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

Debiopharm

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Debio 4228

Study type: Interventional

Funder types: Industry

Identifiers

NCT06395753

U1111-1298-8943 (Other Identifier)

2024-511038-11 (Other Identifier)

Debio 4228-201

Details and patient eligibility

About

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

Enrollment: 66 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Cohort 1: Debio 4228 Dose Level 1

Experimental group

Description:

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

Treatment:

Drug: Debio 4228

Cohort 2: Debio 4228 Dose Level 2

Experimental group

Description:

Participants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.

Treatment:

Drug: Debio 4228

Cohort 3

Experimental group

Description:

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).

Treatment:

Drug: Debio 4228