RecruitingPhase 1NCT06311578

A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

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.

Enrollment

96 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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)

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Interventions

DRUGJNJ-87704916

JNJ-87704916 will be administered as an intratumoral injection.

DRUGCetrelimab

Cetrelimab will be administered.


Locations(10)

NYU Langone Health

New York, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Toronto General Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Gustave Roussy

Villejuif, France

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06311578


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