Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
Purpose
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.
Condition
- Metastatic Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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- - 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 advanced breast cancer - Discontinued endocrine therapy at least 15 days prior to first dose of PMD-026 - At least 1 measurable target lesion as defined by RECIST v1.1 - Progression on or after treatment with a CDK4/6 inhibitor in combination with endocrine therapy inhibitor in the locally advanced or metastatic setting - Adequate hematologic, hepatic, and renal function as assessed by laboratory parameters - Toxicity related to prior therapy resolved to at least Grade 1 (alopecia excepted) or to at least Grade 2 with prior approval of the Medical Monitor
Exclusion Criteria
, Combination with fulvestrant (Part 3): - ≤14 days from prior chemotherapy, biological or investigational therapy - Prior fulvestrant in the locally advanced or metastatic setting - Presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated - Central nervous system metastases, unless appropriately treated and neurologically stable - History of leptomeningeal metastases - Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy - Known hepatitis B or hepatitis C infection - Known HIV-positive with CD4+ cell counts <350 cells/μL - Known HIV-positive with a history of an AIDS-defining opportunistic infection - History of clinically significant cardiovascular abnormalities, including QTcF interval >460 msec (using Fridericia's formula)
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Oral PMD-026 in combination with fulvestrant |
Daily dosing of PMD-026 with fulvestrant dosing according to package insert |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Phoenix Molecular Designs
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.