A Phase 1 Dose Escalation Trial of SYN125 Single Agent in the Treatment of Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Cancer of the Internal or External Lining of the Body.
Humans have an immune system that can protect and fight infections and abnormal cells. T-cells are a type of cell produced by the body that can attack and kill cancer cells. Unfortunately, many cancer cells have ways preventing T-cells from working properly. SYN125 and SYN004 can make T-cells work again. This is a study to find the maximum tolerated dose of SYN125 when it is used as a single treatment (Part A) for solid tumors, and when it is used as a combined treatment with a fixed dose of SYN004 (Part B), in patients with epithelial cancers with EGFR (epithelial growth factor receptor) expressions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
University of Kansas Cancer Center, Clinical Research Center, 4350 Shawnee Mission Parkway, MS 6004
Fairway, Kansas, United States
Henry Ford Health System, Henry Ford Hospital
Brownstown, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Oklahoma, Peggy and Charles Stephenson Cancer Center, 800 Northeast 10th Street
Oklahoma City, Oklahoma, United States
Part A: Incidence of dose-limiting toxicities (DLTs)
Incidence of DLTs with single agent SYN125
Time frame: Up to Day 28
Part B: Incidence of dose-limiting toxicities (DLTs)
Incidence of DLTs with SYN125 and fixed-dose SYN004 administered in combination
Time frame: Up to Day 28
Incidence of Adverse Events (AEs)
Incidence of Adverse Events (AEs)
Time frame: Up to Day 50
Incidence of Clinical Laboratory Abnormalities
Defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
Time frame: Up to Day 50
Serum concentration time profiles (Area under the serum concentration-time curve from time zero to the last measurable concentration)
Serum concentration time profiles (Area under the serum concentration-time curve from time zero to the last measurable concentration) of SYN125 and SYN004
Time frame: Up to Day 106
Area under the serum concentration time-curve over the dosing interval
Area under the serum concentration time-curve over the dosing interval of SYN125 and SYN004
Time frame: Up to Day 106
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of SYN125 and SYN004
Time frame: Up to Day 106
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Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax) of SYN125 and SYN004
Time frame: Up to Day 106
Time to maximum observed serum concentration (Tmax)
Time to maximum observed serum concentration (Tmax) of SYN125 and SYN004
Time frame: Up to Day 106
Terminal elimination half-life (t1/2)
Terminal elimination half-life (t1/2) of SYN125 and SYN004
Time frame: Up to Day 106
Clearance
Clearance of SYN125 and SYN004
Time frame: Up to Day 106
Volume of distribution at steady-state (Vss)
Volume of distribution at steady-state (Vss) of SYN125 and SYN004
Time frame: Up to Day 106