Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer

The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

Inclusion Criteria

• Progressive metastatic or locally advanced or metastatic breast cancer.
• Clinically confirmed as postmenopausal.
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 at screening.

Exclusion Criteria

• HER2 positive patients by local laboratory testing.
• Triple negative breast cancer.
• Any chemotherapy within the 28 days prior to the first dose of study drug.
• Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.
• Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.
• Fulvestrant within 30 days prior to first dose of study drug.
• Any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter.
• Radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study.
• Known history of human immunodeficiency virus infection (HIV) or hepatitis C or active hepatitis B infection, unless the patient was diagnosed >10 years prior to enrollment and no evidence of active liver disease.
• Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.
• Untreated or uncontrolled brain metastasis.
• Diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin.
• Pregnant and nursing females.

This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

Lead Organization
Radius Pharmaceuticals, Inc.

Primary ID RAD140-01-001
Secondary IDs NCI-2017-01503
Clinicaltrials.gov ID NCT03088527