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RECRUITING
NCT06095089
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

355

Start Date

2023-11-01

Completion Date

2028-06-28

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DRUG

JNJ-78278343

JNJ-78278343 will be administered.

DRUG

JNJ-87189401

JNJ-87189401 will be administered.

DRUG

Apalutamide

Apalutamide will be administered.

DRUG

Lutetium Lu-177 Vipivotide Tetraxetan

Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.

DRUG

JNJ-101556143

JNJ-101556143 will be administered.

Locations (13)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University Of Minnesota

Minneapolis, Minnesota, United States

START New Jersey

East Brunswick, New Jersey, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, United States

Oregon Health And Science University

Portland, Oregon, United States

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Institut Bergonie

Bordeaux, France

Centre Leon Berard

Lyon, France

Institut Gustave Roussy

Villejuif, France

The Cancer Institute Hospital of JFCR

Tokyo, Japan