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

NCT06395753 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: Debio 4228-201U1111-1298-89432024-511038-11
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 26

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• 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

Study Arms (3)

Cohort 1: Debio 4228 Dose Level 1

EXPERIMENTAL

Participants will receive a single intramuscular (IM) administration of dose level 1 Debio 4228 on Day 1. Enrolment for cohort 1 was discontinued as per protocol amendment v5.0

Drug: Debio 4228

Cohort 2: Debio 4228 Dose Level 2

EXPERIMENTAL

Participants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.

Drug: Debio 4228

Cohort 3

EXPERIMENTAL

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).

Drug: Debio 4228

Interventions

Debio 4228 DRUG

Administered as IM injection.

Cohort 1: Debio 4228 Dose Level 1; Cohort 2: Debio 4228 Dose Level 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with advanced prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \[Note: Other protocol and subprotocol-defined criteria apply\]

You may not qualify if:

• 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.
• \[Note: Other protocol and subprotocol-defined criteria apply\]

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (26)

Urologic Surgeons of Arizona

Mesa, Arizona, 85206, United States

Location

East Valley Urology Center of Arizona

Queen Creek, Arizona, 85140, United States

Location

Bakersfield Institute of Advanced Urology

Bakersfield, California, 93301, United States

Location

Grimaldi Urology

Chula Vista, California, 91910, United States

Location

Valley Urology

Fresno, California, 93722, United States

Location

Tower Urology,

Los Angeles, California, 90048, United States

Location

Alarcon Urology Center

Montebello, California, 90640, United States

Location

Urology Center of Southern California

Murrieta, California, 92563, United States

Location

AP Medical Research

Miami, Florida, 33165, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Oregon Urology Institut

Springfield, Oregon, 97477, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Summit Cancer Centers of North Spokane

Spokane, Washington, 99208, United States

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

CHU Angers

Angers, 49933, France

Location

CHRU de Brest - Hopital Morvan

Brest, 29200, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Georges Francois Leclerc

Dijon, 21000, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44093, France

Location

AP-HP Hopital Pitie-Salpetriere

Paris, 75013, France

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, 8036, Spain

Location

Hospital Clinico San Carlos

Madroñera, 28040, Spain

Location

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, 08208, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); ES (5); FR (6); US (14)