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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Study ID
NCT07219212
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Jan 26, 2026
Status verified
Jun 2026
Primary completion
Jul 14, 2028
Completion
Jul 14, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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 cisplatin 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.

Primary Outcome Measure

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

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
City of HopeDuarteCalifornia91010-
Mayo ClinicJacksonvilleFlorida32224-
Moffit Cancer centerTampaFlorida33612-
Emory UniversityAtlantaGeorgia30308-
Boston Medical CenterBostonMassachusetts02118-
Montefiore Medical CenterThe BronxNew York10467-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CAMayo Clinic· Jacksonville, FLMoffit Cancer center· Tampa, FLEmory University· Atlanta, GABoston Medical Center· Boston, MA

Related Studies