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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Johnson & Johnson Enterprise Innovation Inc. • ClinicalTrials.gov ID: NCT07219212

Registry updated: 2026-09-25
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Description

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).

Interventions

  • JNJ-90301900 (Drug)
    JNJ-90301900 will administered via intratumoral and/or intranodal injection.
  • Cisplatin (Drug)
    Cisplatin will be administered intravenously.
  • Intensity Modulated Radiation Therapy (IMRT) (Radiation)
    IMRT radiation therapy will be administered.
  • Carboplatin (Drug)
    Carboplatin will be administered intravenously.
  • Paclitaxel (Drug)
    Paclitaxel will be administered intravenously.

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

Conditions

Squamous Cell Carcinoma of Head and Neck

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record