Tucatinib and T-DM1 for HER2-positive Metastatic Solid Tumors with Brain Metastases
This study is testing if two drugs, tucatinib and ado-trastuzumab emtansine (T-DM1), can help control solid tumors that have spread to the brain. You may be able to join if you have a HER2-positive metastatic solid tumor (meaning your cancer cells have a lot of a protein called HER2) and your cancer has spread to your brain. Researchers will be looking at how well the drugs work to shrink or control the tumors in the brain, and also how safe the combination is. The study is currently unclear on its recruitment status and plans to enroll 30 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is planned to enroll 30 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The incidence of side effects will be measured through study completion, which is an average of 1 year.
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NCT05673928
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)
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~30 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Trastuzumab emtansineTucatinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 1 year.
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Ecaterina Dumbrava, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Untreated brain metastases not requiring immediate local CNS therapy
Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy
At least one measurable untreated brain lesion ≥0.5 cm and \<3.0 cm in the longest axis
Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets. 3. Measurable (per the RECIST v1.1) or evaluable extracranial disease. 4. Prior treatment with HER2-targeted treatments such as trastuzumab, pertuzumab, T-DM1, neratinib, lapatinib, or tucatinib is allowed, but not required. Patients with breast and gastric cancer must have received at least 1 line of HER2 targeted treatment. 5. Age ≥18 years at the time of consent. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix B). 7. Life expectancy ≥3 months, in the opinion of the investigator. 8. Adequate hematological and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to study treatment initiation:
Absolute neutrophil count ≥1,200/μL
Platelet count ≥100,000/μL
Hemoglobin ≥9g/dL
Total bilirubin ≤1.5 × upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if conjugated bilirubin is ≤1.5 × ULN
Transaminases (AST/ALT) ≤1.5 × ULN (≤5 × ULN if liver metastases are present)
Creatinine level \<1.5 x ULN or estimated glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) study equation as applicable. 9. International normalized ratio (INR) and partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) ≤1.5 × ULN, unless on medication known to alter INR and PTT/aPTT. Proprietary Information of MD Anderson Protocol 2021-0899 v.5.0,04/24/2023 28 10. LVEF ≥50% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan documented within 3weeks prior to study treatment initiation. 11. For patients of childbearing potential, as defined in Section 4.3, the following stipulations apply:
Must have a negative serum or urine pregnancy test (minimum sensitivity of 25 mIU/mL or equivalent units of beta-human chorionic gonadotropin \[β-hCG\]) result within 3 days prior to study treatment initiation. A patient with a false positive result and documented verification that the patient is not pregnant will be eligible.
Must agree not to try to become pregnant during the study and for at least 7 months after the final dose of study treatment
Must agree not to breastfeed or donate ova starting at the time of informed consent and continuing through the study and for 7 months after the final dose of study treatment
If sexually active in a way that could lead to pregnancy, must consistently use highly effective methods of birth control (i.e., methods that achieve a failure rate of \<1% per year when used consistently and correctly) starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment.
Must agree not to donate sperm starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment
If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use a barrier method of birth control starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment
If sexually active with a person who is pregnant or breastfeeding, must consistently use a barrier method of birth control starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment. 13. The patient must provide written informed consent. 14. Must be willing to undergo biopsy as required by the study, if clinically considered safe and feasible by the investigator.
Alopecia;
Neuropathy, which must have resolved to ≤ Grade 2;
Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely. 7. Clinically significant cardiopulmonary disease such as:
Ventricular arrhythmia requiring therapy
Symptomatic hypertension or uncontrolled asymptomatic hypertension as determined by the investigator
Any history of symptomatic CHF, left ventricular systolic dysfunction, or decrease in LVEF
Severe dyspnea at rest (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] ≥ Grade 3) due to complications of advanced malignancy or hypoxia requiring supplementary oxygen therapy
Grade 2 or greater corrected QT interval (QTc) prolongation on screening electrocardiogram (ECG). 8. Known myocardial infarction or unstable angina within 6 months prior to study treatment initiation. 9. Unable for any reason to undergo contrast MRI of the brain. 10. Have used a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to study treatment initiation. Concomitant use of strong CYP3A4 inducers or CYP2C8 inducers or inhibitors is also prohibited during study treatment and for 2 weeks after discontinuation of study treatment. Use Proprietary Information of MD Anderson of sensitive CYP3A substrates should be avoided 2 weeks prior to study treatment initiation and during study treatment. 11. Known carrier of hepatitis B or hepatitis C virus or has other known chronic liver disease. 12. Known positive human immunodeficiency virus status. 13. Patients who are pregnant, breastfeeding, or planning to become pregnant from the time of informed consent until 7 months after the last dose of study treatment. 14. Unable to swallow pills or has significant GI disease that would preclude adequate oral absorption of medication. 15. Other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact patient safety or compliance with study procedures. 16. Evidence within 1 year of the start of study treatment of another malignancy that required systemic treatment. 17. Patients who are eligible for the HER2CLIMB-02 study (NCT03975647) and they can be enrolled in that study.
Exclusion
Any untreated brain lesions \>3.0 cm in size
What this trial measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year.