Actively Recruiting
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)
Led by M.D. Anderson Cancer Center ยท Updated on 2026-01-21
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of tucatinib and ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic solid tumors that have spread to the brain. This phase II study aims to measure how well this drug combination controls brain tumors, assesses tumor response using specific criteria, and evaluates safety and survival outcomes. The study also explores biomarkers related to treatment response and resistance. Participants receive tucatinib tablets twice daily about 8 to 12 hours apart and T-DM1 through a vein infusion on the first day of each 21-day cycle. The treatment continues in cycles, with the study monitoring tumor activity in the brain and elsewhere in the body. The study allows prior HER2-targeted treatments and includes patients with measurable brain and extracranial disease. During the study, participants undergo brain MRI scans, blood tests to check organ function, and other evaluations to monitor tumor changes and side effects. Researchers track adverse events using standard criteria throughout about one year of participation. Patients must provide consent and may undergo tumor biopsies if safe. The study also monitors overall survival, progression-free survival, and duration of response to treatment.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Histologically confirmed HER2-positive metastatic solid tumor
- Untreated or progressing brain metastases not requiring immediate local therapy
- At least one measurable untreated brain lesion 0.5 cm or larger and less than 3.0 cm
- Measurable or evaluable extracranial disease
- ECOG performance status of 0 to 2
- Life expectancy of at least 3 months
- Adequate blood counts and organ function per laboratory tests within 28 days
- LVEF 50% or higher by echocardiogram or MUGA scan within 3 weeks
- Negative pregnancy test if applicable and agreement to use effective birth control
- Willingness to provide informed consent
- Willing to undergo biopsy if considered safe and feasible
You will not qualify if you...
- Brain lesions larger than 3.0 cm or requiring immediate local therapy
- Use of systemic corticosteroids over 4 mg daily dexamethasone or equivalent
- Poorly controlled seizures or neurologic progression from brain metastases
- Allergic reactions to trastuzumab or similar compounds except mild infusion reactions
- Recent systemic anticancer therapy or investigational agents within 5 half-lives or 21 days
- Unresolved toxicities from prior cancer treatments above Grade 1 except certain exceptions
- Significant cardiopulmonary disease or symptomatic heart conditions
- Recent myocardial infarction or unstable angina within 6 months
- Inability to undergo contrast brain MRI
- Use of strong CYP2C8 or CYP3A4 inhibitors or inducers prior to study
- Known chronic liver disease or hepatitis B/C carrier
- HIV positive status
- Pregnancy, breastfeeding, or planning pregnancy during and 7 months after treatment
- Inability to swallow pills or gastrointestinal conditions affecting absorption
- Other medical or social factors affecting safety or compliance
- Another malignancy requiring systemic treatment within 1 year
- Eligibility for HER2CLIMB-02 study (NCT03975647)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive tucatinib tablets twice daily and ado-trastuzumab emtansine (T-DM1) by vein on Day 1 of each 21-day cycle.
At least 1 visit every 3 weeks per cycle for infusions and assessments
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Ecaterina Dumbrava, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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