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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.

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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%.

Interventions

  • DRUG Pembrolizumab
  • DRUG Zanzalintinib
  • DRUG Cetuximab

Study Locations (1)

Illinois

  • University of Chicago Medicine Comprehensive Cancer Center - Chicago

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-09-29
Est. Completion 2027-06-05
Phase Phase 1
University of Chicago

796 total trials

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.

Similar trials for Neoplasm Metastasis

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 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT06912087, the US trial registry maintained by the National Library of Medicine. NCT06912087 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.