NCT07219212

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
26mo left

Started Jan 2026

Typical duration for phase_1

Geographic Reach
3 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

October 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 26, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2028

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2.5 years

First QC Date

October 17, 2025

Last Update Submit

May 7, 2026

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events (AEs) by Severity

    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.

    Up to approximately 2 years 14 weeks

Secondary Outcomes (9)

  • Objective Response Rate (ORR) According to RECIST v.1.1

    Up to approximately 2 years 14 weeks

  • Complete Response (CR) Rate

    Up to approximately 2 years 12 weeks

  • Disease Control Rate (DCR)

    Up to approximately 2 years 12 weeks

  • Injected Tumor Response Rate

    Up to approximately 2 years 14 weeks

  • Time to Locoregional Failure (LRF)

    Up to approximately 2 years 14 weeks

  • +4 more secondary outcomes

Study Arms (1)

JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)

EXPERIMENTAL

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.

Drug: JNJ-90301900Drug: CisplatinRadiation: Intensity Modulated Radiation Therapy (IMRT)

Interventions

JNJ-90301900DRUG

JNJ-90301900 will administered via intratumoral and/or intranodal injection.

Also known as: NBTXR3, Functionalized hafnium oxide nanoparticles
JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)
CisplatinDRUG

Cisplatin will be administered intravenously.

JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)
Intensity Modulated Radiation Therapy (IMRT)RADIATION

IMRT radiation therapy will be administered.

JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Moffit Cancer center

Tampa, Florida, 33612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Hopital De La Cavale Blanche

Brest, 29200, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

Hopital La Timone

Marseille, 13385, France

RECRUITING

Centre Henri Becquerel

Rouen, 76038, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Hiroshima University Hospital

Hiroshima, 734 8551, Japan

RECRUITING

Aichi Cancer Center

Nagoya, 464-8681, Japan

RECRUITING

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

CisplatinRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial

    Johnson & Johnson Enterprise Innovation Inc.

    STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210Participate-In-This-Study1@its.jnj.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2025

First Posted

October 21, 2025

Study Start

January 26, 2026

Primary Completion (Estimated)

July 14, 2028

Study Completion (Estimated)

July 14, 2028

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

More information

Locations

US(8)FR(5)JP(3)