Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Given Intravenously to Patients With Advanced Solid Tumors
This is a study of PEGPH20 in human subjects and is designed to evaluate the safety of
PEGPH20 and to determine the maximum tolerated dose of PEGPH20. All patients will receive
PEGPH20. Each group of patients will receive a higher dose than the previous group. This
will continue until the group with the highest planned dose completes the study or until a
group has major side effects from their assigned dose.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
To determine the recommended phase 2 dose (RP2D) of PEGPH20. To evaluate the safety and tolerability of PEGPH20 in advanced cancer patients over a range of doses.
Joy Zhu, M.D.
United States: Food and Drug Administration
|Premiere Oncology||Santa Monica, California 90404|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|T Gen Clinical Research Services||Scottsdale, Arizona 85258|