MC# 23-08 - DEKA-1 a dose-finding Phase I trial: evaluating safety and biomarkers using DK210 (EGFR) for inoperable locally advanced and/or metastatic EGFR+ tumors with progressive disease failing systemic therapy
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Agent(s): DK210 (EGFR)
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Disease Type(s): Colorectal, Melanoma, Solid Tumor, Renal, Squamous Cell, Lung-NSCLC
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Phase(s): I
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Drug Classification(s): Targeted Therapy, Cytokines, Immunotherapy
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Molecular Target(s): EGFR
Mechanism of Action
EGFR-targeting IL2/IL10
Purpose
In this study, the sponsor and investigators want to learn:
- How much of DK210 (EGFR) can be given with an acceptable level of side effects alone or in combination with immunotherapy, chemotherapy, or radiation
- The effects of DK210 (EGFR) (good and bad) alone or in combination with immunotherapy, chemotherapy, or radiation
- How much of DK210 (EGFR) is absorbed into the blood and how fast it is removed
Inclusion Criteria
- ECOG performance status of 0-1
- Life expectancy of >3 months according to the investigator's judgment
- By local standard confirmed progressive metastatic and/or locally advanced unresectable solid cancer with EGFR overexpression or amplification
- Measurable 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 growth
- PD documented with imaging showing at least 20% growth (largest diameter) and/or new lesions
- Adequate 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 treatment
- Additional criteria may apply
Exclusion Criteria
- Subjects with documented diffuse peritoneal disease or persistent abundant ascites
- Subjects with known prolonged QTc interval
- Concomitant 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 continued.
- Major 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 screening
- Uncontrolled 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 requirement
- Any other conditions that, in the investigator's opinion, might indicate the subject to be unsuitable for the study
- Additional criteria may apply
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
