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

Not Applicable

Not yet recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: JNJ-90301900; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy (IMRT)

• Registration Number: NCT07219212
• Lead Sponsor: Johnson & Johnson Enterprise Innovation Inc.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-17
• Study First Submitted QC: 2025-10-17
• Last Update Submitted: 2025-10-17
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-21
• Study Start: 2026-01-07
• Primary Completion: 2028-07-14
• Study Completion: 2028-07-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)	JNJ-90301900	Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of cisplatin and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)	Cisplatin	Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of cisplatin and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)	Intensity Modulated Radiation Therapy (IMRT)	Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of cisplatin and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) by Severity	Up to approximately 2 years 14 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) According to RECIST v.1.1	Up to approximately 2 years 14 weeks	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.
Complete Response (CR) Rate	Up to approximately 2 years 12 weeks	Percentage of participants achieving CR according to RECIST v.1.1 will be reported.
Disease Control Rate (DCR)	Up to approximately 2 years 12 weeks	DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v.1.1 criteria.
Injected Tumor Response Rate	Up to approximately 2 years 14 weeks	Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.
Time to Locoregional Failure (LRF)	Up to approximately 2 years 14 weeks	Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments.
Time to Distant Failure (DF)	Up to approximately 2 years 14 weeks	Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments.
Progression Free Survival (PFS)	Up to approximately 2 years 14 weeks	PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first.
Number of Participants with Post-Radiation Neck Dissection (PRND)	Up to approximately 2 years 14 weeks	Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.
Number of Participants with Post-Radiation Primary Salvage Surgery	Up to approximately 2 years 14 weeks	Participants with post-radiation primary salvage surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.