JNJ-90301900 with Chemoradiation for Head and Neck Cancer

This study is looking at a treatment called JNJ-90301900, which is injected directly into tumors, alongside standard chemotherapy (Cisplatin, Carboplatin, Paclitaxel) and radiation therapy (IMRT). It's for people with locally advanced head and neck squamous cell carcinoma (HNSCC), a type of cancer that starts in the mouth or throat. The main goal is to see how safe JNJ-90301900 is and what side effects it might cause. The study plans to enroll about 45 participants between 18 and 74 years old who have Stage III, IVA, or IVB HNSCC and are able to receive standard chemoradiation. The study's current status is unclear.

Study design
This is a Phase 1b, global, open-label, single-arm study, meaning all 45 participants will receive the same treatments, and everyone involved will know what treatments are being given.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 2 years and 14 weeks.

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NCT07219212

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

Recruiting
PHASE1Ages 18–74InterventionalTreatment
Johnson & Johnson Enterprise Innovation Inc.
~45 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:JNJ-90301900CisplatinIntensity Modulated Radiation Therapy (IMRT)CarboplatinPaclitaxel

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AEs) by Severity
Measured over Up to approximately 2 years 14 weeks
Squamous Cell Carcinoma of Head and Neck
19 sites across 10 states
France5
Japan4
California2
Florida2
Alabama1
Georgia1
Massachusetts1
New York1
  • Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial · STUDY_DIRECTOR · Johnson & Johnson Enterprise Innovation Inc.

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Eligibility criteria

Inclusion

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

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
  • Number of Participants with Adverse Events (AEs) by SeverityUp 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.