A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma

Overview

An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma.

SparkCures ID 1056
Trial Phase Phase 1/2
Enrollment 70 Patients
Treatments
Tags
Trial Sponsors
  • Harpoon Therapeutics
NCT Identifier

NCT04184050

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Major Inclusion Criteria:

  1. 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).
  2. Measurable disease defined as at least one of the following:
    1. Serum M-protein ≥0.5 g/dL
    2. Urine M-protein ≥200 mg/24 hours
    3. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L)
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  4. Adequate hematologic status, including:
    1. Absolute neutrophil count (ANC) ≥1000 cells/μL
    2. Platelet count ≥50,000/μL (without transfusions)
    3. Hemoglobin ≥8 g/dL
  5. Adequate renal function, including:
    1. Calculated creatinine clearance ≥30 mL/min using the formula of Cockcroft and Gault
  6. Adequate hepatic function, including
    1. Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct bilirubin
    2. AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement)
    3. Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement)

Major Exclusion Criteria:

  1. Prior exposure to BCMA-targeting agents (Part 2 only)
  2. 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Arizona
Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Colorado
Oregon
Washington

Resources

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