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

Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Cetrelimab; Drug: JNJ-87704916

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy
• 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Cetrelimab; Cetrelimab will be administered.; Other Names: JNJ-63723283; Drug: JNJ-87704916; JNJ-87704916 will be administered as an intratumoral injection.
Experimental: Part 2 Cohort A: Dose Expansion; Participants with relapsed/refractory metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Additional cohorts may be added to evaluate additional disease indications, or treatment regimens.	Drug: Cetrelimab; Cetrelimab will be administered.; Other Names: JNJ-63723283; Drug: JNJ-87704916; JNJ-87704916 will be administered as an intratumoral injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)	The DLTs are specific adverse events and are defined as any of the following: non-hematological toxicity and hematologic toxicity.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1 and 2: Percentage of Participants With Objective Response (OR)	OR is defined as the percentage of participants who have best response of Complete Response (CR) or Partial Response (PR) according to response evaluation criteria in solid tumors (RECIST) v1.1.	Up to 5 years
Parts 1 and 2: Percentage of Participants With Disease Control (DC)	DC is defined as the percentage of participants who have achieved complete response, partial response, and stable disease according to RECIST v1.1.	Up to 5 years
Parts 1 and 2: Duration of Response (DOR)	DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first.	Up to 5 years
Part 2: Progression Free Survival (PFS)	PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause.	From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)
Part 2: Overall Survival (OS)	OS is defined as the time from treatment initiation until death due to any cause.	From treatment initiation until death due to any cause (up to 5 years)
Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter	Viral genome copies of JNJ-87704916 collected from samples (that is, blood, urine, oral mucosa, injection sites, and dressings) will be determined by quantitative polymerase chain reaction (qPCR) assays.	Up to 5 years
Parts 1 and 2: Payload Concentrations of JNJ-87704916	Blood samples will be collected to characterize JNJ-87704916 payload concentrations in blood and tumor and will be analyzed using immunoassay.	Up to 2 years
Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies	Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed.	Up to 2 years

Collaborators and Investigators

• Sponsor: Johnson & Johnson Enterprise Innovation Inc.
• Investigators: Study Director: Johnson & Johnson Enterprise Innovation Inc Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): November 8, 2028
• Study Completion (Estimated): November 30, 2033

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 87704916LUC1001; 2023-506495-27-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes