NCT06311578PHASE1Recruiting
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
Johnson & Johnson Enterprise Innovation Inc.
Start Date
4/10/2024
Completion Date
2/14/2033
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Interventions
DRUG
JNJ-87704916
DRUG
Cetrelimab
DRUG
Standard of Care PD(L)-1
Conditions
Neoplasms
Locations
NYU Langone Health
New York, New York 10016
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania 15232
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Toronto General Hospital
Toronto, Ontario M5G 2C4
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec H2X 0A9
Canada
Gustave Roussy
Villejuif, 94805
France
Hosp Univ Vall D Hebron
Barcelona, 08035
Spain
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Spain
Hosp Univ Hm Sanchinarro
Madrid, 28050
Spain