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
Johnson & Johnson Enterprise Innovation Inc.
126 participants
Apr 10, 2024
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
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
JNJ-87704916 will be administered as an intratumoral injection.
Cetrelimab will be administered.
Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06311578