Trial Title:
A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer
NCT ID:
NCT06395753
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Debio 4228
Description:
Administered as IM injection.
Arm group label:
Cohort 1: Debio 4228 Dose Level 1
Arm group label:
Cohort 2: Debio 4228 Dose Level 2
Arm group label:
Cohort 3
Summary:
The primary purpose of this study is to determine the pharmacokinetics (PK) and
pharmacodynamics (PD) of Debio 4228.
Criteria for eligibility:
Criteria:
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]
Gender:
Male
Gender based:
Yes
Gender description:
Males with locally advanced/metastatic prostate cancer.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tower Urology,
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Facility:
Name:
Biogenix Molecular
Address:
City:
Miami
Zip:
33165
Country:
United States
Status:
Recruiting
Facility:
Name:
First Urology- Jeffersonville
Address:
City:
Jeffersonville
Zip:
47130
Country:
United States
Status:
Recruiting
Facility:
Name:
GU Research Network/Wichita Urology Group
Address:
City:
Wichita
Zip:
67226
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
Shirley
Zip:
11697
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Associated Urologists of North Carolina
Address:
City:
Raleigh
Zip:
27612
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Urology Institut
Address:
City:
Springfield
Zip:
97477
Country:
United States
Status:
Recruiting
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology Clinics of North Texas
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology of Virginia
Address:
City:
Virginia Beach
Zip:
23462
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Cancer Centers of North Spokane
Address:
City:
Spokane
Zip:
99208
Country:
United States
Status:
Recruiting
Facility:
Name:
AZ Groeninge
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHU de Nantes - Hôtel Dieu
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madroñera
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Address:
City:
Sabadell
Zip:
08208
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Instituto Valenciano de Oncologia
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Not yet recruiting
Start date:
May 23, 2024
Completion date:
April 2026
Lead sponsor:
Agency:
Debiopharm International SA
Agency class:
Industry
Source:
Debiopharm International SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06395753
