Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
NCT ID: NCT04115306
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2019-11-14
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oral PMD-026 in combination with fulvestrant
Daily dosing of PMD-026 with fulvestrant dosing according to package insert
PMD-026
Investigational Drug
fulvestrant
SERDs
Interventions
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PMD-026
Investigational Drug
fulvestrant
SERDs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* ≤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)
18 Years
ALL
No
Sponsors
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Phoenix Molecular Designs
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
City of Hope Orange County, Lennar
Irvine, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
City of Hope Chicago
Zion, Illinois, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Profound Research
Farmington Hills, Michigan, United States
Ohio State University
Columbus, Ohio, United States
Oncology Consultants
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Nibu Mathew
Role: primary
Stephanie Hernandez, CRC
Role: backup
Felicia Lewis
Role: primary
Ankita Singh
Role: primary
Monica Rocha
Role: primary
Neveen Abdo
Role: primary
Heather Johansen
Role: primary
Natalie Moffett
Role: primary
Heather Austin
Role: primary
Role: backup
Emily Viall, RN
Role: primary
Robert Wesolowski, MD
Role: backup
Isabel Jimenez, RN, MSN
Role: primary
Other Identifiers
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PMD-026-1-001
Identifier Type: -
Identifier Source: org_study_id