A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed * Measurable or evaluable disease per PCWG3 criteria * Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of…
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.
Locations (13)
- University of Colorado Anschutz Medical CampusAurora, Colorado
- University Of MinnesotaMinneapolis, Minnesota
- START New JerseyEast Brunswick, New Jersey
- Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew York, New York
- Oregon Health And Science UniversityPortland, Oregon
- Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphia, Pennsylvania