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

NCT03872206 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-06-07

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2023-01-04
Completion
2023-01-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872206 on ClinicalTrials.gov