Informations générales (source: ClinicalTrials.gov)
Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
Interventional
Phase 1
Johnson & Johnson Enterprise Innovation Inc. (Voir sur ClinicalTrials)
avril 2024
novembre 2033
19 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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 Grade 3 or higher toxic effects during prior treatment with immunotherapy
or requirement of anti-tumor necrosis factor (TNF) or anti-interleukin 6 (IL-6)
agents to manage AEs from prior treatment with immunotherapy
- History of allergy to protein-based therapies or history of any significant drug
allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or
anemia)