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle * Pembrolizumab 400 mg on day 1 of each cycle |
| Dose Escalation (Dose Level 0) | Experimental | Drug: Zanzalintinib, Drug: Cetuximab, Drug: PembrolizumabParticipants receive the combination of the following drugs in 42-day cycles: * Zanzalintinib at a dose of 40 mg daily on days 1-42 of each cycle * Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle * Pembrolizumab 400 mg on day 1 of each cycle This will be the first dose escalation enrolled. Dose Levels 1 and/or -1 will be enrolled depending on side effects seen in participants enrolled to this cohort. |
| Dose Escalation (Dose Level 1) | Experimental | Drug: Zanzalintinib, Drug: Cetuximab, Drug: PembrolizumabParticipants receive the combination of the following drugs in 42-day cycles: * Zanzalintinib at a dose of 60 mg daily on days 1-42 of each cycle * Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle * Pembrolizumab 400 mg on day 1 of each cycle |
| Dose Expansion | Experimental | Drug: Zanzalintinib, Drug: Cetuximab, Drug: PembrolizumabParticipants receive the combination of the following drugs in 42-day cycles: * Zanzalintinib will be dosed daily (days 1-42) at the dose identified as recommended phase 2 dose during dose escalation. * Cetuximab at a dose of 500 mg/m2 on days 1, 15, and 29 of each cycle * Pembrolizumab 400 mg on day 1 of each cycle The expansion cohort will begin enrollment after the dose escalation cohorts have completed enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), which is considered incurable by local therapies.
- Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible.
- Age: Participants must be at least 18 years old.
- ECOG Performance Status: Must be 0-1.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Key exclusion criteria (10 listed)
- Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors.
- More than two prior lines of systemic therapy in the recurrent/metastatic setting.
- Relapsed disease within 3 months of definitive therapy.
- Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment).
- Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanzalintinibAlso: XL 092, XL-092, XL092Experimental receptor tyrosine kinases (RTKs) | Drug | Dose Escalation (Dose Level -1), Dose Escalation (Dose Level 0), Dose Escalation (Dose Level 1), Dose Expansion |
| CetuximabAlso: ErbituxFood and Drug Administration (FDA) approved monoclonal antibody directed against the epidermal growth factor (EGFR). | Drug | Dose Escalation (Dose Level -1), Dose Escalation (Dose Level 0), Dose Escalation (Dose Level 1), Dose Expansion |
| PembrolizumabAlso: KeytrudaFDA approved monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) | Drug | Dose Escalation (Dose Level -1), Dose Escalation (Dose Level 0), Dose Escalation (Dose Level 1), Dose Expansion |
Primary outcome
Maximally Tolerated Dose (MTD) of Zanzalintinib in Combination with Pembrolizumab and Cetuximab
Time frame: end of DLT evaluation period (first 28 days of treatment)
The MTD will be defined as the dose combination with a dose-limiting toxicities (DLT) rate closest to the target DLT rate of 25%.
Recommended Phase II Dose (RP2D) of Zanzalintinib in Combination with Pembrolizumab and Cetuximab
Time frame: End of enrollment
The RP2D will be defined as the MTD identified after enrollment to all cohorts.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years from the date of the final subject accrual on study
Overall Survival (OS)
Time frame: 2 years from the date of the final subject accrual on study
Safety of zanzalintinib in combination with pembrolizumab and cetuximab
Time frame: End of treatment (about 24 months on average)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. The document you provided does not include a specific IPD (Individual Patient Data) Sharing Plan or details regarding what patient data may be shared with other researchers. Typically, this information is outlined in separate documentation, such as consent forms or data sharing agreements, and would depend on institutional policies or specific regulatory requirements. If you require more detailed information about the plan to share IPD for this study, I recommend contacting the Principal Investigator or the University of Chicago Medicine Comprehensive Cancer Center directly to inquire about their data sharing practices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ari Rosenberg, MD principal investigator
University of Chicago Medicine Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zanzalintinib, Cetuximab and Pembrolizumab in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximally Tolerated Dose (MTD) of Zanzalintinib in Combination with Pembrolizumab and Cetuximab (time frame: end of DLT evaluation period (first 28 days of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.