MC# 19-21 - A Phase I/IIa Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients with Advanced Cancers Associated with Mesothelin Expression Who Have Failed Standard Available Therapy

  • Agent(s): HPN536
  • Disease Type(s): Mesothelioma, Pancreatic, Ovarian
  • Phase(s): I, II
  • Drug Classification(s): Targeted Therapy, Immunotherapy, Monoclonal Antibody
  • Molecular Target(s): CD3, MSLN

Mechanism of Action

HPN536, a T cell-engaging, Mesothelin/CD3-specific TriT Cell Activating Construct specific to human MSLN

Purpose

  • Assess initial safety of HPN536 and determine the recommended Phase II dose Evaluate efficacy of HPN536 at the recommended Phase II dose
Inclusion Criteria
  • 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 2, Group 2 only) that is locally advanced, and now with progressive disease on or after frontline treatment
    • Malignant mesothelioma with epithelioid histology, pleural or primary peritoneal (Part 2, Group 3 only) that is progressive disease following frontline platinum-based chemotherapy
  • 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 ≥50 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 ≥30 mg/mL
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
  • History of or known or suspected autoimmune disease
  • History of clinically significant cardiovascular disease
  • Second primary malignancy that has not been in remission for greater than 3 years
  • Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT03872206

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Re: MC# 19-21