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NCT06912087 · ClinicalTrials.gov registry record · Phase 1
Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
A Phase 1 study of Neoplasm Metastasis and Head and Neck Neoplasms, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06912087: Recruiting Phase 1 study of Neoplasm Metastasis and Head and Neck Neoplasms, sponsored by University of Chicago.
NCT06912087 is a Phase 1 study of Neoplasm Metastasis and Head and Neck Neoplasms that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 36 participants, below the 415-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06912087, a Phase 1 study of Neoplasm Metastasis and Head and Neck Neoplasms, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
The MTD will be defined as the dose combination with a dose-limiting toxicities (DLT) rate closest to the target DLT rate of 25%.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Zanzalintinib
- DRUG Cetuximab
Study Locations (1)
Illinois
- University of Chicago Medicine Comprehensive Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-09-29 |
| Est. Completion | 2027-06-05 |
| Phase | Phase 1 |
What NCT06912087 shows while recruiting
NCT06912087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 415-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (91% lower).
The record links to 6 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06912087 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06912087 about?
NCT06912087 is a clinical study titled "Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC". 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 tolerat...
What is the current status of trial NCT06912087?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-09-29. Estimated completion is 2027-06-05.
What conditions does trial NCT06912087 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Metastatic Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06912087?
The interventions under investigation include: Pembrolizumab (DRUG), Zanzalintinib (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT06912087?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06912087 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06912087's enrollment target sits among peer trials
36 34th of 41 higher than 7 of 41 other Neoplasm Metastasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasm Metastasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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