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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

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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