A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and PK of HPN217 in Patients With R/R MM

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
Enrollment 70 Patients
Treatments
Tags
Trial Sponsors
  • Harpoon Therapeutics
NCT Identifier

NCT04184050

CLOSED

This trial is active but is no longer accepting patients.

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

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Trial Links

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