A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

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A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Status
Active
Cancer Type
Head and Neck Cancer
Trial Phase
Phase I
Eligibility
18 - 74 Years, Male and Female
Study Type
Treatment
NCT ID
NCT07219212
Protocol IDs
90301900HNC1001 (primary)
NCI-2025-09717
2025
2025-522914-22-00
90301900HNC1001
Study Sponsor
Johnson & Johnson Enterprise Innovation Inc.

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

  1. Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
  2. Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines
  3. A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines
  4. Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Treatment Sites in Georgia

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

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