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NCT07219212PHASE1Recruiting

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

Johnson & Johnson Enterprise Innovation Inc.

Start Date

1/26/2026

Completion Date

7/14/2028

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 Criteria

Age Range: 18 years to 74 years

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

Interventions

DRUG

JNJ-90301900

DRUG

Cisplatin

RADIATION

Intensity Modulated Radiation Therapy (IMRT)

DRUG

Carboplatin

DRUG

Paclitaxel

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Conditions

Squamous Cell Carcinoma of Head and Neck

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

City of Hope

Duarte, California 91010

United States

University of California at San Diego Moores Cancer Center

La Jolla, California 92093

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Moffit Cancer center

Tampa, Florida 33612

United States

Emory University

Atlanta, Georgia 30308

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Hopital De La Cavale Blanche

Brest, 29200

France

Centre Oscar Lambret

Lille, 59000

France

Hopital La Timone

Marseille, 13385

France

Centre Henri Becquerel

Rouen, 76038

France

Gustave Roussy

Villejuif, 94805

France

Hiroshima University Hospital

Hiroshima, 734 8551

Japan

Aichi Cancer Center

Nagoya, 464-8681

Japan

Shizuoka Cancer Center

Shizuoka, 411 8777

Japan

Tokyo Medical University Hospital

Tokyo, 160-0023

Japan