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

Status: Active

Description

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.

Eligibility Criteria

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 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 or primary peritoneal (Part 2, Group 3 only) that is progressive disease following frontline platinum-based chemotherapy 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 ≥50 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 ≥30 mg/mL 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. History of or known or suspected autoimmune disease 4. History of clinically significant cardiovascular disease 5. Second primary malignancy that has not been in remission for greater than 3 years 6. Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Approved
Contact: Kim Kelly
Phone: 310-206-8309
Email: kmkelly@mednet.ucla.edu

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: In review
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Harpoon Therapeutics

Trial IDs

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