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

Study Identifier:
PMD-026-1-001
CT.gov Identifier:
NCT04115306
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

To evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with metastatic or locally advanced (inoperable) RSK2+ breast cancer.

Tumor tissue is assessed to retrospectively correlate RSK2 activity by immunohistochemistry (IHC) with clinical outcomes. Pharmacokinetics are assessed along with a food effect (sub-study with n=12). In addition, a pharmacodynamic marker, YB-1 phosphorylation, is being explored in peripheral blood mononuclear cells before and during treatment.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Oral PMD-026 in combination with fulvestrant Daily dosing of PMD-026 with fulvestrant dosing according to package insert Intervention: Drug: PMD-026 Investigational Drug Drug: fulvestrant SERDs
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion Criteria, Combination with fulvestrant (Part 3):
    • 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 criteria
    • Exclusion Criteria, Combination with fulvestrant (Part 3):
    • 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)

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Muralidhar Beeram
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers