A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT ID: NCT07219212
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-12-11
2028-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
JNJ-90301900
JNJ-90301900 will administered via intratumoral and/or intranodal injection.
Cisplatin
Cisplatin will be administered intravenously.
Intensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy will be administered.
Interventions
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JNJ-90301900
JNJ-90301900 will administered via intratumoral and/or intranodal injection.
Cisplatin
Cisplatin will be administered intravenously.
Intensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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Johnson & Johnson Enterprise Innovation Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Enterprise Innovation Inc.
Locations
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City of Hope
Duarte, California, United States
Montefiore Medical Center
The Bronx, New York, United States
Countries
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Central Contacts
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Other Identifiers
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90301900HNC1001
Identifier Type: OTHER
Identifier Source: secondary_id
2025-522914-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
90301900HNC1001
Identifier Type: -
Identifier Source: org_study_id