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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: JNJ-87704916
    JNJ-87704916 will be administered as an intratumoral injection.
  • Drug: Cetrelimab
    Cetrelimab will be administered.
    Other names:
    • JNJ-63723283
Experimental
Part 2: Dose Expansion 		Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC.
  • Drug: JNJ-87704916
    JNJ-87704916 will be administered as an intratumoral injection.
  • Drug: Cetrelimab
    Cetrelimab will be administered.
    Other names:
    • JNJ-63723283
  • Drug: Standard of Care PD(L)-1
    Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.

Recruiting Locations

NYU Langone Health
New York, New York 10016

UPMC Cancer Centers
Pittsburgh, Pennsylvania 15232

MD Anderson Cancer Center
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Johnson & Johnson Enterprise Innovation Inc.

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.