Clinical Trial Details
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Phase IInterventional
A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Protocol: 2025P011992NCT: NCT07219212
Overview
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
| Ages | 18 Years - 74 Years |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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
Investigators
Locations
Emory University Hospital Midtown
Emory Proton Therapy Center