The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
JNJ-80038114 will be administered.
University Of Minnesota
Minneapolis, Minnesota, United States
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University College London Hospitals NHSFT
London, United Kingdom
Parts 1 and 2: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 2 Years 6 Months
Parts 1 and 2: Number of Participants With AEs by Severity
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) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Time frame: Up to 2 Years 6 Months
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time frame: Up to 2 Years 6 Months
Serum Concentration of JNJ-80038114
Serum concentration of JNJ-80038114 will be determined.
Time frame: Up to 2 Years 6 Months
Systemic Cytokine Concentrations
Cytokine concentrations will be determined for biomarker assessment.
Time frame: Up to 2 Years 6 Months
Serum Prostate Specific Antigen (PSA) Concentration
Serum PSA concentration will be determined.
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The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
Time frame: Up to 2 Years 6 Months
Number of Participants With Antibodies to JNJ-80038114
Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 using a validated assay method.
Time frame: Up to 2 Years 6 Months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according to Prostate Cancer Working Group 3 (PCWG3) response criteria.
Time frame: Up to 2 Years 6 Months
PSA Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline in PSA of 50 percent (%) or more from baseline.
Time frame: Up to 2 Years 6 Months
Duration of Response (DOR)
DOR is defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 response criteria, or death due to any cause, whichever occurs first.
Time frame: Up to 2 Years 6 Months