230
Participants
Start Date
August 29, 2018
Primary Completion Date
December 30, 2025
Study Completion Date
December 30, 2025
Phase 1b: APG-115+pembrolizumab
"dose escalation of APG-115 in combination with label dose of pembrolizumab, Four dose levels of APG-115 will be tested: 50, 100, 150, and 200 mg. APG-115 will be administrateddose escalation of APG-115 in combination with label dose of pembrolizumab, Fourfour dose levels of APG-115 will be tested: 50, 100, 150, and 200 mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as there are cycles every 3-weeks a cycle. Pembrolizumab is administrated following FDA approved label dose, i.e., 200 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.~Phase II: Combination of APG-115 at 150 mg (RP2D) and pembrolizumab or APG-115 monotherapy alone."
Queensland Children's Hospital, South Brisbane
Flinders Medical Centre, Bedford Park
Memorial Sloan Kettering, New York
Penn State Hershey Medical Center Cancer Institute, Hershey
Thomas Jefferson University Hospital, Philadelphia
Children's National Research Institute, Washington D.C.
Virginia Cancer Specialists, Fairfax
Duke Cancer Institute, Durham
Sarah Cannon/FCSRI, Fort Myers
Sarah Cannon Cancer Center, Nashville
Cleveland Clinic, Cleveland
Cincinnati Children's Hospital Medical Center, Cincinnati
Washington University School of Medicine, St Louis
Highlands Oncology, Rogers
University of Texas MD Anderson Cancer Center, Houston
Next Oncology, San Antonio
University of Arizona Cancer Center, Tucson
UCLA Hematology & Oncology Clinic, Los Angeles
Sarcoma Oncology Research Center, Santa Monica
Metro South Hospital and Health Services via Princess Alexandra Hospital, Brisbane
Austin Health, Heidelberg
Lead Sponsor
Merck Sharp & Dohme LLC
INDUSTRY
Ascentage Pharma Group Inc.
INDUSTRY