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

Clinicaltrials.gov ID: NCT06395753

Status RECRUITING

Phase PHASE2

Age ≥ 18 Years

Enrollments 60

Conditions

Prostate Cancer

Drugs

Debio 4228

Summary

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

Locations

10 locations Found with status Recruiting

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

Status

RECRUITING

Central Contacts

Debiopharm International S.A
+41 21 321 01 11
[email protected]

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]

Study Plan

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.

DRUG:
Debio 4228
Description:
Administered as IM injection.

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
Description:
Administered as IM injection.

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
Description:
Administered as IM injection.

Outcome Measures

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of Debio 4228

Time Frame: 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)

Time Frame: 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)

Time Frame: Cohorts 1 and 2: Post-dose on Day 84; Cohort 3: Post-dose on Days 84 and 168

Serum Concentration of Testosterone

Time Frame: 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

Number of Participants who Achieved and Maintained a Testosterone Castration (Testosterone Level of <50 [Nanograms per Deciliter] ng/dL and <20 ng/dL)

Time Frame: 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)

Time Frame: Cohort 3: Days 29 to 169

Time to Achieve Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169

Timeline

Last Updated
October 29, 2024
Start Date
May 2, 2024
Today
January 22, 2025
Completion Date ( Estimated )
April 1, 2026

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

Conditions

Drugs

Summary

Locations

10 locations Found with status Recruiting

Tower Urology,

Biogenix Molecular

First Urology- Jeffersonville

GU Research Network/Wichita Urology Group

Associated Urologists of North Carolina

Oregon Urology Institut

Carolina Urologic Research Center

Urology Clinics of North Texas

Urology of Virginia

Summit Cancer Centers of North Spokane

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Status

Central Contacts

Eligibility Criteria

Study Plan

Cohort 1: Debio 4228 Dose Level 1

EXPERIMENTAL

DRUG:

Description:

Cohort 2: Debio 4228 Dose Level 2

EXPERIMENTAL

DRUG:

Description:

Cohort 3

EXPERIMENTAL

DRUG:

Description:

Outcome Measures

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of Debio 4228

Area Under the Concentration-time Curve of Debio 4228 Over 12 weeks (AUC84d)

Plasma Concentration of Debio 4228 at Week 12 (C84d)

Serum Concentration of Testosterone

Secondary Outcome Measures

Number of Participants who Achieved and Maintained a Testosterone Castration (Testosterone Level of <50 [Nanograms per Deciliter] ng/dL and <20 ng/dL)

Number of Participants who Maintained a Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)

Time to Achieve Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)

Number of Participants who Experience Local Reactions Categorized as Erythema, Swelling, and Induration at the Injection Site

Number of Participants who Experience Pain at Injection Site

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity

Number of Participants With Related TEAEs, Serious TEAEs, Adverse Events of Special Interest (AESIs), TEAEs Leading to Treatment Delay, and/or Discontinuation, and Death

Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, and Electrocardiogram (ECG) Parameters

Percent Change From Baseline in Serum Prostate-Specific Antigen (PSA) Over Time

Change From Baseline of Serum Luteinizing Hormone (LH) Over Time

Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Over Time

Timeline

Last Updated

Start Date

Today

Completion Date ( Estimated )

Sponsors of this trial

Lead Sponsor

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