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Recruiting
NCT07219212
A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions: Squamous Cell Carcinoma of Head and Neck
Sex: All
Ages: 18 Years – 74 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 45
Sponsor: Johnson & Johnson Enterprise Innovation Inc.
Location: University of Alabama at Birmingham Birmingham Alabama
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 Criteria
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
Source: ClinicalTrials.gov (NCT07219212). StuddyBuddy aggregates publicly available trial information.