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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT06395753

Run by

Debiopharm International SA

People needed

55

Starts

2024-05-23

Expected to finish

2026-07-22

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Participant with histologically confirmed diagnosis of prostate cancer, with one of the following:
• Newly diagnosed androgen-sensitive locally advanced or metastatic disease; or
• Localized disease not suitable for local primary intervention with curative intent.
• Participant judged by the Study Investigator to be candidate for continuous androgen deprivation therapy (ADT).
• Baseline morning serum testosterone levels >150 ng/dL at screening visit.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Life expectancy of at least 6 months.
• Adequate bone marrow, hepatic, and renal function at the screening visit.
• [Note: Other protocol and subprotocol-defined criteria apply]

You may not qualify if…

• Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and <6 months treatment-free interval before start of screening.
• Participant requires combination with androgen deprivation therapy with the exception of enzalutamide.
• History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
• Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer.
• Abnormal cardiovascular function or diabetes.
• Use of exogenous testosterone within 6 months before the start of screening.
• Major surgery within 4 weeks before the start of screening.
• Cancer disease within the last two years except for prostate cancer and some skin cancers.
• [Note: Other protocol and subprotocol-defined criteria apply]

Where it is running

• 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
• Tower Urology, — Los Angeles, California, United States
• Alarcon Urology Center — Montebello, California, United States
• Urology Center of Southern California — Murrieta, California, United States
• Biogenix Molecular — Miami, Florida, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Oregon Urology Institut — Springfield, Oregon, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology of Virginia — Virginia Beach, Virginia, United States
• Summit Cancer Centers of North Spokane — Spokane, Washington, United States
• Centre Jean Perrin — Clermont-Ferrand, France
• Centre Georges Francois Leclerc — Dijon, France
• CHU de Nantes - Hôtel Dieu — Nantes, France
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital Clinic Barcelona — Barcelona, Spain
• Hospital Clinico San Carlos — Madroñera, Spain
• Instituto Valenciano de Oncologia — Valencia, Spain

Full record on ClinicalTrials.gov

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