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).
Brief Title
A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
844-434-4210
Central Contact Email
Participate-In-This-Study1@its.jnj.com
Completion Date
Completion Date Type
Estimated
Conditions
Squamous Cell Carcinoma of Head and Neck
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
74 Years
Minimum Age
18 Years
NCT Id
NCT07219212
Org Class
Industry
Org Full Name
Johnson & Johnson Enterprise Innovation Inc.
Org Study Id
90301900HNC1001
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Primary Outcomes
Outcome Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0.
Outcome Measure
Number of Participants with Adverse Events (AEs) by Severity
Outcome Time Frame
Up to approximately 2 years 14 weeks
Secondary Ids
Secondary Id
90301900HNC1001
Secondary Id
2025-522914-22-00
Secondary Outcomes
Outcome Description
ORR defined as percentage of participants achieving complete response (CR) or partial response (PR) by investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
Outcome Time Frame
Up to approximately 2 years 14 weeks
Outcome Measure
Objective Response Rate (ORR) According to RECIST v.1.1
Outcome Description
Percentage of participants achieving CR according to RECIST v.1.1 will be reported.
Outcome Time Frame
Up to approximately 2 years 12 weeks
Outcome Measure
Complete Response (CR) Rate
Outcome Description
DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v.1.1 criteria.
Outcome Time Frame
Up to approximately 2 years 12 weeks
Outcome Measure
Disease Control Rate (DCR)
Outcome Description
Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.
Outcome Time Frame
Up to approximately 2 years 14 weeks
Outcome Measure
Injected Tumor Response Rate
Outcome Description
Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments.
Outcome Time Frame
Up to approximately 2 years 14 weeks
Outcome Measure
Time to Locoregional Failure (LRF)
Outcome Description
Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments.
Outcome Time Frame
Up to approximately 2 years 14 weeks
Outcome Measure
Time to Distant Failure (DF)
Outcome Description
PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first.
Outcome Time Frame
Up to approximately 2 years 14 weeks
Outcome Measure
Progression Free Survival (PFS)
Outcome Description
Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.
Outcome Time Frame
Up to approximately 2 years 14 weeks
Outcome Measure
Number of Participants with Post-Radiation Neck Dissection (PRND)
Outcome Description
Participants with post-radiation primary salvage surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.
Outcome Time Frame
Up to approximately 2 years 14 weeks
Outcome Measure
Number of Participants with Post-Radiation Primary Salvage Surgery
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
74
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rafi Kabarriti
Investigator Email
RKABARRI@MONTEFIORE.ORG
Investigator Department
Radiation Oncology
Investigator Sponsor Organization
External
Study Department
Radiation Oncology
Study Division
Radiation Oncology
Categories Mesh Debug
Cancer --- CARCINOMA
Cancer --- NEOPLASMS
Cancer --- NEOPLASMS BY SITE
MeSH Terms
SQUAMOUS CELL CARCINOMA OF HEAD AND NECK
CARCINOMA, SQUAMOUS CELL
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEAD AND NECK NEOPLASMS
NEOPLASMS BY SITE
CISPLATIN
RADIOTHERAPY, INTENSITY-MODULATED
CHLORINE COMPOUNDS
INORGANIC CHEMICALS
NITROGEN COMPOUNDS
PLATINUM COMPOUNDS
RADIOTHERAPY, CONFORMAL
RADIOTHERAPY, COMPUTER-ASSISTED
RADIOTHERAPY
THERAPEUTICS