42
Participants
Start Date
November 1, 2025
Primary Completion Date
November 1, 2030
Study Completion Date
November 1, 2032
Asciminib and Trastuzumab
Each study treatment cycle will last 21 days. Asciminib will be taken orally every day during the treatment period at the dose determined as the MTD during the safety lead-in in combination with trastuzumab at a standard dose of 6mg/kg IV. Asciminib dose will begin at 80 mg daily (dose level 1), with a potential range from 40 mg daily (dose level -1A, with trastuzumab) to 200 mg bid (dose level 3, with trastuzumab) depending on the results of the safety lead-in. Trastuzumab will be given intravenously (IV) or subcutaneously (SQ) on Day 1 of each 21 day cycle.
Lead Sponsor
Collaborators (1)
Novartis
INDUSTRY
Duke University
OTHER