Recruiting
Phase 1

JNJ-90301900 with Chemotherapy

Sponsor:

Johnson & Johnson Enterprise Innovation Inc.

Code:

NCT07219212

Conditions

Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

JNJ-90301900

Cisplatin

Intensity Modulated Radiation Therapy (IMRT)

Carboplatin

Paclitaxel

Study Details

Brief 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).

Conditions

Squamous Cell Carcinoma of Head and Neck

Study ID

NCT07219212

Start date

Jan 26, 2026

Status verified date

Sep, 2026

Completion date

Jul 14, 2028

Anticipated

Primary completion date

Jul 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)

Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.

Interventions

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.

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to approximately 2 years 14 weeks ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

City of Hope

Recruiting

Duarte, California, United States, 91010

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Moffit Cancer center

Recruiting

Tampa, Florida, United States, 33612

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Johnson & Johnson Enterprise Innovation Inc. on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.