A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
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.
Arms & interventions
- DrugJNJ-78278343
JNJ-78278343 will be administered.
- DrugJNJ-87189401
JNJ-87189401 will be administered.
- DrugApalutamide
Apalutamide will be administered.
- DrugLutetium Lu-177 Vipivotide Tetraxetan
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
- DrugJNJ-101556143
JNJ-101556143 will be administered.
Outcome measures
Primary
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
Secondary
Serum Concentrations of JNJ-87189401 and JNJ-78278343
Time frame: Up to 4 years 8 months
Plasma Concentration of JNJ-101556143
Time frame: Up to 4 years 8 months
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Time frame: Up to 4 years 8 months
Objective Response Rate (ORR)
Time frame: Up to 4 years 8 months
Radiographic Progression-Free Survival (rPFS)
Time frame: Up to 4 years 8 months
Prostate Specific Antigen (PSA) Response Rate
Time frame: Up to 4 years 8 months
Duration of Response (DOR)
Time frame: Up to 4 years 8 months
Eligibility criteria
Study locations (11)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
University Of Minnesota
Minneapolis, Minnesota, 55455
START New Jersey
East Brunswick, New Jersey, 08816
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
Oregon Health And Science University
Portland, Oregon, 97239
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107
Tennessee Oncology
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229
Swedish Medical Center
Seattle, Washington, 98104