A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
NCT ID: NCT06311578
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
96 participants
INTERVENTIONAL
2024-04-10
2032-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.
JNJ-87704916
JNJ-87704916 will be administered as an intratumoral injection.
Cetrelimab
Cetrelimab will be administered.
Part 2: Dose Expansion
Part 2 will consist of two cohorts: Cohort A and Cohort B. Participants in both Cohorts with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1.
JNJ-87704916
JNJ-87704916 will be administered as an intratumoral injection.
Cetrelimab
Cetrelimab will be administered.
Interventions
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JNJ-87704916
JNJ-87704916 will be administered as an intratumoral injection.
Cetrelimab
Cetrelimab will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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 Grade 3 or higher toxic effects during prior treatment with immunotherapy or requirement of anti-tumor necrosis factor (TNF) or anti-interleukin 6 (IL-6) agents to manage AEs from prior treatment with immunotherapy
* History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
18 Years
ALL
No
Sponsors
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Johnson & Johnson Enterprise Innovation Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Enterprise Innovation Inc Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Enterprise Innovation Inc.
Locations
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NYU Langone Health
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Toronto General Hospital
Toronto, Ontario, Canada
Gustave Roussy
Villejuif, , France
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Hosp Univ Hm Sanchinarro
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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87704916LUC1001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506495-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
87704916LUC1001
Identifier Type: -
Identifier Source: org_study_id