Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
a study on Breast Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Los Angeles 5368361, California 5332921 and other locations
- Dates
- study startedstudy ends around
Description
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.
Official Title
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
Details
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.
Keywords
Metastatic Breast Cancer, invasive breast cancer, PR-negative breast cancer, HER2-negative breast cancer, Breast cancer, Breast malignancy, breast malignancies, advanced breast cancer, solid tumor, late stage breast cancer/late-stage breast cancer, Breast Neoplasms, Fulvestrant, PMD-026
Eligibility
You can join if…
Open to people ages 18 years and up
, 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
You CAN'T join if...
, 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
- University of California, Los Angeles (UCLA)
accepting new patients
Los Angeles 5368361 California 5332921 90095 United States - Banner MD Anderson Cancer Center
accepting new patients
Gilbert 5295903 Arizona 5551752 85234 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Phoenix Molecular Designs
- Links
- Sign up for this study
- ID
- NCT04115306
- Phase
- Phase 1/2 Breast Cancer Research Study
- Study Type
- Interventional
- Participants
- Expecting 61 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.