“A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also knownas MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA)Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer”

• MVC-101 is a EGFR targeting T-cell engaging bispecific antibody

In this study, the sponsor and investigators want to learn:

• How much of the study agent can be given with an acceptable level of side effects
• The effects of the study agent (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed
• If research tests can be used in the future to predict who will benefit from TAK-186

This is a dose escalation/expansion study. Dose escalation means that the amount of the study agent given will be increased in each group of research participants, to find the most appropriate dose for further study.

During the dose escalation phase, there may be one or two lower doses given to you before you receive the full dose. The lower doses are called “lead-in doses”. In the dose expansion part of the study, a larger number of people receive the study agent dose determined to be appropriate in the dose escalation part of the study. If you are enrolled into the dose expansion phase, you will be assigned to receive the study agent at one of two doses determined in the dose escalation phase. The assignment is random, similar to flipping a coin. The study regimen will be given in 7 cycles. The cycles are 7 or 8 weeks long. You will receive the study agent once a week via an IV infusion (intravenously, meaning directly into a vein). This study is “open-label” which means that both you and your study doctor will know what dose of the study agent you are receiving. This study involves observation / hospitalization in Medical City Dallas.