NCT03872206

Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression

A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression Who Have Failed Standard Available Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.)

Conditions

• Advanced Cancers Associated With Mesothelin Expression

Interventions

Type	Name	Description
BIOLOGICAL	HPN536 Fixed IV 6 to 560 ng/kg	Fixed dose IV cohorts at doses from 6 to 560 ng/kg
BIOLOGICAL	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)
BIOLOGICAL	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)

Timeline

• Start date: 2019-04-16
• Primary completion: 2023-01-04
• Completion: 2023-01-04
• First posted: 2019-03-13
• Last updated: 2024-06-07

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study