RecruitingPhase 1NCT07219212

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


Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Enrollment

30 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called JNJ-90301900 combined with the standard treatment of chemotherapy plus radiation for people with locally advanced head and neck squamous cell carcinoma (HNSCC) — a type of cancer in the mouth, throat, or voicebox that has spread to nearby tissue or lymph nodes but not yet to distant organs. **You may be eligible if...** - You have confirmed squamous cell carcinoma of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx - Your cancer is Stage III, IVA, or IVB - You are a candidate for standard chemoradiation treatment (chemotherapy combined with radiation) - You have at least one measurable tumor - You are generally well enough for treatment (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer originated in the nasopharynx, sinuses, salivary glands, thyroid, skin, or is of unknown primary site - Your cancer is at Stage 0, I, II, or has spread to distant organs (Stage IVC) - Your cancer has come back (recurrent) or you have a second simultaneous head and neck cancer - You cannot safely receive cisplatin chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-90301900

JNJ-90301900 will administered via intratumoral and/or intranodal injection.

DRUGCisplatin

Cisplatin will be administered intravenously.

RADIATIONIntensity Modulated Radiation Therapy (IMRT)

IMRT radiation therapy will be administered.


Locations(12)

City of Hope

Duarte, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Moffit Cancer center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Montefiore Medical Center

The Bronx, New York, United States

Hopital De La Cavale Blanche

Brest, France

Centre Oscar Lambret

Lille, France

Hopital La Timone

Marseille, France

Centre Henri Becquerel

Rouen, France

Gustave Roussy

Villejuif, France

Aichi Cancer Center

Nagoya, Japan

Tokyo Medical University Hospital

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07219212


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