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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06311578
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