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.

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

Neoplasms

Cancer

Cetrelimab

JNJ-87704916

Standard of Care PD(L)-1

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

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

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.

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.

DC is defined as the percentage of participants who have achieved complete response, partial response, and stable disease for at least 2 consecutive assessments according to RECIST v1.1.

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.

PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause.

OS is defined as the time from treatment initiation until death due to any cause.

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.

Blood samples will be collected to characterize JNJ-87704916 payload concentrations in blood will be analyzed using immunoassay.

Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed.

Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.

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.

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.

NYU Langone Health

Fox Chase Cancer Center

UPMC Cancer Centers

MD Anderson Cancer Center

Gustave Roussy

Hosp Univ Vall D Hebron

Hosp Univ Fund Jimenez Diaz

Hosp Univ Hm Sanchinarro

The DLTs are specific adverse events and are defined as any of the following:
non-hematological toxicity and hematologic toxicity.

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.

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.

DC is defined as the percentage of participants who have achieved complete response,
partial response, and stable disease according to RECIST v1.1.

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.

PFS is defined as the time from treatment initiation until disease progression or
worsening or death due to any cause.

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.

Blood samples will be collected to characterize JNJ-87704916 payload concentrations in
blood will be analyzed using immunoassay.

Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1
(HSV-1) will be analyzed.

Participants with advanced solid tumors will receive JNJ-87704916 alone and in
combination with cetrelimab. Ascending dose levels will be sequentially tested.

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.

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

Trials at a glance

Trials at a glance