Phase I Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
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Study 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.
Safety was evaluated through the incidence of adverse events, and lab abnormalities. Efficacy was evaluated through CT scans every 6 weeks, according to RECIST 1.1 criteria. Pharmacokinetics and PD were assessed in blood and tumor samples collected at pre-specified timepoints.
- 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 NSCLCHave at least 1 injectable tumorEastern cooperative oncology group (ECOG) performance status of grade 0 or 1A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the studyThyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
- Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowedPrior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapyActive 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 agentsHistory of solid organ or hematologic stem cell transplantationKnown positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndromeHistory of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
Clinical Study Information for Healthcare Providers
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