A Phase 1 interventional study of HPN536 Fixed IV 6 to 560 ng/kg and HPN536 1 Prime Step IV 600-1200 ng/kg Target in Advanced Cancers Associated With Mesothelin Expression, sponsored by Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 1, Interventional, and Treatment
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.)
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 95 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
One of the following progressive advanced or metastatic cancers:
Adequate bone marrow function, including:
Adequate liver function, including:
Key Exclusion Criteria:
HPN536 administered once weekly via IV infusion in doses ranging from 6 to 560 ng/kg
Biological: HPN536 Fixed IV 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)
Biological: HPN536 1 Prime Step IV 600-1200 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)
Biological: 2 Prime Step IV 900-14000 ng/kg Target
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)
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
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)