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Clinical Trials in Japan / NCT07219212
Recruiting Phase 1

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

NCT07219212 · tracked via the Priya Life Science Japan tracker
Sponsor
Johnson & Johnson Enterprise Innovation Inc
Phase
Phase 1
Started
2026-01-26
Last updated
2026-09-25

Condition(s) studied

Squamous Cell Carcinoma of Head and Neck

Investigational drug(s) / intervention(s)

JNJ-90301900 →Cisplatin →Intensity Modulated Radiation Therapy (IMRT)Carboplatin →Paclitaxel →

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

Cisplatin: Cisplatin will be administered intravenously.

Intensity Modulated Radiation Therapy (IMRT): IMRT radiation therapy will be administered.

Carboplatin: Carboplatin will be administered intravenously.

Paclitaxel: Paclitaxel will be administered intravenously.

Study 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

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants with Adverse Events (AEs) by Severity — Up to approximately 2 years 14 weeks
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0.

Trial sites (20)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
City of Hope Duarte California Recruiting
University of California at San Diego Moores Cancer Center La Jolla California Suspended
Mayo Clinic Jacksonville Florida Recruiting
Moffit Cancer center Tampa Florida Recruiting
Emory University Atlanta Georgia Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Montefiore Medical Center The Bronx New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
University of Pennsylvania Philadelphia Pennsylvania 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

More Johnson & Johnson Enterprise Innovation Inc. trials in Japan

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC Recruiting

Other trials for the same condition

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer Recruiting
A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219212 on ClinicalTrials.gov ↗ ← All trials in Japan