About the Trial
Study of MT-5111 in 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.