Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
Sponsor: Phoenix Molecular Designs
ClinicalTrials ID:NCT04115306
This study evaluates the safety of PMD-026 with fulvestrant in RSK2+ HR+/HER2- metastatic breast cancer patients. Up to 20 patients, previously treated with CDK4/6 inhibitors, will receive PMD-026 (200 mg, PO, Q12h) and fulvestrant (500 mg IM) per standard dosing. A safety lead-in cohort of 6 patients will be assessed before expanding to 20, using a Bayesian safety monitoring rule for DLTs.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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 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.
Eligibility Criteria
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)
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| University of California, Los Angeles (UCLA) | 90095 | Los Angeles | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Massachusetts General Hospital | 02215 | Boston | Massachusetts |
| Profound Research | 48334 | Farmington Hills | Michigan |
| Ohio State University | 43210 | Columbus | Ohio |
| Oncology Consultants | 77030 | Houston | Texas |
| South Texas Accelerated Research Therapeutics | 78229 | San Antonio | Texas |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.