Neoplasms
Conditions
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.
Interventions
DRUGJNJ-87704916
JNJ-87704916 will be administered as an intratumoral injection.
DRUGCetrelimab
Cetrelimab will be administered.
Sponsors
Johnson & Johnson Enterprise Innovation Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 except for participants on thyroid hormone replacement therapy
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 allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) | Up to 5 years | The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 for at least 2 consecutive assessments 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. |
Countries
Canada, France, Spain, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Enterprise Innovation Inc Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed