NCT07219212 A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT07219212 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johnson & Johnson Enterprise Innovation Inc. |
| Condition | Squamous Cell Carcinoma of Head and Neck |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2028-07-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-01-26 with a primary completion date of 2028-07-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial
STUDY DIRECTOR
Johnson & Johnson Enterprise Innovation Inc.
Frequently Asked Questions
Who can join the NCT07219212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Squamous Cell Carcinoma of Head and Neck. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07219212 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07219212 currently recruiting?
Yes, NCT07219212 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07219212 trial being conducted?
This trial is being conducted at Birmingham, United States, Duarte, United States, Jacksonville, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT07219212 clinical trial?
NCT07219212 is sponsored by Johnson & Johnson Enterprise Innovation Inc.. The principal investigator is Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial at Johnson & Johnson Enterprise Innovation Inc.. The trial plans to enroll 30 participants.