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

Launched by JOHNSON & JOHNSON ENTERPRISE INNOVATION INC. · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called JNJ-87704916 for people with advanced solid tumors, which are cancers that have spread beyond their original site. The study aims to find out how safe this treatment is, what the best dose might be, and how well it works when given alone or in combination with another medication called cetrelimab. The trial is currently recruiting participants who meet specific criteria, such as having a type of cancer that has not responded to standard treatments and having at least one tumor that can be injected for testing.

To be eligible for the trial, participants generally need to be between the ages of 65 and 74 and have a confirmed diagnosis of advanced or metastatic solid tumor. They should also be in good overall health, as indicated by a performance status score of 0 or 1, which means they are fully active or only slightly limited in their daily activities. Participants can expect to undergo careful monitoring during the study, which includes regular check-ups and tests to assess their health and how their body responds to the treatment. It’s important for potential participants to know that the study has specific exclusions for certain health conditions, such as active infections or a history of serious allergic reactions to medications.

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ALL

Eligibility criteria

• 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
• Exclusion Criteria:
• • 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)