RecruitingPhase 1NCT05818683

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

300 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Hormone Sensitive Prostate Cancer Metastatic Castration-resistant Prostate Neoplasms

Summary

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests various combinations of a new drug called JNJ-78278343 with other established prostate cancer treatments for men with metastatic castration-resistant prostate cancer (mCRPC) — meaning their cancer has spread and continues to grow even after hormone therapy. The study aims to find the safest and most effective drug combination. **You may be eligible if...** - You have been diagnosed with metastatic prostate cancer that has stopped responding to standard hormone therapy - Your cancer has been confirmed by biopsy as adenocarcinoma - You meet organ function requirements (blood, liver, kidney tests within range) - You have tried at least one prior treatment for castration-resistant disease **You may NOT be eligible if...** - You have certain types of prostate cancer (neuroendocrine or small cell) - You have had prior treatment with specific drugs being tested in the relevant combination arm - You have serious heart, liver, or infection problems - You are unable to take oral medication 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

DRUGPasritamig

Pasritamig will be administered.

DRUGCetrelimab

Cetrelimab will be administered by intravenous infusion.

DRUGCabazitaxel

Cabazitaxel will be administered by intravenous infusion.

DRUGDocetaxel

Docetaxel will be administered by intravenous infusion.

DRUGApalutamide

Apalutamide will be administered orally.

DRUGEnzalutamide

Enzalutamide will be administered orally.

DRUGDarolutamide

Darolutamide will be administered orally.

DRUGAbiraterone acetate plus prednisone (AAP)

Abiraterone acetate plus prednisone (AAP) will be administered orally.

DRUGLutetium Lu-177 vipivotide tetraxetan

Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.

DRUGJNJ-101556143

JNJ-101556143 will be administered orally.

Locations(15)

Florida Cancer Specialists

Sarasota, Florida, United States

Start Midwest

Grand Rapids, Michigan, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Perlmutter Cancer Center at NYU Langone Brooklyn

Brooklyn, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

NYU Langone Health

New York, New York, United States

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, United States

Icon Cancer Centre Kurralta Park

Kurralta Park, Australia

Macquarie University

Macquarie University, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT05818683

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