Safety and Pharmacokinetics of ODM-209

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma

Criteria

MAIN INCLUSION CRITERIA:

• Written informed consent (IC) obtained.

• Age ≥ 18 years.

• ECOG performance status 0-1.

• Adequate marrow, liver and kidney function.

• Able to swallow study treatment.

Main Prostate cancer specific inclusion criteria:

• Histologically confirmed adenocarcinoma of the prostate.

• Castration resistant prostate cancer with serum testosterone < 50 ng/dl.

• Metastatic disease.

• Ongoing androgen deprivation therapy with GnRH analogue, or have had bilateral orchiectomy.

• Have had treatment with at least one line of second generation androgen receptor targeting therapy and one line of chemotherapy.

Main Breast cancer specific inclusion criteria:

• Histologically confirmed breast carcinoma

• ER positive, HER2-negative advanced breast cancer

• Postmenopausal or pre/perimenopausal if amendable to be treated with GnRH agonist or antagonist.

• Documented disease progression after treatment with at least 2 lines of systemic treatment for advanced breast cancer. Of these, at least one line must have been endocrine treatment in combination with a cdk4/6 inhibitor.

MAIN EXCLUSION CRITERIA

• History of pituitary dysfunction.

• Known brain metastases or active leptomeningeal disease.

• Active infection or other medical condition that would make corticosteroids contraindicated.

• Hypotension or uncontrolled hypertension.

• Clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past six months, unstable angina, or congestive heart failure (New York Heart Association [NYHA] class II-IV).

• Prolonged QTcF interval.

• Use of any investigational drug 4 weeks prior to the start of the study treatment.