The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
355
JNJ-78278343 will be administered.
JNJ-87189401 will be administered.
Apalutamide will be administered.
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
JNJ-101556143 will be administered.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGEmory University Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGUniversity Of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGSTART New Jersey
East Brunswick, New Jersey, United States
RECRUITINGHerbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
RECRUITINGAtrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGOregon Health And Science University
Portland, Oregon, United States
RECRUITINGSidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITING...and 9 more locations
Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Time frame: Up to 21 days after first combination dose of study drugs
Number of Participants with Adverse Events (AEs) by Severity
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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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 4 years 8 months
Serum Concentrations of JNJ-87189401 and JNJ-78278343
Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343.
Time frame: Up to 4 years 8 months
Plasma Concentration of JNJ-101556143
Plasma samples will be analyzed to determine concentrations of JNJ-101556143.
Time frame: Up to 4 years 8 months
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.
Time frame: Up to 4 years 8 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
Time frame: Up to 4 years 8 months
Radiographic Progression-Free Survival (rPFS)
rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first.
Time frame: Up to 4 years 8 months
Prostate Specific Antigen (PSA) Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
Time frame: Up to 4 years 8 months
Duration of Response (DOR)
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
Time frame: Up to 4 years 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.