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New treatment option for Head and Neck Neoplasms
Official title Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
ClinicalTrials.gov ID: NCT06912087
What this study is testing
What is Zanzalintinib?
Zanzalintinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for head and neck neoplasms.
Also referred to as XL 092, XL-092.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), which is considered...
- 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.
You likely can't join if
- Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal...
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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 people 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...
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.