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NCT06919666 · ClinicalTrials.gov registry record · Phase 1
NT219 Combined With Standard of Care Biologic Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT06919666: Recruiting Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Colorado, Denver.
NCT06919666 is a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 29 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06919666, a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
Fixed dose NT219 weekly plus pembrolizumab every 3 weeks or cetuximab weekly to be continued until progression, unacceptable toxicity, or investigator or participant decision.
Primary Outcome
Objective response rate is defined as the percentage of participants who have confirmed best response of complete response or partial response as determined by the investigator. Response will be assessed by RECIST 1.1 or iRECIST (when applicable, cohort 1 only) at baseline (within 28 days of C1D1) and every 9 weeks +/- 10 days while on treatment. All scans during study intervention will be repeated using the same method (CT, PET-CT, or MRI).
Conditions Studied
Interventions
- DRUG NT219
Study Locations (2)
Colorado
- Universtiy of Colorado Hospital - Aurora
- UCHealth Highlands Ranch Hospital - Highlands Ranch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2025-06-12 |
| Est. Completion | 2031-02 |
| Phase | Phase 1 |
What NCT06919666 shows while recruiting
NCT06919666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which NT219 is the first listed.
NCT06919666 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06919666 about?
NCT06919666 is a clinical study titled "NT219 Combined With Standard of Care Biologic Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma". Fixed dose NT219 weekly plus pembrolizumab every 3 weeks or cetuximab weekly to be continued until progression, unacceptable toxicity, or investigator or participant decision.
What is the current status of trial NCT06919666?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2025-06-12. Estimated completion is 2031-02.
What conditions does trial NCT06919666 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06919666?
The interventions under investigation include: NT219 (DRUG).
Who is sponsoring clinical trial NCT06919666?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06919666 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06919666's enrollment target sits among peer trials
29 186th of 250 higher than 64 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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