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

Phase 1
Completed
Conditions
Advanced Cancers Associated With Mesothelin Expression
Registration Number
NCT03872206
Lead Sponsor
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Brief 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.)

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
95
Inclusion Criteria

Not provided

Exclusion Criteria
  1. Brain metastases unless previously treated. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, and have no evidence of new or enlarging brain metastases
  2. Evidence of retroperitoneal fibrosis, mesothelial surface (pleura, pericardium, peritoneum) thickening of ≥4 mm; significant or increasing pleural/pericardial effusions, ascites or pericarditis at baseline deemed unrelated to the underlying malignancy based on computed tomography (CT), magnetic resonance imaging (MRI), or echocardiogram (ECHO); or prior history of pleurodesis, retroperitoneal fibrosis or mediastinal fibrosis.
  3. Previous Grade 3/4 infusion or hypersensitivity reaction (not immunotoxicity) to treatment with another monoclonal antibody.
  4. For patients with tumor types other than pleural mesothelioma: Ascites requiring >1 paracentesis for therapeutic purposes (i.e., not for diagnosis) within 1 month prior to Cycle 1 Day 1.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Primary Outcome Measures
NameTimeMethod
Assessment of Adverse Events by CTCAE 5.0 of HPN5363 years

Assess safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with of patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, pancreatic adenocarcinoma, or mesothelioma (pleural and primary peritoneal) by adverse events (CTCAE v5.0)

Determine MTD/RP2D2 years

Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)

Efficacy of HPN536 at the recommended Phase 2 dose: overall response rate (ORR)1 year

Evaluate overall response rate (ORR) as assessed by RECIST

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

Mayo Clinic Arizona

🇺🇸

Phoenix, Arizona, United States

University of Southern California

🇺🇸

Los Angeles, California, United States

University of California Los Angeles

🇺🇸

Los Angeles, California, United States

Mayo Clinic Florida

🇺🇸

Jacksonville, Florida, United States

University of Chicago

🇺🇸

Chicago, Illinois, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Mayo Clinic Rochester

🇺🇸

Rochester, Minnesota, United States

Washington University School of Medicine in St. Louis

🇺🇸

Saint Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

Cleveland Clinic Taussig Cancer Institute

🇺🇸

Cleveland, Ohio, United States

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Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States

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