What this study is
The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.
What's being tested
- JNJ-87704916
Intervention · DRUG
JNJ-87704916 will be administered as an intratumoral injection.
- Cetrelimab
Intervention · DRUG
Cetrelimab will be administered.
- Standard of Care PD(L)-1
Intervention · DRUG
Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.
Study details
- Official title
- Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
- Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Conditions
- Neoplasms
- Enrolling
- 126 people
- Starts
- 2024-04-10
- Est. completion
- 2033-02-14
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
- Have at least 1 injectable tumor
- Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
- A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
- Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
You can't join if
- Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
- Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
- Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
- History of solid organ or hematologic stem cell transplantation
- Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
- History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
9 openNYU Langone Health
New York, New York, United States
RecruitingUPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
RecruitingFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Suspended
6 sites outside the US
Toronto General Hospital
Toronto, Ontario, Canada
RecruitingCentre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
RecruitingGustave Roussy
Villejuif, France
RecruitingHosp Univ Vall D Hebron
Barcelona, Spain
RecruitingHosp Univ Fund Jimenez Diaz
Madrid, Spain
RecruitingHosp Univ Hm Sanchinarro
Madrid, Spain
Recruiting
Study team
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Study ID 87704916LUC1001
Study director
Johnson & Johnson Enterprise Innovation Inc Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.