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Completed
NCT06395753
A Dose Finding Study of Debio 4228 in Participants With Advanced Prostate Cancer
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 55
Sponsor: Debiopharm International SA
Location: Urologic Surgeons of Arizona Mesa Arizona
Summary
The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.
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 \
Source: ClinicalTrials.gov (NCT06395753). StuddyBuddy aggregates publicly available trial information.
