Open Actively Recruiting

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

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A
  • Patients ≥18 years of age
  • One of the following progressive advanced or metastatic cancers:
    • Epithelial ovarian, fallopian tube, or primary peritoneal cancer (Part 1 and Part 2, Group 1 only) that is platinum refractory or platinum resistant
    • 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
    • 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)
  • 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
  • Available archival tissue sample or fresh biopsy tissue sample must be obtained prior to enrollment
  • 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
  • ECOG performance status of 0 or 1
  • Adequate bone marrow function, including:
    • Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 x 109/L
    • Platelets ≥100,000/mm3 or ≥100 x 109/L
    • Hemoglobin (Hgb) ≥10 g/dL
  • Adequate renal function, including estimated creatinine clearance ≥30 mL/min
  • Adequate liver function, including:
    • 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
    • Aspartate and alanine transaminase (AST and ALT) ≤2.5 x ULN or AST/ALT ≤5 x ULN for patients with liver metastases
  • Serum albumin as follows:
    • ≥30 mg/mL for patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or mesothelioma
    • Within normal limits for patients with pancreatic adenocarcinoma
  • Patients with pancreatic adenocarcinoma: C-reactive protein (CRP) within normal limits

Key Exclusion Criteria:

  • 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
  • Concurrent treatment with anti- TNFα therapies, systemic corticosteroids, or other immune suppressive drugs within the 2 weeks prior to Screening
  • Patients with pancreatic adenocarcinoma: Any ascites within 1 month prior to screening
  • History of or known or suspected autoimmune disease
  • History of clinically significant cardiovascular disease
  • Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements

Join this Trial

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Study Stats
Protocol No.
19-001596
Category
Hematology-Oncology
Oncology
Contact
Kimberly Kelly
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT03872206
For detailed technical eligibility, visit ClinicalTrials.gov.