32
Participants
Start Date
March 1, 2018
Primary Completion Date
September 30, 2023
Study Completion Date
November 1, 2025
APX005M treatment for recurrent or refractory primary malignant CNS tumor patients
"APX005M dosing will begin at 0.1 mg/kg, the APX005M dose may be increased (0.3, 0.45, 0.6 mg/kg) or decreased (0.03 mg/kg) in subsequent cohorts until the maximum tolerated dose (MTD) is reached or until dose level 3 (0.6 mg/kg) is complete without the MTD being defined.~APX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first."
APX005M treatment for newly diagnosed DIPG patients
"The starting dose of APX005M for the DIPG patients will be one dose level below the recommended phase II dose (RP2D) determined in Stratum 1 patients. The dose may be decreased or increased to the RP2D established in Stratum 1.~APX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first."
Memorial Sloan Kettering Cancer Center, New York
Children Hospital of Pittsburgh of UPMC, Pittsburgh
Children's Healthcare of Atlanta, Atlanta
St. Jude Children Research Hospital, Memphis
Cincinnati Children Hospital Medical Center, Cincinnati
Lurie Childrens Hospital-Chicago, Chicago
Baylor College of Medicine, Houston
Children's Hospital Colorado, Aurora
Children's Hospital Los Angeles, Los Angeles
Lucile Packard Children Hospital Stanford University, Palo Alto
Childrens National Medical Center, Washington D.C.
American Lebanese Syrian Associated Charities
OTHER
Pyxis Oncology, Inc
INDUSTRY
Solving Kids' Cancer
OTHER
Ty Louis Campbell Foundation
OTHER
A Kids' Brain Tumor Cure Foundation
OTHER
National Cancer Institute (NCI)
NIH
Pediatric Brain Tumor Consortium
NETWORK