A Dose Finding Study of Debio 4228 in Participants With Advanced 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: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-22
• Primary Completion: 2026-12
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

1. Participant with histologically confirmed diagnosis of prostate cancer, with one of the following:

   1. Newly diagnosed androgen-sensitive locally advanced or metastatic disease; or
   2. Localized disease not suitable for local primary intervention with curative intent.

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. Participant requires combination with androgen deprivation therapy with the exception of enzalutamide.
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. Enrolment for cohort 1 was discontinued as per protocol amendment v5.0
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.
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).

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 (27)

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

Valley Urology; 🇺🇸 Fresno, California, United States

Advanced Urology; 🇺🇸 Los Angeles, 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

Biogenix Molecular; 🇺🇸 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

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