Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
14
PEGylated recombinant human hyaluronidase
T Gen Clinical Research Services
Scottsdale, Arizona, United States
Premiere Oncology
Santa Monica, California, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
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.
Time frame: 28 days
To determine the pharmacokinetics (PK) of PEGPH20
Time frame: 28 days
To determine the dose-limiting toxicities (DLTs) of PEGPH20.
Time frame: 28 days
To observe patients for any evidence of anti-tumor activity (efficacy).
Time frame: 28 days
To explore pharmacodynamic endpoints that may guide the further development of PEGPH20.
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.