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NCT06912087
Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
Phase 1 trial testing Zanzalintinib in Head and Neck Neoplasms in 36 participants. Currently enrolling.
5 June 2027
Quick facts
| Lead sponsor | University of Chicago |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 29 September 2025 |
| Primary completion | 5 June 2027 |
| Estimated completion | 5 June 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Zanzalintinib — full drug profile →
- Cetuximab (cetuximab) — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →
- Carcinoma, Squamous Cell — all drugs for Carcinoma, Squamous Cell →
- Neoplasm Recurrence, Local — all drugs for Neoplasm Recurrence, Local →
- Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
Sponsor
University of Chicago
Who can join
18 and older, any sex, with Head and Neck Neoplasms or Carcinoma, Squamous Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06912087
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07283731 — Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma · Phase 2 · recruiting
- NCT07489495 — A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-0 · Phase 3 · not yet recruiting
- NCT07511504 — Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanc · Phase 2 · not yet recruiting
Other recruiting trials for Head and Neck Neoplasms
Currently open trials in the same condition.
- NCT07491536 — Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis · NA · recruiting
- NCT07158164 — DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment · Phase 4 · recruiting
- NCT06998069 — Head and Neck Cancer Study Project in the Geriatric Population · Phase 3 · recruiting
- NCT06303180 — NIDCD Otolaryngology Clinical Protocol Biospecimen Bank · recruiting
- NCT06291610 — Feasibility Testing a Decision-support Intervention for Clinical Trials · NA · recruiting
Other University of Chicago trials
Trials by the same sponsor.
- NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck · Phase 2 · not yet recruiting
- NCT07354100 — Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy · Phase 1, PHASE2 · not yet recruiting
- NCT06446661 — Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia · NA · not yet recruiting
- NCT07179315 — A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Tr · Phase 2 · not yet recruiting
- NCT07126561 — Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06912087 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Chicago
- Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06912087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing