RecruitingPhase 2NCT06395753

A Dose Finding Study of Debio 4228 in Participants With Advanced Prostate Cancer

A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Advanced Prostate Cancer

Sponsor

Debiopharm International SA

Enrollment

66 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This dose-finding study tests a new experimental drug called Debio 4228 in men with advanced prostate cancer, particularly those whose cancer has stopped responding to hormone therapy (called castration-resistant prostate cancer). **You may be eligible if...** - You have been diagnosed with advanced prostate cancer - Your cancer has progressed despite hormone therapy (castration-resistant) - You are at least 18 years old with adequate organ function - You have not received an excessive number of prior treatment lines **You may NOT be eligible if...** - You have active brain metastases - You have serious heart conditions or significant QT interval prolongation on an ECG - You have uncontrolled infections or serious medical conditions - You are taking medications that strongly interact with the study drug 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

DRUGDebio 4228

Administered as IM injection.

Locations(37)

Valley Urology

Fresno, California, United States

East Valley Urology Center of Arizona

Queen Creek, Arizona, United States

Bakersfield Institute of Advanced Urology

Bakersfield, California, United States

Grimaldi Urology

Chula Vista, California, United States

Alarcon Urology Center

Montebello, California, United States

Urology Center of Southern California

Murrieta, California, United States

Pasadena Urological Medical Group

Pasadena, California, United States

AP Medical Research

Miami, Florida, United States

Urology Group of Southern California

Los Angeles, California, United States

Advanced Urology

Los Angeles, California, United States

Tower Urology,

Los Angeles, California, United States

Urologic Surgeons of Arizona

Mesa, Arizona, United States

First Urology- Jeffersonville

Jeffersonville, Indiana, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Oregon Urology Institut

Springfield, Oregon, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

GU Research Network/Wichita Urology Group

Wichita, Kansas, United States

Summit Cancer Centers of North Spokane

Spokane, Washington, United States

Instituto Valenciano de Oncologia

Valencia, Spain

AZ Groeninge

Kortrijk, Belgium

AZ Delta

Roeselare, Belgium

CHU Angers

Angers, France

CHRU de Brest - Hopital Morvan

Brest, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges Francois Leclerc

Dijon, France

CHU de Nantes - Hôtel Dieu

Nantes, France

Hospital Clinico San Carlos

Madroñera, Spain

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, Spain

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Biogenix Molecular

Miami, Florida, United States

AP-HP Hopital Pitie-Salpetriere

Paris, France

Urology Clinics of North Texas

Dallas, Texas, United States

Urology of Virginia

Virginia Beach, Virginia, United States

University Hospital Gent

Ghent, Belgium

Icahn School of Medicine at Mount Sinai

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06395753

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