RecruitingPhase 1Phase 2NCT04115306
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
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
Sponsor
Phoenix Molecular Designs
Enrollment
61 participants
Start Date
Nov 14, 2019
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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 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 Criteria11
- Prior chemotherapy
- ESR1 mutations
- ≤14 days from biological or investigational therapy
- 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)
Interventions
DRUGPMD-026
Investigational Drug
DRUGfulvestrant
SERDs
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04115306
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