A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
- Registration Number
- NCT06311578
- Lead Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation JNJ-87704916 Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested. Part 1: Dose Escalation Cetrelimab Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested. Part 2: Dose Expansion JNJ-87704916 Part 2 will consist of two cohorts: Cohort A and Cohort B. Participants in both Cohorts with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Part 2: Dose Expansion Cetrelimab Part 2 will consist of two cohorts: Cohort A and Cohort B. Participants in both Cohorts with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1.
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) Up to 5 years The DLTs are specific adverse events and are defined as any of the following: non-hematological toxicity and hematologic toxicity.
Number of Participants with Adverse Events (AEs) by Severity From first dose up to 100 days after last dose of study treatment (up to 5 years) An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
- Secondary Outcome Measures
Name Time Method Parts 1 and 2: Percentage of Participants With Objective Response (OR) Up to 5 years OR is defined as the percentage of participants who have best response of Complete Response (CR) or Partial Response (PR) according to response evaluation criteria in solid tumors (RECIST) v1.1.
Parts 1 and 2: Percentage of Participants With Disease Control (DC) Up to 5 years DC is defined as the percentage of participants who have achieved complete response, partial response, and stable disease according to RECIST v1.1.
Parts 1 and 2: Duration of Response (DOR) Up to 5 years DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first.
Part 2: Progression Free Survival (PFS) From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years) PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause.
Part 2: Overall Survival (OS) From treatment initiation until death due to any cause (up to 5 years) OS is defined as the time from treatment initiation until death due to any cause.
Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter Up to 5 years Viral genome copies of JNJ-87704916 collected from samples (that is, blood, urine, oral mucosa, injection sites, and dressings) will be determined by quantitative polymerase chain reaction (qPCR) assays.
Parts 1 and 2: Payload Concentrations of JNJ-87704916 Up to 2 years Blood samples will be collected to characterize JNJ-87704916 payload concentrations in blood will be analyzed using immunoassay.
Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies Up to 2 years Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed.
Trial Locations
- Locations (7)
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Gustave Roussy
🇫🇷Villejuif, France
Hosp Univ Fund Jimenez Diaz
🇪🇸Madrid, Spain
Hosp Univ Hm Sanchinarro
🇪🇸Madrid, Spain