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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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 study drug and must continue this therapy throughout the treatment phase - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

  • History of an autoimmune disease within the 12 months prior to signing consent - Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Drug: JNJ-78278343
    JNJ-78278343 will be administered.
    Other names:
    • KLK2-CD3
    • Pasritamig
  • Drug: JNJ-87189401
    JNJ-87189401 will be administered.
    Other names:
    • PSMAxCD28
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.
  • Drug: JNJ-78278343
    JNJ-78278343 will be administered.
    Other names:
    • KLK2-CD3
    • Pasritamig
  • Drug: JNJ-87189401
    JNJ-87189401 will be administered.
    Other names:
    • PSMAxCD28
  • Drug: Apalutamide
    Apalutamide will be administered.
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.
  • Drug: JNJ-78278343
    JNJ-78278343 will be administered.
    Other names:
    • KLK2-CD3
    • Pasritamig
  • Drug: JNJ-87189401
    JNJ-87189401 will be administered.
    Other names:
    • PSMAxCD28
  • Drug: Lutetium Lu-177 Vipivotide Tetraxetan
    Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
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.
  • Drug: JNJ-78278343
    JNJ-78278343 will be administered.
    Other names:
    • KLK2-CD3
    • Pasritamig
  • Drug: JNJ-87189401
    JNJ-87189401 will be administered.
    Other names:
    • PSMAxCD28
  • Drug: JNJ-101556143
    JNJ-101556143 will be administered.
    Other names:
    • HLD-0915

Recruiting Locations

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

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.