Active — Not RecruitingPhase 2

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

United States, France, Spain55 participantsStarted 2024-05-23

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Plasma Concentration (Cmax) of Debio 4228

Timeframe: Cohorts 1 and 2: Predose and at multiple time points post-dose up to Day 169; Cohort 3: Predose and at multiple time points post-dose up to Day 169

Area Under the Concentration-time Curve of Debio 4228 Over 12 weeks (AUC84d)

Timeframe: Cohorts 1 and 2: Predose and at multiple time points post-dose up to Day 84; Cohort 3: Predose and at multiple time points post-dose up to Day 169

Plasma Concentration of Debio 4228 at Week 12 (C84d)

Timeframe: Cohorts 1 and 2: Post-dose on Day 84; Cohort 3: Post-dose on Days 84 and 168

Serum Concentration of Testosterone

Timeframe: Cohorts 1 and 2: Predose and at multiple time points post-dose from Days 1 to 85; Cohort 3: Predose and at multiple time points post-dose from Days 1 to 169

Trial details

NCT IDNCT06395753

SponsorDebiopharm International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

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