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Brief Title: A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors
Official Title: A Phase 1/1b Study of MPT-0118 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Refractory Solid Tumors
Study ID: NCT04859777
Brief Summary: This is a Phase 1/1b open-label, dose-escalation, and cohort expansion study with BID (tablet) oral dose of MPT-0118 in subjects with advanced or metastatic refractory solid tumors. The study will be conducted in 3 parts: * Part A: MPT-0118 dose-escalation * Part B: MPT-0118 dose-escalation in combination with pembrolizumab * Part C: Cohort expansion of MPT-0118 in combination with pembrolizumab
Detailed Description: MPT-0118 will be administered orally twice daily (BID). Pembrolizumab will be administered intravenously (IV) at a dose of 200 mg every 3 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
St. John's Cancer Center, Santa Monica, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Columbia University, New York, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Name: Arthur DeCillis, MD
Affiliation: Monopteros Therapeutics Inc.
Role: STUDY_DIRECTOR