Study of MT-5111 in HER2-positive Solid Tumors

Inclusion Criteria

• •1. Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:
• •* Part A (Dose-Escalation): All HER2-positive solid cancers are eligible
• •* Part B (Dose-Expansion): Any type of HER2-positive solid cancer, including breast cancer, and gastric or gastroesophageal adenocarcinomas (GEA).
• •2. HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a metastatic lesion in cases of metastatic cancers).
• •3. Relapsed or refractory to or intolerant of existing therapy(ies)
• •4. At least 1 measurable or evaluable lesion according to RECIST 1.1 (Subjects with evaluable disease only may be included in the dose escalation phase)
• •5. ECOG performance score of ≤ 1
• •6. Adequate Bone marrow function as determined by:
• •* Absolute neutrophil count (ANC) ≥ 1,000/mm3
• •* Platelet count ≥ 75,000 mm³ and
• •* Hemoglobin ≥ 8.0 g/dL
• •* Red blood cell transfusion within 2 weeks of study treatment start is allowed if hemoglobin levels remain stable
• •7. Kidney function:
• •* Creatinine clearance (CLcr) ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula
• •8. Cardiac Function:
• •* Left ventricular ejection fraction (LVEF) ≥ 55% on the echocardiogram (ECHO) assessment (preferred), or multigated acquisition (MUGA) scan, and QTcF ≤ 480 ms for women and QTcF ≤ 450 ms for men \[average from three QTcF values on the triplicate 12-lead electrocardiogram (ECG)\] at baseline
• •9. Hepatic function:
• •* Total bilirubin ≤ 1.5 x ULN, or ≤ 3 x ULN for subjects with Gilbert's Syndrome and
• •* AST ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis) and ALT ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis)
• •3. Evidence of CTCAE Grade \>1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria
• •4. History or evidence of significant cardiovascular disease
• •5. Current evidence of active, uncontrolled hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) (evidenced by detectable viral load by PCR) or acquired immunodeficiency syndrome (AIDS) related illness
• •6. Current evidence of ≥ grade 2 underlying pulmonary disease
• •7. Certain exclusionary prior treatments