drugset / Trial / NCT06912087
Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2025-09-29
- Primary completion
- 2027-06-05
- Completion
- 2027-06-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zanzalintinib | Small molecule | 20 mg | Oral |
| Subject | Zanzalintinib | Small molecule | 40 mg | Oral |
| Subject | Zanzalintinib | Small molecule | 60 mg | Oral |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | — |
| Background | Pembrolizumab | Monoclonal antibody | 400 mg | — |