Ph 1/1b/2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer
Phoenix Molecular Designs
Summary
The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.
Description
Combination with fulvestrant (Part 3): This study will enroll RSK2+, HR+, and human epidermal growth factor receptor 2 negative (HER2-) patients to evaluate PMD-026 in combination with a standard dose and schedule of fulvestrant. Fulvestrant will be dosed per the package insert in combination with PMD-026 at the RP2D determined in the monotherapy phase of the study. Up to 20 patients will be enrolled with locally advanced or metastatic HR+/HER2- breast cancer previously treated with a CDK4/6 inhibitor in combination with endocrine therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria, Combination with fulvestrant (Part 3): * RSK2 positive from available archival or fresh tumor tissue (FFPE). * Histologically or cytologically diagnosed HR+, HER2- * ESR1 wild type * Diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy * Must be appropriate candidates for endocrine therapy * Previously received at least 1 line of endocrine therapy for MBC or had recurrence while on adjuvant endocrine therapy for locally…
Interventions
- DrugPMD-026
Investigational Drug
- Drugfulvestrant
SERDs
Locations (11)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- City of HopeDuarte, California
- City of Hope Orange County, LennarIrvine, California
- University of California, Los Angeles (UCLA)Los Angeles, California
- Moffitt Cancer CenterTampa, Florida
- City of Hope ChicagoZion, Illinois