Actively Recruiting
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
Led by Phoenix Molecular Designs · Updated on 2026-01-21
61
Participants Needed
11
Research Sites
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- RSK2 positive from available tumor tissue
- Diagnosed HR+ and HER2- breast adenocarcinoma
- ESR1 wild type
- Locally advanced or metastatic breast cancer not suitable for curative therapy
- Appropriate candidates for endocrine therapy
- Previously received at least 1 line of endocrine therapy for metastatic breast cancer or recurrence during adjuvant endocrine therapy
- Endocrine therapy stopped at least 15 days before starting PMD-026
- At least 1 measurable target lesion by RECIST v1.1
- Disease progression on or after CDK4/6 inhibitor with endocrine therapy
- Adequate blood, liver, and kidney function
- Side effects from prior therapy resolved to Grade 1 or Grade 2 with medical approval
You will not qualify if you...
- Prior chemotherapy
- ESR1 mutations
- Less than 14 days since last biological or investigational therapy
- Visceral crisis or uncontrolled visceral disease needing chemotherapy
- Untreated or unstable central nervous system metastases
- History of leptomeningeal metastases
- Active uncontrolled infections requiring systemic treatment
- Known hepatitis B or C infection
- Known HIV positive with CD4+ count below 350 cells/μL
- Known HIV positive with history of AIDS-defining infections
- Significant heart problems including QTcF interval over 460 msec
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope Orange County, Lennar
Irvine, California, United States, 92618
Actively Recruiting
4
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
City of Hope Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
7
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Profound Research
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
9
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Oncology Consultants
Houston, Texas, United States, 77030
Withdrawn
11
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
P
Phoenix Molecular Designs PMD
CONTACT
J
Joseph Leveque, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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