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

Phase 1

Conditions: locally advanced/metastatic prostate cancer
MedDRA version: 21.1Level: PTClassification code: 10036909Term: Prostate cancer metastatic Class: 100000004864
Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-511038-11-00

Lead Sponsor: Debiopharm International SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 60

Inclusion Criteria

Participant with histologically confirmed locally advanced/metastatic prostate cancer, Participant judged by the Study Investigator to be candidate for continuous ADT, Baseline morning serum testosterone levels >150 ng/dL at screening visit, Age =18 years, 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, Other protocol and subprotocol defined criteria apply.

Exclusion Criteria

Previous ADT (neoadjuvant or adjuvant hormonal therapy) for =6 months duration and <6 months treatment-free interval before start of screening, Indication for androgen deprivation combination therapy, 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, Other protocol and subprotocol-defined criteria apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the PK/PD of Debio 4228;Secondary Objective: To evaluate the efficacy of Debio 4228 in achieving and maintaining castration, To evaluate the efficacy of Debio 4228 in terms of time to castration, To assess the local tolerability at the injection site, To assess injection site pain, To assess the safety profile of Debio 4228, To assess the serum prostate-specific antigen (PSA) level over time, To assess the change of serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels over time;Primary end point(s): Degarelix plasma PK profile and PK parameters over 12 weeks after Debio 4228 dosing, including but not limited to: - Maximum concentration (Cmax) - Area under the concentration-time curve over 12 weeks (AUC84d) - Concentration at 12 weeks (C84d) This will be derived for each treatment period., Testosterone serum concentration profile from Day 1 to Day 85 for all cohorts and from Day 85 to Day 169 in case of Cohort 3

Secondary Outcome Measures