A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

NCT06311578 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 87704916LUC10012023-506495-27-00
• Study Type: interventional
• Target: 96
• Locations: 4 countries
• Sites: 10

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

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

  The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.

  Up to 5 years

• Number of Participants with Adverse Events (AEs) by Severity

  An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.

  From first dose up to 100 days after last dose of study treatment (up to 5 years)

Secondary Outcomes (8)

• Parts 1 and 2: Percentage of Participants With Objective Response (OR)

  Up to 5 years

• Parts 1 and 2: Percentage of Participants With Disease Control (DC)

  Up to 5 years

• Parts 1 and 2: Duration of Response (DOR)

  Up to 5 years

• Part 2: Progression Free Survival (PFS)

  From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)

• Part 2: Overall Survival (OS)

  From treatment initiation until death due to any cause (up to 5 years)

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

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; Drug: Cetrelimab

Part 2: Dose Expansion

EXPERIMENTAL

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.

Drug: JNJ-87704916; Drug: Cetrelimab

Interventions

Cetrelimab DRUG

Cetrelimab will be administered.

Also known as: JNJ-63723283

Part 1: Dose Escalation; Part 2: Dose Expansion

JNJ-87704916 DRUG

JNJ-87704916 will be administered as an intratumoral injection.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Enterprise Innovation Inc.: lead

Study Sites (10)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Johnson & Johnson Enterprise Innovation Inc Clinical Trial

  Johnson & Johnson Enterprise Innovation Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): November 8, 2028
• Study Completion (Estimated): August 26, 2032
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); US (4); CA (2); ES (3)