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 USA tracker

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Phase

Phase 1

Started

2026-01-26

Last updated

2026-08-28

Condition(s) studied

Squamous Cell Carcinoma of Head and Neck

Investigational drug(s) / intervention(s)

JNJ-90301900CisplatinIntensity Modulated Radiation Therapy (IMRT)CarboplatinPaclitaxel

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

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 (19)

Facility	City	Region	Status
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	Recruiting
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
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 the USA

A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors Recruiting

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC) Recruiting

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

A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer Active, not recruiting

A Study of JNJ-1761981 in Participants With Solid Tumors Recruiting

Other trials for the same condition

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

A Study of DM005 in Patients With Advanced Solid Tumors Recruiting

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer Active, not recruiting

A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors Active, not recruiting

A Phase 1b Study of WU-NK-101 in Combination With Cetuximab Active, not 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 the USA