OncoMatch/Clinical Trials/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)
Is NCT05673928 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab emtansine and Tucatinib for metastatic solid tumor.
Treatment: Trastuzumab emtansine · Tucatinib — To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) activating mutation
Required: HER2 (ERBB2) amplification
Required: HER2 (ERBB2) overexpression (ihc 3+ or 2+ and fish positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: HER2-targeted therapy
Patients with breast and gastric cancer must have received at least 1 line of HER2 targeted treatment
Lab requirements
Blood counts
Absolute neutrophil count ≥1,200/μL; Platelet count ≥100,000/μL; Hemoglobin ≥9g/dL
Kidney function
Creatinine <1.5 x ULN or estimated GFR ≥50 mL/min/1.73 m2 (MDRD equation)
Liver function
Total bilirubin ≤1.5 × ULN (except Gilbert's disease: conjugated bilirubin ≤1.5 × ULN); AST/ALT ≤1.5 × ULN (≤5 × ULN if liver metastases present)
Cardiac function
LVEF ≥50% by ECHO or MUGA within 3 weeks prior to study treatment initiation
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 × 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. LVEF ≥50% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan documented within 3 weeks prior to study treatment initiation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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