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NCT06095089PHASE1Recruiting

A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

Janssen Research & Development, LLC

Start Date

11/1/2023

Completion Date

6/28/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-78278343

DRUG

JNJ-87189401

DRUG

Apalutamide

DRUG

Lutetium Lu-177 Vipivotide Tetraxetan

DRUG

JNJ-101556143

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Conditions

Prostatic Neoplasms

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

Emory University Winship Cancer Institute

Atlanta, Georgia 30322

United States

University Of Minnesota

Minneapolis, Minnesota 55455

United States

START New Jersey

East Brunswick, New Jersey 08816

United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York 10032

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania 19107

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas 78229

United States

Swedish Medical Center

Seattle, Washington 98104

United States

Greenslopes Private Hospital

Greenslopes, 4120

Australia

Peter MacCallum Cancer Centre

Melbourne, 3000

Australia

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Institut Bergonie

Bordeaux, 33000

France

Centre Leon Berard

Lyon, 69008

France

Institut Gustave Roussy

Villejuif, 94800

France

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550

Japan