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

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Debio 4228

• Registration Number: NCT06395753
• Lead Sponsor: Debiopharm International SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Study Start: 2024-05-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Participant with histologically confirmed locally advanced/metastatic prostate cancer
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. Indication for androgen deprivation combination therapy
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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Debio 4228 Dose Level 1	Debio 4228	Participants will receive a single intramuscular (IM) administration of dose level 1 Debio 4228 on Day 1.
Cohort 3	Debio 4228	If any alternative dose is deemed necessary based on preliminary data, participants may be enrolled in Cohort 3 to receive Debio 4228 loading dose IM, on Day 1 followed by a maintenance dose IM, 12 weeks after receiving the loading dose (Day 85).
Cohort 2: Debio 4228 Dose Level 2	Debio 4228	Participants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Debio 4228	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)	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)	Cohorts 1 and 2: Post-dose on Day 84; Cohort 3: Post-dose on Days 84 and 168
Serum Concentration of Testosterone	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants who Achieved and Maintained a Testosterone Castration (Testosterone Level of <50 [Nanograms per Deciliter] ng/dL and <20 ng/dL)	Cohorts 1, 2, and 3: Days 29 to 85
Number of Participants who Maintained a Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)	Cohort 3: Days 29 to 169
Time to Achieve Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)	Cohorts 1 and 2: Day 1 up to Day 85; Cohort 3: Day 1 up to Day 169
Number of Participants who Experience Local Reactions Categorized as Erythema, Swelling, and Induration at the Injection Site	Cohorts 1 and 2: Immediately, at 2 and 24 hours post-injection on Day 1; Cohort 3: Immediately, at 2 and 24 hours post-injection on Days 1 and 85
Number of Participants who Experience Pain at Injection Site	Cohorts 1 and 2: Immediately, at 2 and 24 hours post-injection on Day 1; Cohort 3: Immediately, at 2 and 24 hours post-injection on Days 1 and 85
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity	Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197
Number of Participants With Related TEAEs, Serious TEAEs, Adverse Events of Special Interest (AESIs), TEAEs Leading to Treatment Delay, and/or Discontinuation, and Death	Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197
Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, and Electrocardiogram (ECG) Parameters	Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197
Percent Change From Baseline in Serum Prostate-Specific Antigen (PSA) Over Time	Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169
Change From Baseline of Serum Luteinizing Hormone (LH) Over Time	Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169
Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Over Time	Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169

Trial Locations

Locations (23)

Biogenix Molecular; 🇺🇸 Miami, Florida, United States

University Hospital Gent; 🇧🇪 Gent, Belgium

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell; 🇪🇸 Sabadell, Spain

Instituto Valenciano de Oncologia; 🇪🇸 Valencia, Spain

Bakersfield Institute of Advanced Urology; 🇺🇸 Bakersfield, California, United States

Tower Urology,; 🇺🇸 Los Angeles, California, United States

Urology Center of Southern California; 🇺🇸 Murrieta, California, United States

AP Medical Research; 🇺🇸 Miami, Florida, United States

First Urology- Jeffersonville; 🇺🇸 Jeffersonville, Indiana, United States

GU Research Network/Wichita Urology Group; 🇺🇸 Wichita, Kansas, United States

New York Cancer and Blood Specialists; 🇺🇸 Shirley, New York, United States

Associated Urologists of North Carolina; 🇺🇸 Raleigh, North Carolina, United States

Oregon Urology Institut; 🇺🇸 Springfield, Oregon, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Urology Clinics of North Texas; 🇺🇸 Dallas, Texas, United States

Urology of Virginia; 🇺🇸 Virginia Beach, Virginia, United States

Summit Cancer Centers of North Spokane; 🇺🇸 Spokane, Washington, United States

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madroñera, Spain