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

Recruiting now · Phase 1

Conditions studied: Squamous Cell Carcinoma of Head and Neck

In brief

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).

Key facts

Study ID

NCT07219212

Run by

Johnson & Johnson Enterprise Innovation Inc.

People needed

45

Starts

2026-01-26

Expected to finish

2028-07-14

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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