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Brief Title: Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors
Official Title: A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors
Study ID: NCT03364400
Brief Summary: This study is an an open-label Phase I trial of VT1021 in patients with advanced solid tumors. Patients must have recurrent or advanced cancer (i.e., solid tumors) for which standard therapy offers no curative potential.
Detailed Description: This is an open-label Phase I study of VT1021 in patients with advanced solid tumors. The study will include a Dose Escalation Phase and a Dose Expansion Phase. Upon determination of the Recommended Phase 2 Dose in the Dose Escalation Phase, the Dose Expansion Phase will be opened. The Dose Expansion Phase will include cohorts in ovarian, pancreatic, triple negative breast cancer, glioblastoma and CD36-high patients in order to confirm the tolerability of VT1021 against specific tumor types.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Florida Cancer Specialists, Sarasota, Florida, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Horizon Oncology Center, Lafayette, Indiana, United States
The Johns Hopkins Hospital, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel, Boston, Massachusetts, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
MD Anderson Cancer Center, Houston, Texas, United States
START, San Antonio, Texas, United States
Name: Judy Chaio, MD
Affiliation: Medical Director
Role: STUDY_DIRECTOR