The purpose of this study is to determine recommended Phase 2 dose (RP2D) regimen(s) of JNJ-75229414 in Part 1 (Dose Escalation and to determine safety at the RP2D regimen(s) in Part 2 (Dose Expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
15
JNJ-75229414 infusion will be administered intravenously.
Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be administered intravenously.
City of Hope Cancer Center
Duarte, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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 15 years 9 months
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.
Time frame: Up to 15 years 9 months
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Number of participants with DLT will be assessed. 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 28 days
Maximum Observe Plasma Concentration (Cmax) of JNJ-75229414
Cmax is the maximum observed plasma concentration of JNJ-75229414.
Time frame: Up to 15 years 9 months
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75229414
Tmax is the actual sampling time to reach maximum observed plasma concentration of JNJ-75229414.
Time frame: Up to 15 years 9 months
Area Under Plasma Concentration Versus Time Curve from Time Zero to t Time (AUC[0-t]) of JNJ-75229414
AUC(0-t) is the area under the plasma concentration versus time curve from time zero to 't' time.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Columbia University Medical Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Time frame: Up to 15 years 9 months
Peripheral T Cell Expansion and Persistence via Monitoring Chimeric Antigen Receptor T (CAR-T) Positive Cell Counts
Peripheral T cell expansion and persistence via monitoring CAR-T positive cell counts will be reported.
Time frame: Up to 15 years 9 months
Number of Participants With Presence of Anti-JNJ-75229414 Antibodies
Number of participants with antibodies to JNJ-75229414 will be reported.
Time frame: Up to 15 years 9 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve a confirmed best overall response of Complete Response (CR) or Partial Response (PR) evaluated by an independent local radiology review based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Prostate Cancer Working Group 3 (PCWG3) criteria will be used to assess progressive bone metastases.
Time frame: Up to 15 years 9 months
Disease Control Rate (DCR)
DCR is defined as the sum of CR, PR, and stable disease (SD).
Time frame: Up to 15 years 9 months
Duration of Response (DoR)
DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.
Time frame: Up to 15 years 9 months
Time to response (TTR)
TTR defined as the time from the date of first dose of study drug to the date of first documented response.
Time frame: Up to 15 years 9 months
Peripheral Blood Quantitation of Vesicular Stomatitis Virus G glycoprotein (VSV-G) Copy Numbers
Peripheral blood quantitation of VSV-G copy numbers will be reported.
Time frame: Up to 15 years 9 months