NCT06311578 A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
| NCT ID | NCT06311578 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johnson & Johnson Enterprise Innovation Inc. |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2028-11-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 126 participants in total. It began in 2024-04-10 with a primary completion date of 2028-11-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Johnson & Johnson Enterprise Innovation Inc Clinical Trial
STUDY DIRECTOR
Johnson & Johnson Enterprise Innovation Inc.
Frequently Asked Questions
Who can join the NCT06311578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06311578 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06311578 currently recruiting?
Yes, NCT06311578 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT06311578 trial being conducted?
This trial is being conducted at New York, United States, Philadelphia, United States, Pittsburgh, United States, Houston, United States and 6 additional locations.
Who is sponsoring the NCT06311578 clinical trial?
NCT06311578 is sponsored by Johnson & Johnson Enterprise Innovation Inc.. The principal investigator is Johnson & Johnson Enterprise Innovation Inc Clinical Trial at Johnson & Johnson Enterprise Innovation Inc.. The trial plans to enroll 126 participants.