Clinical trial NCT06311578: A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
Official title: Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Johnson & Johnson Enterprise Innovation Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
timeFrame: Up to 5 years
measure: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: From first dose up to 100 days after last dose of study treatment (up to 5 years)
Secondary outcomes:
measure: Parts 1 and 2: Percentage of Participants With Objective Response (OR)
timeFrame: Up to 5 years
measure: Parts 1 and 2: Percentage of Participants With Disease Control (DC)
timeFrame: Up to 5 years
measure: Parts 1 and 2: Duration of Response (DOR)
timeFrame: Up to 5 years
measure: Part 2: Progression Free Survival (PFS)
timeFrame: From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)
measure: Part 2: Overall Survival (OS)
timeFrame: From treatment initiation until death due to any cause (up to 5 years)
measure: Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter
timeFrame: Up to 5 years
measure: Parts 1 and 2: Payload Concentrations of JNJ-87704916
timeFrame: Up to 2 years
measure: Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Villejuif
country: France
facility: Gustave Roussy
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
Study officials:
affiliation: Johnson & Johnson Enterprise Innovation Inc.
name: Johnson & Johnson Enterprise Innovation Inc Clinical Trial
role: STUDY_DIRECTOR
References: