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

Study Identifier:
90301900HNC1001
CT.gov Identifier:
NCT07219212
EudraCT Identifier:
202552291422
EU Trial (CTIS) Number:
2025-522914-22-00
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Head & Neck
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18 - 74 Years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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 - 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 - 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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Ester Garcia Lorenzo
Status
Will Be Recruiting
Condition(s) Treated at Site
Head & Neck