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

Prostate Cancer Clinical Trial

Official title:

A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Locally Advanced/Metastatic Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395753
• Other study ID #: Debio 4228-201
• Secondary ID: U1111-1298-89432
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Debiopharm International SA
• Contact: Debiopharm International S.A
• Phone: +41 21 321 01 11
• Email: clinicaltrials[@]debiopharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Debio 4228
Administered as IM injection.

Locations

Country	Name	City	State
United States	First Urology- Jeffersonville	Jeffersonville	Indiana
United States	Tower Urology,	Los Angeles	California
United States	Biogenix Molecular	Miami	Florida
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Associated Urologists of North Carolina	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 197
Primary	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 168
Primary	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
Primary	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	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
Secondary	Number of Participants who Maintained a Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)		Cohort 3: Days 29 to 169
Secondary	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
Secondary	Number of Participants who Experience Local Reactions Categorized as Erythema, Swelling, and Induration at the Injection Site		Cohorts 1 and 2: Immediately and at 2 hours post-injection on Day 1; Cohort 3: Immediately and at 2 hours post-injection on Days 1 and 85
Secondary	Number of Participants who Experience Pain at Injection Site		Cohorts 1 and 2: Immediately and at 2 hours post-injection on Day 1; Cohort 3: Immediately and at 2 hours post-injection on Days 1 and 85
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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