Active — Not RecruitingPhase 2

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

United States66 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 range18 Years

SexMALE

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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.
✕. 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.

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 completion2026-12

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