> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-jnj-87704916-as-monotherapy-and-in-combination-599bfae9-0946-4165-8607-b2cacc5f18c5 > Record changed: 2026-11-04 # A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors NCT06311578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) Participants 126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) Lead sponsor Johnson & Johnson Enterprise Innovation Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) Start date 2024-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) Number of sites 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Short title** A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Official title** Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Dates **Completion date** 2033-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **First posted** 2024-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Registry last updated** 2026-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Primary completion date** 2028-11-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Start date** 2024-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Size and sites **Participants** 126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Planned participants** 126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Number of sites** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Lead sponsor** Johnson & Johnson Enterprise Innovation Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Identifiers **Registry ID** NCT06311578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **ClinicalTrials.gov ID** NCT06311578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Outcomes ### Primary outcomes 1. 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. 2. 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. ### Secondary outcomes 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Sites - NYU Langone HealthNew York, United StatesRecruiting - Fox Chase Cancer CenterPhiladelphia, United StatesSuspended - UPMC Cancer CentersPittsburgh, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - Toronto General HospitalToronto, CanadaRecruiting - Centre Hospitalier de l'Universite de MontrealMontreal, CanadaRecruiting - Gustave RoussyVillejuif, FranceRecruiting - Hosp Univ Vall D HebronBarcelona, SpainRecruiting - Hosp Univ Fund Jimenez DiazMadrid, SpainRecruiting - Hosp Univ Hm SanchinarroMadrid, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## References ### Other registry identifiers (2) - 2023 - 2023-506495-27-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06311578) ## Related records ### Drugs (1) - [Cetrelimab](https://trialight.com/data/asset/cetrelimab-3efc0fa4-bffb-4b48-bdc8-d69f58f2bb03.md) ### Lead sponsors (1) - [Johnson & Johnson Enterprise Innovation Inc.](https://trialight.com/data/company/johnson-johnson-enterprise-innovation-inc-17efc36f-cdf1-4c88-a056-bfdb8d736efb.md) ### Conditions (1) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) Primary condition ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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