HER2-positive Solid Cancers Clinical Trial
Official title:
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 1b, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) given as monotherapy in subjects with HER2-positive solid tumors
This study will be conducted in two parts: Part A (Dose Escalation): The purpose of Part A is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Part A will include any type of HER2-positive solid cancer. Part B (Dose Expansion): The purpose of Part B is to confirm the safety and tolerability of MT-5111 doses selected from those explored in Part A including the MTD or RP2D. Part B will include 3 types of HER2-positive solid cancers in the following 3 expansion groups: Group B1: Breast cancer; Group B2: gastric or gastroesophageal adenocarcinomas (GEA); and Group B3: Other HER2-positive solid cancers. The Breast Cancer cohort will start enrolling in parallel to Part A. Up to 178 eligible subjects will be identified and treated through competitive enrollment at multiple study centers globally In Parts A and B 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 three weekly doses of MT-5111 over a 21-day treatment cycle) Short-term 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. ;