Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
NCT04620187 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2026-04-13
Summary
This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.
Conditions
- Salivary Gland Cancer
- HER2 Gene Mutation
Interventions
- DRUG
-
Ado-trastuzumab (T) emtansine (T-DM1)
Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)
- RADIATION
-
Standard of Care Radiotherapy
Radiotherapy to shrink or kill tumors
- DRUG
-
Standard of Care Chemotherapy
Intravenous injection
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Glenn J Hanna, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-24
- Primary Completion
- 2028-02-01
- Completion
- 2029-02-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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