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

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.
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Short title: A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
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Official title: Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
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Control arm: Open label
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Registry reports results: No
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Listing at source: Listed
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Recruitment status: Recruiting
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Phase: Phase 1
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Study type: Interventional
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Completion date: 2033-02-14
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First posted: 2024-03-15
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Registry last updated: 2026-09-25
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Primary completion date: 2028-11-08
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Start date: 2024-04-10
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Participants: 126
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Participant count basis: Estimated
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Planned participants: 126
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Protocol amendments: 4
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Number of sites: 10
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Data monitoring committee: No
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Registry sponsor category: Industry
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Lead sponsor: Johnson & Johnson Enterprise Innovation Inc.
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Source registry: ClinicalTrials.gov
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Registry ID: NCT06311578
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ClinicalTrials.gov ID: NCT06311578
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Registry record: Open registry record
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Allocation: Not randomised
Model: Sequential
Purpose: Treatment
Masking: No masking

Sources for study design

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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Timeframe: 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
Timeframe: 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.

Parts 1 and 2: Percentage of Participants With Objective Response (OR)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Up to 2 years
Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed.

Sources for outcomes

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Sex: All
Age groups: Adults, Older adults
Minimum age: 18 Years
Healthy volunteers: No

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

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)

Sources for eligibility

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