Study of MT-5111 in HER2-positive Solid Tumors

  • Interventional
  • Recruiting
  • NCT04029922
Eligibility Details Visit

A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors

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

This study will be conducted in two sequential parts:

        - Part 1 (Dose Escalation): The purpose of Part 1 is to determine the Phase 2 dose (RP2D) to be used in Part 2. Part 1 will include any type of HER2-positive solid cancer.

        - Part 2 (Dose Expansion): The purpose of Part 2 is to confirm the safety and tolerability of the RP2D of MT-5111. Part 2 will include any type of HER2-positive solid cancer, including breast cancer, gastric or gastroesophageal adenocarcinomas (GEA).

     Up to 140 eligible subjects will be identified and treated through competitive enrollment at multiple study centers.

     In Parts 1 and 2 of the study, a subject may participate for the following four periods:

        - Screening (up to 28 days before first dose of MT-5111)

        - Treatment period (active period where a subject will receive doses of MT-5111 over a 21-day treatment cycle)

        - Follow-up (30 days after last dose of MT-5111)

        - Long-term follow-up (up to 24 months after the last dose of MT-5111)

     MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle, a cycle being defined as 21 days). A subject can continue receiving MT-5111 as long as it is well-tolerated, their disease has not worsened, or until the subject decides they no longer want to participate in the study.


Age Group
18 Years and up

Accepting Healthy Volunteers?

Inclusion Criteria:

         1. Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:

             - Part 1 (Dose-Escalation): All HER2-positive solid cancers are eligible

             - Part 2 (Dose-Expansion): Any type of HER2-positive solid cancer, including breast cancer, 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

         5. ECOG performance score of ≤ 1

         6. 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 4 weeks of study treatment start is allowed

         7. 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

         8. Cardiac Function:

             - Left ventricular ejection fraction (LVEF) ≥ 55% on the multigated acquisition (MUGA) scan (preferred) or echocardiogram (ECHO) assessment, 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, and

             - AST ≤ 3 x ULN and ALT ≤ 3 x ULN

             - < 5 x ULN (if hepatic metastases)

        Exclusion Criteria:

         1. History or current evidence of another tumor that is histologically distinct from the tumor under study

         2. Current evidence of new or growing CNS metastases during screening

             -Subjects with known CNS metastases will be eligible if they meet specified criteria

         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

At a Glance

National Government IDNCT04029922


Lead SponsorMolecular Templates, Inc.

Lead PhysicianGini Fleming


18 Years and up