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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311578
• Other study ID #: 87704916LUC1001
• Secondary ID: 2023-506495-27-0
• Status: Recruiting
• Phase: Phase 1
• Start date: April 10, 2024
• Est. completion date: November 30, 2033

Study information

• Verified date: April 2024
• Source: Johnson & Johnson Enterprise Innovation Inc.
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: November 30, 2033
• Est. primary completion date: November 8, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• JNJ-87704916
JNJ-87704916 will be administered as an intratumoral injection.
• Cetrelimab
Cetrelimab will be administered.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Enterprise Innovation Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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