New injection plus chemo-radiation targets tough head and neck tumors
NCT ID NCT07219212
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This early-stage study is testing whether a new drug, JNJ-90301900, is safe and works when injected directly into tumors along with standard chemotherapy and radiation. It involves 30 adults with advanced head and neck cancer. The main goal is to check for side effects and see how well the combination shrinks tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
19 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aichi Cancer Center
RECRUITINGNagoya, 464-8681, Japan
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Boston Medical Center
RECRUITINGBoston, Massachusetts, 02118, United States
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Centre Henri Becquerel
RECRUITINGRouen, 76038, France
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Centre Oscar Lambret
RECRUITINGLille, 59000, France
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City of Hope
RECRUITINGDuarte, California, 91010, United States
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Emory University
RECRUITINGAtlanta, Georgia, 30308, United States
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Gustave Roussy
RECRUITINGVillejuif, 94805, France
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Hiroshima University Hospital
RECRUITINGHiroshima, 734 8551, Japan
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Hopital De La Cavale Blanche
RECRUITINGBrest, 29200, France
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Hopital La Timone
RECRUITINGMarseille, 13385, France
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
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Moffit Cancer center
RECRUITINGTampa, Florida, 33612, United States
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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Shizuoka Cancer Center
RECRUITINGShizuoka, 411 8777, Japan
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Tokyo Medical University Hospital
RECRUITINGTokyo, 160-0023, Japan
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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University of California at San Diego Moores Cancer Center
RECRUITINGLa Jolla, California, 92093, United States
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University of North Carolina at Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27514, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Shorter radiation course tested for advanced head and neck cancer
- Can an experimental drug shrink advanced solid tumors?
- Smartphone app aims to combat malnutrition in head and neck cancer patients
- Can adding radiation boost immunotherapy against spread head and neck cancer?
- Can a Two-Pronged attack shrink Hard-to-Treat cancers?
- New hope for hard-to-treat cancers? experimental combo enters phase 2 trial