RecruitingPhase 1NCT06095089

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

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


Sponsor

Janssen Research & Development, LLC

Enrollment

355 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two experimental cancer drugs — JNJ-87189401 and JNJ-78278343 — in patients with advanced prostate cancer that has stopped responding to standard hormone-based treatments. The study is in early phases to assess safety and find the right dosing. **You may be eligible if...** - You have been diagnosed with prostate adenocarcinoma (the most common type of prostate cancer) - Your cancer is measurable or evaluable on scans - Your testosterone has been suppressed to castrate levels (through surgery or ongoing hormone therapy) - You are in good enough health to carry out daily activities (ECOG 0-1) **You may NOT be eligible if...** - You have active autoimmune disease - You have pure small cell, carcinoid, or large cell neuroendocrine prostate cancer (mixed types may be permitted) - You have significant heart, liver, or kidney problems - You have had certain prior treatments that would conflict with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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

View Full Details on ClinicalTrials.gov

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NCT06095089


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