Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression
NCT ID: NCT03872206
Last Updated: 2024-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
95 participants
INTERVENTIONAL
2019-04-16
2023-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Fixed IV
HPN536 administered once weekly via IV infusion in doses ranging from 6 to 560 ng/kg
HPN536 Fixed IV 6 to 560 ng/kg
Fixed dose IV cohorts at doses from 6 to 560 ng/kg
1 Prime Step IV 600-1200 ng/kg Target
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)
HPN536 1 Prime Step IV 600-1200 ng/kg Target
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)
2 Prime Step IV 900-14000 ng/kg Target
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)
2 Prime Step IV 900-14000 ng/kg Target
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)
Interventions
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HPN536 Fixed IV 6 to 560 ng/kg
Fixed dose IV cohorts at doses from 6 to 560 ng/kg
HPN536 1 Prime Step IV 600-1200 ng/kg Target
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)
2 Prime Step IV 900-14000 ng/kg Target
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)
Eligibility Criteria
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Exclusion Criteria
2. Evidence of retroperitoneal fibrosis, mesothelial surface (pleura, pericardium, peritoneum) thickening of ≥4 mm; significant or increasing pleural/pericardial effusions, ascites or pericarditis at baseline deemed unrelated to the underlying malignancy based on computed tomography (CT), magnetic resonance imaging (MRI), or echocardiogram (ECHO); or prior history of pleurodesis, retroperitoneal fibrosis or mediastinal fibrosis.
3. Previous Grade 3/4 infusion or hypersensitivity reaction (not immunotoxicity) to treatment with another monoclonal antibody.
4. For patients with tumor types other than pleural mesothelioma: Ascites requiring \>1 paracentesis for therapeutic purposes (i.e., not for diagnosis) within 1 month prior to Cycle 1 Day 1.
18 Years
ALL
No
Sponsors
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Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
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
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Molloy ME, Austin RJ, Lemon BD, Aaron WH, Ganti V, Jones A, Jones SD, Strobel KL, Patnaik P, Sexton K, Tatalick L, Yu TZ, Baeuerle PA, Law CL, Wesche H. Preclinical Characterization of HPN536, a Trispecific, T-Cell-Activating Protein Construct for the Treatment of Mesothelin-Expressing Solid Tumors. Clin Cancer Res. 2021 Mar 1;27(5):1452-1462. doi: 10.1158/1078-0432.CCR-20-3392. Epub 2020 Dec 1.
Other Identifiers
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HPN536-2001
Identifier Type: -
Identifier Source: org_study_id
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