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Clinical Trial Summary

This study is testing if the recommended dose of BTX-A51 is safe and tolerable in participants with liposarcoma. The name of the study drug used in this research study is: -BTX-A51 (a type of kinase inhibitor)


Clinical Trial Description

This is a single arm, pilot study assessing the safety and preliminary exploration of BTX-A51 in participants with metastatic and/or recurrent liposarcomas characterized by Murine Double Minute Clone 2 (MDM2) amplifications. BTX-A51 works in a different way from currently approved therapies used to treat liposarcoma by blocking proteins called CK1α and CDK9. The U.S. Food and Drug Administration (FDA) has not approved BTX-A51 as a treatment for Liposarcoma. The research study procedures include screening for eligibility, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomography (PET) scans, blood tests, and tumor biopsies. Participants will receive study treatment for as long as there are no serious side effects, and disease does not get worse. Participants will be followed for 1 year after the last dose of BTX-A51. It is expected that about 12 people will take part in this research study. Edgewood Oncology is supporting this research study by providing the study drug. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06414434
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Michael Wagner, MD
Phone 617-632-5204
Email MICHAEL_WAGNER@DFCI.HARVARD.EDU
Status Not yet recruiting
Phase Phase 1
Start date November 2024
Completion date June 1, 2027

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