At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 30 target
Drug / intervention
Trastuzumab emtansine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
- ✓HER2-positive metastatic solid tumor confirmed by histology with HER2 positivity defined by IHC 3+ or 2+ with FISH positive, or HER2 amplification by ISH/NGS, or activating ERBB2 mutation
- ✓Brain metastases status: untreated not requiring immediate therapy, previously treated with progression, or at least one measurable untreated lesion ≥0.5 cm and <3.0 cm
- ✓Measurable per RECIST v1.1 or evaluable extracranial disease
- ✓Age ≥18 years at time of consent
Key exclusion· 16
- ✕Any untreated brain lesions >3.0 cm in size
- ✕Any brain lesion requiring immediate local therapy or at risk from edema (e.g., brainstem lesions)
- ✕Ongoing systemic corticosteroids >4 mg dexamethasone equivalent daily for brain metastasis symptoms
- ✕Poorly controlled seizures (>1/week) or neurologic progression despite CNS-directed therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Trastuzumab emtansine and Tucatinib for Metastatic Solid Tumor and Brain Metastases. Currently recruiting, targeting 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Solid Tumor, Brain Metastases
CountriesUnited States
CollaboratorsGenentech, Inc., Seagen Inc.
Timeline
Phase 2Recruiting
2023202420252026202720282029
First PostedJan 2023
Enrollment StartMay 2023
TodayJul 2026
Primary CompletionMar 2027
Study CompletionMar 2029
First PostedJan 6, 2023
Enrollment StartMay 16, 2023
Primary CompletionMar 1, 2027
Study CompletionMar 1, 2029
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 3.5 years agoPrimary completion in 8 months
Interventions
Trastuzumab emtansinedrug
Given by IV (vein)
Tucatinibdrug
Given by PO