Recruiting
Phase 1

JNJ-87704916 & Cetrelimab

Sponsor:

Johnson & Johnson Enterprise Innovation Inc.

Code:

NCT06311578

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-87704916

Cetrelimab

Standard of Care PD(L)-1

Study Details

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.

Conditions

Neoplasms

Study ID

NCT06311578

Start date

Apr 10, 2024

Status verified date

Aug, 2026

Completion date

Feb 14, 2033

Anticipated

Primary completion date

Nov 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

126 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

JNJ-87704916

JNJ-87704916 will be administered as an intratumoral injection.

Cetrelimab

Cetrelimab will be administered.

Standard of Care PD(L)-1

Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.

Primary outcome measure

  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 5 years ]
  • Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: From first dose up to 100 days after last dose of study treatment (up to 5 years) ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

UPMC Cancer Centers

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

More Information

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johnson & Johnson Enterprise Innovation Inc. on 2026-08-28.