A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 study drug and must continue this therapy throughout the treatment phase
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Georgia
Emory University Winship Cancer Institute
RECRUITING
Atlanta
Minnesota
University Of Minnesota
RECRUITING
Minneapolis
New Jersey
START New Jersey
RECRUITING
East Brunswick
New York
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
RECRUITING
New York
Oregon
Oregon Health And Science University
RECRUITING
Portland
Pennsylvania
Sidney Kimmel Cancer Center - Jefferson Health
RECRUITING
Philadelphia
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
South Texas Accelerated Research Therapeutics, LLC (START)
RECRUITING
San Antonio
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
Institut Gustave Roussy
RECRUITING
Villejuif
Japan
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2023-11-01
Estimated Completion Date:2028-06-28
Participants
Target number of participants:355
Treatments
Experimental: Part 1 (Dose Escalation)
Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R).
Experimental: Part 2 (Dose Expansion)
Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet.
Experimental: Part 3
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision.
Experimental: Part 4
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations.