Dose-finding Phase 1 Trial: Evaluating Safety and Biomarkers Using DK210 (EGFR) for Inoperable Locally Advanced and/or Metastatic EGFR+ Tumors With Progressive Disease Failing Systemic Therapy

DK210 is an EGFR-targeting IL2/IL10

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
• How the study agent is acting on your body

There are three parts to the study: (1) Screening, (2) Treatment, and (3) Follow-up. You will not have any tests or other procedures done for the study until after you agree to be in the study and sign this consent form. The total duration of the study is approximately 1 year.

The first week will consist of two full days (day 1 and 5) and a half day (day 3) at the clinic.  All other treatments will take place at home. The research staff will explain and administer the first injection on Day 1 and watch you and/or your caregiver injecting on Day 3 and 5.

In the first week, the care team will observe you, measure drug uptake, and perform multiple blood draws. Each vial or syringe of the investigational drug is intended for a single dosing only and normal dosing will consist of 3 injections per week on Monday, Wednesday, and Friday (at the same timepoint of the day).