A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relaped/Refractory Multiple Myeloma

Overview

About this study

The purpose of this study is to evaluate HPN217 as monotherapy to assess the safety, tolerability and pharmacokinetics in patients with relapsed/ refractory multiple myeloma.

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:

  • Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
  • Measurable disease defined as at least one of the following:
    • Serum M-protein ≥ 0.5 g/dL;
    • Urine M-protein ≥ 200 mg/24 hours;
    • Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥ 100 mg/L).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Adequate hematologic status, including:
    • Absolute neutrophil count (ANC) ≥ 1000 cells/μL;
    • Platelet count ≥ 50,000/μL (without transfusions);
    • Hemoglobin ≥ 8 g/dL.
  • Adequate renal function, including:
    • Calculated creatinine clearance ≥ 30 mL/min using the formula of Cockcroft and Gault.
  • Adequate hepatic function, including:
    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN), regardless of direct bilirubin;
    • AST and ALT ≤ 3.0 × ULN (≤ 5.0× ULN if due to myeloma involvement);
    • Alkaline phosphatase ≤ 3× ULN (≤ 5.0× ULN if due to myeloma involvement).

Exclusion Criteria:

  • Prior exposure to BCMA-targeting agents (Part 2 only).
  • Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening.

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Peter Bergsagel, 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-20507823

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