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

Sponsor: Debiopharm International SA

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06395753

Patient View

This study evaluates the pharmacokinetics and pharmacodynamics of Debio 4228, administered via IM injection, in participants with locally advanced/metastatic prostate cancer. Eligible participants must have confirmed cancer, be candidates for continuous ADT, have specific testosterone levels, an ECOG status of 0-2, a life expectancy of at least 6 months, and adequate organ function.

Patient Parameters

Program Overview

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

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]

Get This Program In Your Inbox

You can sign up and apply your patients for this program.