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Prostate CancerPhase 2NCT06395753

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

A Phase 2 study testing Debio 4228 in people with Prostate Cancer, run by Debiopharm International SA at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Debio 4228
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
21 sitesin 3 countries
Study dates
23 May 2024to 22 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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]

Who cannot join

  • 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.
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  • 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]

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

United States14 sites

  • Bakersfield Institute of Advanced Urology

    Bakersfield, California, 93301

  • Grimaldi Urology

    Chula Vista, California, 91910

  • Valley Urology

    Fresno, California, 93722

  • Tower Urology,

    Los Angeles, California, 90048

  • Urologic Surgeons of Arizona

    Mesa, Arizona, 85206

  • Biogenix Molecular

    Miami, Florida, 33165

  • Alarcon Urology Center

    Montebello, California, 90640

  • Urology Center of Southern California

    Murrieta, California, 92563

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • East Valley Urology Center of Arizona

    Queen Creek, Arizona, 85140

  • Summit Cancer Centers of North Spokane

    Spokane, Washington, 99208

  • Oregon Urology Institut

    Springfield, Oregon, 97477

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

Other trials in United States

Spain4 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 8036

  • Hospital Clinico San Carlos

    Madroñera, 28040

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

France3 sites

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

Other trials in France

About this study

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 Advanced Prostate Cancer

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

Conditions
Prostate Cancer
Being tested
Debio 4228
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Debio 4228Drug

    Administered as IM injection.

Study groups in NCT06395753
Study groupRoleWhat they receive
Cohort 1: Debio 4228 Dose Level 1ExperimentalParticipants 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
Receives: Drug: Debio 4228
Cohort 2: Debio 4228 Dose Level 2ExperimentalParticipants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.
Receives: Drug: Debio 4228
Cohort 3ExperimentalIf 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).
Receives: Drug: Debio 4228

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration (Cmax) of Debio 4228

    Measured: 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

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

    Measured: 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

  3. Plasma Concentration of Debio 4228 at Week 12 (C84d)

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

  4. Serum Concentration of Testosterone

    Measured: 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)

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

    Measured: Cohorts 1, 2, and 3: Days 29 to 85

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

    Measured: Cohort 3: Days 29 to 169

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

    Measured: Cohorts 1 and 2: Day 1 up to Day 85; Cohort 3: Day 1 up to Day 169

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

    Measured: 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

  5. Number of Participants who Experience Pain at Injection Site

    Measured: 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

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

    Measured: Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197

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

    Measured: Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197

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

    Measured: Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start23 May 2024
  3. Primary completion24 Jun 2026
  4. Study completion22 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395753
Sponsor's protocol ID
Debio 4228-201
Other IDs
U1111-1298-8943, 2024-511038-11
Status last verified
Aug 2026
First submitted
29 Apr 2024
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Debio 4228 in people with Prostate Cancer, run by Debiopharm International SA at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06395753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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