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

Overview

About this study

To assess the safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 front-line 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/mm^3 or ≥ 1.5 x 10^9/L;
      • Platelets ≥ 100,000/mm3 or ≥ 100 x 10^9/L;
      • Hemoglobin (Hgb) ≥ 0 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Gerardo Colon-Otero, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Andrea Wahner Hendrickson, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20473923

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