NRG-HN010

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

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-low
expressing 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