Phase 1/1b Study of Oral PMD-026 in Patients With Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Phoenix Molecular Designs
Updated on 28 May 2022
cancer
measurable disease
breast cancer
gilbert's syndrome
neutrophil count
tumor cells
HER2
alopecia
triple negative breast cancer
stage iv breast cancer
erbb2
formalin-fixed paraffin-embedded

Summary

The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer and triple negative breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer and triple negative breast cancer.

Description

This study will evaluate the safety and tolerability of PMD-026 using an accelerated titration design to define the MTD in metastatic breast cancer, followed by an expansion at the RP2D in triple negative breast cancer. All patients will receive daily oral doses of PMD-026 until either disease progression or unacceptable toxicity. Patients will have disease assessments initially after 6 weeks of treatment, and every 9 weeks thereafter.

Patients enrolled to the Dose Escalation Phase must have histologically or cytologically diagnosed metastatic breast cancer that has progressed on or after standard of care therapy. Patients enrolled to the Dose Expansion Phase must have histologically or cytologically diagnosed metastatic triple negative breast cancer from initial diagnosis (ER/PgR <1%, HER2 negative) that has progressed on or after standard of care therapy. All patients must provide tumor tissue (archival preferred) prior to study entry.

A subset (N=12) of patients in Part 2 of the study will participate in a 1- week evaluation of the effect of food on PMD-026 oral absorption.

PMD-026 is an oral, reversible small molecule inhibitor of RSK1-4 with high selectivity for RSK2. High levels of RSK2 expression have been associated with worse overall survival in breast cancer. Inhibiting RSK2 may inhibit growth of breast cancer.

Details
Condition Metastatic Breast Cancer, Triple Negative Breast Cancer
Treatment PMD-026
Clinical Study IdentifierNCT04115306
SponsorPhoenix Molecular Designs
Last Modified on28 May 2022

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