RecruitingPhase 2NCT05673928
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
Sponsor
M.D. Anderson Cancer Center
Enrollment
30 participants
Start Date
May 16, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study tests the combination of tucatinib (a targeted HER2 therapy) and T-DM1 (an antibody-drug that delivers chemotherapy directly to HER2-positive tumor cells) in patients with HER2-positive cancers that have spread to the brain. HER2-positive means the tumor has an excess of a protein called HER2, which can drive cancer growth.
**You may be eligible if...**
- You are 18 or older
- You have confirmed HER2-positive metastatic solid tumor cancer
- Your cancer has spread to the brain (either untreated brain metastases not requiring immediate surgery/radiation, or previously treated brain metastases)
- You are in good enough health to tolerate the treatment
**You may NOT be eligible if...**
- Your brain metastases are rapidly growing and require immediate treatment
- You have severe liver, heart, or other organ problems
- You have had certain prior treatments that would make this combination unsafe
- You are pregnant or breastfeeding
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGTrastuzumab emtansine
Given by IV (vein)
DRUGTucatinib
Given by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05673928
Related Trials
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
NCT048999082 locations
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
NCT0578692427 locations
FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers
NCT076383717 locations
A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
NCT0665714430 locations
First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
NCT0728418610 locations