Intratumoral JNJ-90301900 combined with chemoradiation for locally advanced head and neck squamous cell carcinoma
A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
This phase 1b test will try injecting JNJ-90301900 directly into tumors alongside standard cisplatin chemotherapy and radiation to see if it is safe and helps people with locally advanced head and neck squamous cell carcinoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Johnson & Johnson Enterprise Innovation Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 16 sites (Birmingham, Alabama and 15 other locations) |
| Trial ID | NCT07219212 on ClinicalTrials.gov |
What this trial studies
This is an open-label, single-arm phase 1b trial giving intratumoral injections of JNJ-90301900 together with standard cisplatin-based chemotherapy and intensity-modulated radiation therapy (IMRT) to participants with locally advanced head and neck squamous cell carcinoma. The study enrolls patients with Stage III–IVB disease in specified primary sites who are candidates for definitive concurrent chemoradiation and have at least one measurable lesion. Primary goals are to characterize safety and tolerability and to obtain preliminary signals of anti-tumor activity using standard response criteria, with procedures conducted at multiple cancer centers. Participants will receive the investigational injections at the treating center alongside the planned chemoradiation schedule and will undergo regular follow-up for adverse events and tumor response.
Who should consider this trial
Good fit: Ideal candidates are adults with pathologically confirmed, locally advanced (Stage III–IVB) squamous cell carcinoma of the oral cavity, p16-negative oropharynx, hypopharynx, or supraglottic larynx who are fit for definitive cisplatin-based chemoradiation, have at least one measurable lesion, and an ECOG performance status of 0–1.
Not a fit: Patients with non-squamous histology, primary tumors of the nasopharynx/paranasal sinuses/salivary/thyroid/parathyroid/skin or unknown primary, early-stage or metastatic (stage 0–II or IVC) disease, loco-regionally recurrent or very recently synchronous second primaries, or those unable to receive cisplatin or with poor performance status are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could improve local tumor control and potentially increase cure rates while keeping systemic side effects manageable.
How similar studies have performed: Other early-phase trials combining intratumoral agents with radiation and chemotherapy have shown encouraging safety and local responses in small groups, but this specific JNJ-90301900 approach is novel and not yet proven in larger studies.
Eligibility criteria
Show full inclusion / exclusion 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 cisplatin chemotherapy * Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients
Where this trial is running
Birmingham, Alabama and 15 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- City of Hope — Duarte, California, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Moffit Cancer center — Tampa, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Hopital De La Cavale Blanche — Brest, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Hopital La Timone — Marseille, France (Recruiting)
- Centre Henri Becquerel — Rouen, France (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
- Hiroshima University Hospital — Hiroshima, Japan (Recruiting)
- Aichi Cancer Center — Nagoya, Japan (Recruiting)
- Tokyo Medical University Hospital — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.