Testing JNJ-87704916 for advanced solid tumors
Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
This study is testing a new treatment called JNJ-87704916, alone and with another drug, to see if it can help people with advanced solid tumors feel better and improve their health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johnson & Johnson Enterprise Innovation Inc. Industry-sponsored |
| Drugs / interventions | cetrelimab |
| Locations | 10 sites (New York, New York and 9 other locations) |
| Trial ID | NCT06311578 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of JNJ-87704916, both alone and in combination with cetrelimab, for patients with advanced solid tumors. It aims to identify the recommended doses and treatment regimens for these therapies. Participants will be monitored for their response to the treatment and any potential side effects. The study is divided into two parts, focusing on different patient populations with advanced cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors who have no remaining standard treatment options.
Not a fit: Patients with active central nervous system involvement or significant herpetic infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York and 9 other locations
- NYU Langone Health — New York, New York, United States (Recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Suspended)
- UPMC Cancer Centers — Pittsburgh, Pennsylvania, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
- Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
- Hosp Univ Vall D Hebron — Barcelona, Spain (Recruiting)
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain (Recruiting)
- Hosp Univ Hm Sanchinarro — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.