Status:
RECRUITING
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
Lead Sponsor:
Phoenix Molecular Designs
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 breas...
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 ...
Eligibility Criteria
Inclusion
- 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):
- Prior chemotherapy
- ≤14 days from 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)
Exclusion
Key Trial Info
Start Date :
November 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04115306
Start Date
November 14 2019
End Date
October 1 2026
Last Update
November 20 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
City of Hope
Duarte, California, United States, 91010
3
City of Hope Orange County, Lennar
Irvine, California, United States, 92618
4
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095