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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 74 Years
Eligible Sex
All
Accepts 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 cisplatin chemotherapy - Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: JNJ-90301900
    JNJ-90301900 will administered via intratumoral and/or intranodal injection.
    Other names:
    • NBTXR3
    • Functionalized hafnium oxide nanoparticles
  • Drug: Cisplatin
    Cisplatin will be administered intravenously.
  • Radiation: Intensity Modulated Radiation Therapy (IMRT)
    IMRT radiation therapy will be administered.

Recruiting Locations

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467

More Details

Status
Recruiting
Sponsor
Johnson & Johnson Enterprise Innovation Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.