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Brief Title: Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
Official Title: A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
Study ID: NCT05098132
Brief Summary: This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors.
Detailed Description: The phase 1a portion of the study is standard 3+3 dose escalation design to evaluate STK-012 as monotherapy and in combination with pembrolizumab in patients with selected solid tumors who have progressed after standard of care treatments. The phase 1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and in combination with pembrolizumab at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC San Diego Moores Cancer Center, La Jolla, California, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
Yale New Haven Hospital, Yale Cancer Center, New Haven, Connecticut, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute - Nashville, Nashville, Tennessee, United States
NEXT Virginia, Fairfax, Virginia, United States