A Dose Finding Study of Debio 4228 in Participants With Advanced Prostate Cancer
NCT ID: NCT06395753
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2024-05-23
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: Debio 4228 Dose Level 1
Participants will receive a single intramuscular (IM) administration of dose level 1 Debio 4228 on Day 1. Enrolment for cohort 1 was discontinued as per protocol amendment v5.0
Debio 4228
Administered as IM injection.
Cohort 2: Debio 4228 Dose Level 2
Participants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.
Debio 4228
Administered as IM injection.
Cohort 3
If any alternative dose is deemed necessary based on preliminary data, participants may be enrolled in Cohort 3 to receive Debio 4228 loading dose IM, on Day 1 followed by a maintenance dose IM, 12 weeks after receiving the loading dose (Day 85).
Debio 4228
Administered as IM injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Debio 4228
Administered as IM injection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Newly diagnosed androgen-sensitive locally advanced or metastatic disease; or
2. Localized disease not suitable for local primary intervention with curative intent.
2. Participant judged by the Study Investigator to be candidate for continuous androgen deprivation therapy (ADT).
3. Baseline morning serum testosterone levels \>150 ng/dL at screening visit.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
5. Life expectancy of at least 6 months.
6. Adequate bone marrow, hepatic, and renal function at the screening visit.
\[Note: Other protocol and subprotocol-defined criteria apply\]
Exclusion Criteria
2. Participant requires combination with androgen deprivation therapy with the exception of enzalutamide.
3. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
4. Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer.
5. Abnormal cardiovascular function or diabetes.
6. Use of exogenous testosterone within 6 months before the start of screening.
7. Major surgery within 4 weeks before the start of screening.
8. Cancer disease within the last two years except for prostate cancer and some skin cancers.
\[Note: Other protocol and subprotocol-defined criteria apply\]
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Debiopharm International SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Urologic Surgeons of Arizona
Mesa, Arizona, 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
Valley Urology
Fresno, California, 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
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
Biogenix Molecular
Miami, Florida, United States
First Urology- Jeffersonville
Jeffersonville, Indiana, United States
GU Research Network/Wichita Urology Group
Wichita, Kansas, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
New York Cancer and Blood Specialists
Shirley, New York, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Oregon Urology Institut
Springfield, Oregon, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Summit Cancer Centers of North Spokane
Spokane, Washington, United States
University Hospital Gent
Ghent, , Belgium
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
AP-HP Hopital Pitie-Salpetriere
Paris, , France
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Clinico San Carlos
Madroñera, , Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Sabadell, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1298-8943
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511038-11
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 4228-201
Identifier Type: -
Identifier Source: org_study_id