HPN536 for Mesothelin-Associated Cancers

Phase-Based Progress Estimates
Mesothelin-Associated CancersHPN536 - Biological
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new drug, HPN536, to see if it is safe and effective in treating advanced cancers associated with mesothelin expression.

Eligible Conditions
  • Mesothelin-Associated Cancers

Treatment Effectiveness

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 3 years

1 year
Efficacy of HPN536 at the recommended Phase 2 dose: overall response rate (ORR)
2 years
Determine MTD/RP2D
3 years
Assessment of Adverse Events by CTCAE 5.0 of HPN536
Day 21
Assess initial safety and determination of recommended Phase 2 dose: Dose limiting toxicity

Trial Safety

Trial Design

2 Treatment Groups

HPN536-2001 - Part 1 (Dose Escalation)
1 of 2
HPN536-2001 - Part 2 (Dose Expansion)
1 of 2

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: HPN536 · No Placebo Group · Phase 1 & 2

HPN536-2001 - Part 1 (Dose Escalation)
Experimental Group · 1 Intervention: HPN536 · Intervention Types: Biological
HPN536-2001 - Part 2 (Dose Expansion)
Experimental Group · 1 Intervention: HPN536 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Harpoon TherapeuticsLead Sponsor
3 Previous Clinical Trials
167 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have malignant mesothelioma with epithelioid histology, pleural or peritoneal type.
A tissue sample is required for enrollment.
You have an absolute neutrophil count (ANC) of 1500/mm3 or more.
Platelets ≥100,000/mm3 or ≥100 x 109/L.
You have adequate renal function, including estimated creatinine clearance ≥30 mL/min.