Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors

This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.

Inclusion Criteria:ECOG performance status of 0-1Life expectancy of >3 months according to the investigator's judgmentBy local standard confirmed progressive metastatic and/or locally advanced unresectable solid cancer with EGFR overexpression or amplificationMeasurable disease, defined as at least one (non-irradiated) lesion measurable on CT/MRI or bone scan as defined by RECIST 1.1.Progressive disease (PD) at study entry defined as one or more of the following criteria:Clinical PD with performance decline, clinical symptoms and/or observed tumor growthPD documented with imaging showing at least 20% growth (largest diameter) and/or new lesionsAdequate cardiovascular, hematological, liver, and renal function.Subjects have failed one or more lines of systemic therapy and have not been operated on or receiving anti-cancer medication for at least 4 weeks.Males and females of childbearing potential must agree to use effective contraception starting prior to the first day of treatment and continuing during treatmentAdditional criteria may applyExclusion Criteria:Subjects with documented diffuse peritoneal disease or persistent abundant ascitesSubjects with known prolonged QtC intervalConcomitant or recent (<4 weeks or 5 half-lives of the last treatment, whichever is shorter) treatment with agents with anti-tumor activity, including immunotherapies, or experimental therapies. Bone treatments and supportive care can be continuedMajor surgery within 4 weeks, Radiation therapy for the treatment of metastases within less than 3 weeks (if single fraction of radiotherapy, then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screeningUncontrolled intercurrent illness including, but not limited to, ongoing and uncontrolled infection (TBC, COVID or HIV patients treated with at least two anti-retroviral drugs and control of their infection with at least 500 /mm3 CD4+ T-cells in their blood and patients cured from Hepatitis B or C (i.e negativity of PCR) and liver function compatible with eligibility criteria are allowed to participate), multiple myeloma, multiple sclerosis, myasthenia gravis, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirementAny other conditions that, in the investigator's opinion, might indicate the subject to be unsuitable for the studyAdditional criteria may apply