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Monoclonal Antibodies

Fixed IV for Cancer

Phase 1
Waitlist Available
Research Sponsored by Harpoon Therapeutics
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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)

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
Completed Phase 1
~100
2 Prime Step IV 900-14000 ng/kg Target
2019
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Harpoon TherapeuticsLead Sponsor
3 Previous Clinical Trials
363 Total Patients Enrolled
~15 spots leftby Sep 2025
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