This study will evaluate safety, pharmacodynamics and biomarkers of subcutaneous (SC) DK210(EGFR) given as monotherapy and in combination with immunotherapy, chemotherapy or radiation.
This study will evaluate DK210(EGFR) as monotherapy and combination in subjects with advanced solid EGFR expressing cancers with documented progressive disease after at least one line of systemic treatment (staging performed by local standard).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Solution for SC administration
Short regimen radiation therapy (10 fractions or less)
IV administration of approved PD1 blocker
Single agent or combination of not more than two
City of Hope
Duarte, California, United States
Northwell Health
Manhasset, New York, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Incidence of Adverse Events (AEs) with DK210 (EGFR)
Based on toxicities observed
Time frame: Minimum of 90 days from initiation of experimental therapy
Identify recommended dose of DK210 (EGFR)
Based on toxicities observed
Time frame: Initiation of therapy up to day 90
Incidence of Adverse Events (AE) of DK210 (EGFR) in combination with radiation, chemotherapy, or checkpoint blockers in Parts B, C, D
Based on toxicities observed
Time frame: Minimum of 90 days from initiation of experimental therapy
Overall response rate (ORR)
Overall response rate (ORR) will be based on clinical examination and investigator review of radiographic images
Time frame: Initiation of therapy up to approximately 12 months
Best response rate at 9 weeks
Based on investigator clinical examination and review of radiographic images
Time frame: Initiation of therapy through Day 63
Progression-free (PFS)
Time from first dose of DK210 (EGFR) to first documentation of clinical or radiographic disease progression or death due to any cause, whichever occurs first.
Time frame: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival (OS)
Time from first dose of DK210 (EGFR) to the time of death
Time frame: Assessed up to 24 months
Serum concentrations of DK210 (EGFR) will be determined at various time points
Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level
Time frame: From initiation of treatment through 12 months (every 9 weeks)
Serum will be assayed for the presence of anti-DK210 (EGFR) antibodies
Results will be summarized by dose level
Time frame: From initiation of treatment through 12 months (every 9 weeks)
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Results will be summarized by dose level
Time frame: From initiation of treatment through day 63
Serum concentrations of proinflammatory cytokines such as IL-6, IL-10, TNFa, IL-1b, and interferon (IFN)-g will be assessed at various time points
Results will be summarized by dose level
Time frame: From initiation of treatment through 12 months (every 9 weeks)
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