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

Trial Status: Active

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.

Inclusion Criteria

  • 1. Patients ≥18 years of age 2. One of the following progressive advanced or metastatic cancers: 1. Epithelial ovarian, fallopian tube, or primary peritoneal cancer (Part 1 and Part 2, Group 1 only) that is platinum refractory or platinum resistant 2. Pancreatic adenocarcinoma (Part 1 and Part 2, Group 2 only) that is locally advanced, and now with progressive disease on or after front-line treatment 3. Malignant mesothelioma with epithelioid histology, pleural (Part 1 and Part 2, Group 3 only) or primary peritoneal (Part 1 and Part 2, Group 3 only) 3. For Part 2 only - Measurable disease according to RECIST v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mRECIST v1.1 for patients with pleural mesothelioma 4. Available archival tissue sample or fresh biopsy tissue sample must be obtained prior to enrollment 5. For patients previously treated with systemic chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent, discontinuation must have occurred ≥2 weeks, or at least 5 half-lives, whichever is longer, prior to start of study drug. The maximum washout period will not exceed 4 weeks 6. ECOG performance status of 0 or 1 7. Adequate bone marrow function, including: 1. Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 x 109/L 2. Platelets ≥100,000/mm3 or ≥100 x 109/L 3. Hemoglobin (Hgb) ≥10 g/dL 8. Adequate renal function, including estimated creatinine clearance ≥30 mL/min 9. Adequate liver function, including: 1. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) unless the patient has documented Gilbert syndrome in which case the maximum total serum bilirubin should be <5 mg/dL 2. Aspartate and alanine transaminase (AST and ALT) ≤2.5 x ULN or AST/ALT ≤5 x ULN for patients with liver metastases 10. Serum albumin as follows: 1. ≥30 mg/mL for patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or mesothelioma 2. Within normal limits for patients with pancreatic adenocarcinoma 11. Patients with pancreatic adenocarcinoma: C-reactive protein (CRP) within normal limits Key Exclusion Criteria: 1. Previously treated or current brain metastases. Note: 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. Concurrent treatment with anti- TNFα therapies, systemic corticosteroids, or other immune suppressive drugs within the 2 weeks prior to Screening 3. Patients with pancreatic adenocarcinoma: Any ascites within 1 month prior to screening 4. History of or known or suspected autoimmune disease 5. History of clinically significant cardiovascular disease 6. Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Xiomara Menendez
Phone: 323-865-0212
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Kim Kelly
Phone: 310-206-8309
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Xiomara Menendez
Phone: 323-865-0212
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Xiomara Menendez
Phone: 323-865-0212

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Michael David Offin
Phone: 646-449-1778

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Harpoon Therapeutics

  • Primary ID HPN536-2001
  • Secondary IDs NCI-2019-05711
  • Clinicaltrials.gov ID NCT03872206