JNJ-87704916
DrugJNJ-87704916 will be administered as an intratumoral injection.
NCT Number: NCT06311578
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Toronto General Hospital, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-87704916 will be administered as an intratumoral injection.
Cetrelimab will be administered.
Other names: JNJ-63723283
Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.
Time frame: Up to 5 years
The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
Time frame: 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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)
PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause.
Time frame: From treatment initiation until death due to any cause (up to 5 years)
OS is defined as the time from treatment initiation until death due to any cause.
Time frame: Up to 5 years
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.
Time frame: Up to 2 years
Blood samples will be collected to characterize JNJ-87704916 payload concentrations in blood will be analyzed using immunoassay.
Time frame: Up to 2 years
Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed.
Contact information is provided by the study sponsor or research team.
Johnson & Johnson Enterprise Innovation Inc.
Industry
Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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