Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 1/2a 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

Keywords

Advanced Cancers Associated With Mesothelin Expression Neoplasms HPN536

Eligibility

For people ages 18 years and up

  1. Patients ≥18 years of age
  2. One of the following progressive advanced or metastatic cancers:
  3. Epithelial ovarian, fallopian tube, or primary peritoneal cancer (Part 1 and Part 2, Group 1 only) that is platinum refractory or platinum resistant
  4. 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
  5. 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)
  6. 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
  7. Available archival tissue sample or fresh biopsy tissue sample must be obtained prior to enrollment
  8. 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
  9. ECOG performance status of 0 or 1
  10. Adequate bone marrow function, including:
  11. Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 x 109/L
  12. Platelets ≥100,000/mm3 or ≥100 x 109/L
  13. Hemoglobin (Hgb) ≥10 g/dL
  14. Adequate renal function, including estimated creatinine clearance ≥30 mL/min
  15. Adequate liver function, including:
  16. 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
  17. Aspartate and alanine transaminase (AST and ALT) ≤2.5 x ULN or AST/ALT ≤5 x ULN for patients with liver metastases
  18. . Serum albumin as follows:
  19. ≥30 mg/mL for patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or mesothelioma
  20. Within normal limits for patients with pancreatic adenocarcinoma
  21. . 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

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095-7170 United States
  • University of Southern California accepting new patients
    Los Angeles California 90007 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Harpoon Therapeutics
ID
NCT03872206
Phase
Phase 1/2
Study Type
Interventional
Last Updated