Open Actively Recruiting

Study of MT-5111 in HER2-positive Solid Tumors


Brief Summary

This will be a Phase 1b, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) in subjects with HER2-positive solid tumors

Primary Purpose
Study Type
Phase I


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

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, gastric or gastroesophageal adenocarcinomas (GEA). HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a metastatic lesion in cases of metastatic cancers). Relapsed or refractory to or intolerant of existing therapy(ies) At least 1 measurable or evaluable lesion according to RECIST 1.1 ECOG performance score of ≤ 1 Bone marrow function: Absolute neutrophil count (ANC) ≥ 1,000/mm3 Platelet count ≥ 75,000 mm³ and Hemoglobin ≥ 8.0 g/dL No red blood cell transfusion within 2weeks of study treatment start is allowed Kidney function: (eGFR) ≥ 50 mL/min calculated by the Cockcroft-Gault formula Subjects with CLcr ≥ 50 mL/min will be eligible irrespective of the eGFR result 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 Hepatic function: Total bilirubin ≤ 1.5 x ULN, and AST ≤ 3 x ULN and ALT ≤ 3 x ULN < 5 x ULN (if hepatic metastases)

Exclusion Criteria:

History or current evidence of another tumor that is histologically distinct from the tumor under study Current evidence of new or growing CNS metastases during screening -Subjects with known CNS metastases will be eligible if they meet specified criteria 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 History or evidence of significant cardiovascular disease 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 Current evidence of ≥ grade 2 underlying pulmonary disease Certain exclusionary prior treatments

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Study Stats
Protocol No.
Lisa Yonemoto
  • TRIO-US - Fullerton
  • TRIO-US - Hollywood FL
  • TRIO-US - Los Alamitos CA
  • TRIO-US - Orlando FL
  • UCLA Santa Monica
For Providers
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