An open-label, Phase 1/2a study of HPN536 as monotherapy to assess the safety, tolerability and PK in patients with advanced cancers associated with mesothelin expression.(Phase 2 portion of the study was not conducted.)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Fixed dose IV cohorts at doses from 6 to 560 ng/kg
Step-dosing IV cohorts who received a single Prime Dose followed by the Target Dose (200/600 ng/kg, 200/1200 ng/kg, and 500/900 ng/kg)
Step-dosing IV cohorts who received 2 Prime Doses followed by the Target Dose (200/600/900 ng/kg and 200/600/1200 ng/kg; 500/900/1200 ng/kg, 500/900/1800 ng/kg, 500/900/3600 ng/kg, 500/900/7200 ng/kg, and 500/900/14400 ng/kg)
Mayo Clinic Arizona
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Assessment of Adverse Events by CTCAE 5.0 of HPN536
Assess safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with of patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, pancreatic adenocarcinoma, or mesothelioma (pleural and primary peritoneal) by adverse events (CTCAE v5.0)
Time frame: 3 years
Determine MTD/RP2D
Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)
Time frame: 2 years
Efficacy of HPN536 at the recommended Phase 2 dose: overall response rate (ORR)
Evaluate overall response rate (ORR) as assessed by RECIST
Time frame: 1 year
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University of California Los Angeles
Los Angeles, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
...and 6 more locations