A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
Principal Investigator
Alan L. Ho, MD, PhD,
Status
Open to Accrual
Date Opened To Accrual
September 30 2022
Disease Site
Head and Neck [HN]
Head and Neck
Phase
II
Developmental Therapeutics
No
Primary Objective
HER2-Positive Cohort: To determine if ado-trastuzumab emtansine (T-DM1) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment.
HER2-Low Expressing Cohort: To determine the overall response rate (ORR) by RECIST v1.1 criteria with DS-8201a (trastuzumab deruxtecan) in R/M HER2-low expressing SGC patients.
Patient Population
Pathologically(histologically or cytologically) proven diagnosis of HER2-positive OR HER2-lowexpressing recurrent/metastatic salivary gland cancer (SGC).
Pathologically proven diagnosis of HER2-positive SGC based on local site immunohistochemistry (IHC), fluorescent in-situ hybridization (FISH), or local/commercial next-generation sequencing (NGS) is required.
Target Accrual
146