Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
- Registration Number
- NCT04115306
- Lead Sponsor
- Phoenix Molecular Designs
- Brief 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.
- Detailed Description
Combination with fulvestrant (Part 3):
This study will prospectively 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oral PMD-026 in combination with fulvestrant fulvestrant Daily dosing of PMD-026 with fulvestrant dosing according to package insert Oral PMD-026 in combination with fulvestrant PMD-026 Daily dosing of PMD-026 with fulvestrant dosing according to package insert
- Primary Outcome Measures
Name Time Method Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+/HER2- previously treated breast cancer 6 weeks Incidence of AEs, DLTs, SAEs. Changes in laboratory, vital signs, and ECG values.
- Secondary Outcome Measures
Name Time Method Plasma concentration of PMD-026 when administered in combination with fulvestrant As determined by PK data The plasma concentration will be measured as part of pharmacokinetic (PK) testing.
Preliminary anti-tumor activity of PMD-026 when dosed in combination with fulvestrant Until PD or death, up to 2 years ORR, DOR, DCR, PFS
Trial Locations
- Locations (8)
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Profound Research
🇺🇸Farmington Hills, Michigan, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States