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NCT Number: NCT06311578

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto General Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

JNJ-87704916

Drug

JNJ-87704916 will be administered as an intratumoral injection.

Cetrelimab

Drug

Cetrelimab will be administered.

Other names: JNJ-63723283

Standard of Care PD(L)-1

Drug

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

Primary outcomes

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

    Time frame: Up to 5 years

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

  2. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Parts 1 and 2: Duration of Response (DOR)

    Time frame: 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.

  4. 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)

    PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause.

  5. Part 2: Overall Survival (OS)

    Time frame: 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.

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

    Time frame: 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.

  7. Parts 1 and 2: Payload Concentrations of JNJ-87704916

    Time frame: Up to 2 years

    Blood samples will be collected to characterize JNJ-87704916 payload concentrations in blood will be analyzed using immunoassay.

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

    Time frame: Up to 2 years

    Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2033
First posted
Mar 15, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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