A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic 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: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 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.

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