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

Phase 1

Waitlist Available

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called HPN536 to see if it is safe and tolerable for patients with advanced cancers that have a protein called mesothelin. The drug works by attaching to this protein on cancer cells, which may help the body attack and kill these cells. HPN536 is designed to target mesothelin-expressing solid tumors.

Eligible Conditions

Mesothelin-Associated Cancers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Adverse Events by CTCAE 5.0 of HPN536

Determine MTD/RP2D

Efficacy of HPN536 at the recommended Phase 2 dose: overall response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Fixed IVExperimental Treatment1 Intervention

HPN536 administered once weekly via IV infusion in doses ranging from 6 to 560 ng/kg

Group II: 2 Prime Step IV 900-14000 ng/kg TargetExperimental Treatment1 Intervention

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)

Group III: 1 Prime Step IV 600-1200 ng/kg TargetExperimental Treatment1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HPN536 1 Prime Step IV 600-1200 ng/kg Target

2019

Completed Phase 1

~100

HPN536 Fixed IV 6 to 560 ng/kg

2019