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A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
Sponsor: Janssen Research & Development, LLC
Summary
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.
Official title: A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
355
Start Date
2023-11-01
Completion Date
2028-06-28
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
JNJ-78278343
JNJ-78278343 will be administered.
JNJ-87189401
JNJ-87189401 will be administered.
Apalutamide
Apalutamide will be administered.
Lutetium Lu-177 Vipivotide Tetraxetan
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
JNJ-101556143
JNJ-101556143 will be administered.
Locations (13)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University Of Minnesota
Minneapolis, Minnesota, United States
START New Jersey
East Brunswick, New Jersey, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
Oregon Health And Science University
Portland, Oregon, United States
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Institut Bergonie
Bordeaux, France
Centre Leon Berard
Lyon, France
Institut Gustave Roussy
Villejuif, France
The Cancer Institute Hospital of JFCR
Tokyo, Japan