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RecruitingInterventionalPhase 1

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

NCT ID: NCT06311578Sponsor: Johnson & Johnson Enterprise Innovation Inc.Last updated: 2026-06-05

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.

Arms & interventions

  • DrugJNJ-87704916

    JNJ-87704916 will be administered as an intratumoral injection.

  • DrugCetrelimab

    Cetrelimab will be administered.

  • DrugStandard of Care PD(L)-1

    Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.

Outcome measures

Primary

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

    The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.

    Time frame: Up to 5 years

  • Number of Participants with Adverse Events (AEs) by Severity

    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.

    Time frame: From first dose up to 100 days after last dose of study treatment (up to 5 years)

Secondary

  • Parts 1 and 2: Percentage of Participants With Objective Response (OR)

    Time frame: Up to 5 years

  • Parts 1 and 2: Percentage of Participants With Disease Control (DC)

    Time frame: Up to 5 years

  • Parts 1 and 2: Duration of Response (DOR)

    Time frame: Up to 5 years

  • Part 2: Progression Free Survival (PFS)

    Time frame: From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)

  • Part 2: Overall Survival (OS)

    Time frame: From treatment initiation until death due to any cause (up to 5 years)

  • Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter

    Time frame: Up to 5 years

  • Parts 1 and 2: Payload Concentrations of JNJ-87704916

    Time frame: Up to 2 years

  • Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies

    Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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)

Study locations (4)

NYU Langone Health

New York, New York, 10016

Recruiting

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Suspended

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting