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

Launched by DEBIOPHARM INTERNATIONAL SA · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Debio 4228 for men with advanced prostate cancer that has spread to other parts of the body. The main goal of the trial is to understand how the drug works in the body and its effects on cancer. If you are a man aged between 65 and 74 with confirmed prostate cancer and are considered a candidate for ongoing hormone therapy, you may be eligible to participate. Other important criteria include having certain testosterone levels and being in good overall health, with a life expectancy of at least six months.

If you decide to join the trial, you'll be closely monitored by researchers to see how well the treatment works and what side effects, if any, it may cause. The study is currently looking for participants, so it’s a great opportunity to potentially receive a new treatment while contributing to important research that could help others with similar conditions in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• 1. Participant with histologically confirmed diagnosis of prostate cancer, with one of the following:
• • 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:
• • 1. Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and \<6 months treatment-free interval before start of screening.
• • 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.
• • \[Note: Other protocol and subprotocol-defined criteria apply\]