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Recruiting Phase 1

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

NCT06311578 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2024-04-10
Last updated
2026-11-03

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

JNJ-87704916Cetrelimab →Standard of Care PD(L)-1

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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)

Primary outcome measure(s)

  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) — Up to 5 years
    The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
  • Number of Participants with Adverse Events (AEs) by Severity — From first dose up to 100 days after last dose of study treatment (up to 5 years)
    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.

Trial sites (10)

FacilityCityRegionStatus
NYU Langone Health New York New York Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Suspended
UPMC Cancer Centers Pittsburgh Pennsylvania Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Toronto General Hospital Toronto Ontario Recruiting
Centre Hospitalier de l'Universite de Montreal Montreal Quebec Recruiting
Gustave Roussy Villejuif France Recruiting
Hosp Univ Vall D Hebron Barcelona Spain Recruiting
Hosp Univ Fund Jimenez Diaz Madrid Spain Recruiting
Hosp Univ Hm Sanchinarro Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06311578 on ClinicalTrials.gov ↗ ← All trials in the USA