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

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PMD-026 combined with a hormone-blocking drug (fulvestrant) in women with a type of metastatic breast cancer that is hormone receptor-positive (HR+), HER2-negative, and has a specific protein marker called RSK2. It targets cancers that have stopped responding to prior hormone therapies. **You may be eligible if...** - You have hormone receptor-positive, HER2-negative metastatic breast cancer - Your tumour tests positive for RSK2 - You have the normal ESR1 gene (not mutated) - Your cancer has progressed after a CDK4/6 inhibitor combined with endocrine therapy - You have received at least one prior hormone treatment for metastatic or locally advanced breast cancer - You have at least one measurable tumour - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have previously received chemotherapy for metastatic breast cancer - You have ESR1 gene mutations - Your cancer has spread to vital organs in a way that urgently requires chemotherapy - You have untreated or unstable brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPMD-026

Investigational Drug

DRUGfulvestrant

SERDs


Locations(11)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04115306


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