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Brief Title: A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions
Official Title: A Phase 1 Dose Escalation Trial of SYN125 Single Agent in Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Epithelial Cancers With EGFR Expressions.
Study ID: NCT04363242
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint Louis, Missouri, United States
University of Oklahoma, Peggy and Charles Stephenson Cancer Center, 800 Northeast 10th Street, Oklahoma City, Oklahoma, United States
Name: Ding Wang, MD
Affiliation: Henry Ford Hospital
Role: PRINCIPAL_INVESTIGATOR