NCT07219212From ClinicalTrials.govRecruiting

A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Enrolment target: 45
Started: 26 January 2026
Main results due: 14 July 2028
Study sites: 20
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 74 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion criteria:

* Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
* Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines
* A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines
* Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Exclusion criteria:

* Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site
* Non-squamous histology
* Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)
* Ineligible to receive platinum-based chemotherapy
* Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients

What this study is about

In the sponsor’s own words, from the registry.

This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).

Study sites(20)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
City of Hope
Duarte, California, United States
Recruiting
University of California at San Diego Moores Cancer Center
La Jolla, California, United States
Suspended
Mayo Clinic
Jacksonville, Florida, United States
Recruiting
Moffit Cancer center
Tampa, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
Hopital De La Cavale Blanche
Brest, France
Recruiting
CHU de Grenoble
La Tronche, France
Recruiting
Centre Oscar Lambret
Lille, France
Recruiting
Hopital La Timone
Marseille, France
Recruiting
Centre Henri Becquerel
Rouen, France
Recruiting
Gustave Roussy
Villejuif, France
Recruiting
Hiroshima University Hospital
Hiroshima, Japan
Recruiting
Aichi Cancer Center
Nagoya, Japan
Recruiting
Shizuoka Cancer Center
Shizuoka, Japan
Recruiting
Tokyo Medical University Hospital
Tokyo, Japan
Recruiting

Showing 20 of 20 sites. 19 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07219212. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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