Status:
RECRUITING
A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Johnson & Johnson Enterprise Innovation Inc.
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
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 chemo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 14 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07219212
Start Date
December 11 2025
End Date
July 14 2028
Last Update
December 24 2025
Active Locations (2)
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1
City of Hope
Duarte, California, United States, 91010
2
Montefiore Medical Center
The Bronx, New York, United States, 10467