RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors

Quick Facts

Study Start:2024-04-10

Study Completion:2033-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06311578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

CONTACT

844-434-4210

Participate-In-This-Study@its.jnj.com

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc Clinical Trial

STUDY_DIRECTOR

Johnson & Johnson Enterprise Innovation Inc.

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Johnson & Johnson Enterprise Innovation Inc Clinical Trial, STUDY_DIRECTOR, Johnson & Johnson Enterprise Innovation Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-10

Study Completion Date2033-11-30

Study Record Updates

Study Start Date2024-04-10

Study Completion Date2033-11-30

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumors