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

What's the purpose of this trial?

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

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1/2

Enrollment: 114 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Open and Accepting

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

Moores Cancer Center UC San Diego Health

La Jolla, CA

Open and Accepting

Colorado

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

New York

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Open and Accepting

Oregon

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Open and Accepting

Washington

Swedish - Cherry Hill Campus Cherry Hill Campus

Seattle, WA

Open and Accepting

Trial Links

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