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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

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ClinicalTrials.gov Identifier: NCT04184050
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Harpoon Therapeutics

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Multiple Myeloma in Relapse Multiple Myeloma Multiple Myeloma of Bone Multiple Myeloma With Failed Remission Drug: HPN217 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : January 2, 2024
Estimated Study Completion Date : June 2, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 (Dose Escalation)
HPN217 is IV administered 1x weekly for about 1 hour. Doses will vary between cohorts as MTD is being determine.
 Drug: HPN217
HPN217 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains
Experimental: Part 2 (Dose Expansion)
HPN217 is IV administered 1x weekly for about 1 hour. Doses will be determined from Part 1 (dose escalation)
 Drug: HPN217
HPN217 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of Adverse Events by CTCAE v5.0 of HPN217 [ Time Frame: 4 years ]
    Assess safety and tolerability at increasing dose levels of HPN217 in successive cohorts of patients with RRMM by way of adverse events (CTCAE v5.0)

  2. Determine MTD/ RP2D [ Time Frame: 2 years ]
    Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)

  3. Characterize Pharmacokinetics of Serum levels of HPN217 [ Time Frame: 2 years ]
    Characterize single dose and multiple dose pharmacokinetics (PK) of HPN217 following intravenous (IV) administration


Secondary Outcome Measures :
  1. Determine Efficacy by way of Disease Assessment using IMWG Response Criteria [ Time Frame: 4 years ]
    Evaluate preliminary efficacy of HPN217 by way of Disease Assessment using IMWG Response Criteria

  2. Determine Immunogenicity by way of Anti-drug Antibodies [ Time Frame: 4 years ]
    Evaluate immunogenicity of HPN217 by way of serum anti-drug antibodies being measured at different time points of the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    a. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184050


Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Lisa Bismarck, RN, MSN    480-256-5463    Lisa.Bismarck@bannerhealth.com   
Principal Investigator: Sumit Madan, MD         
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Joseph Maroge    858-246-0682    jmaroge@health.ucsd.edu   
Principal Investigator: Caitlin Costello, MD         
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: James Vick, MHA    720-754-4890    James.Vick@SarahCannon.com   
Principal Investigator: Henning Schade, MD         
United States, Kansas
The University of Kansas Cancer Center Recruiting
Fairway, Kansas, United States, 66205
Contact: Leah Miller, MS, CCRP    913-945-7538    lmiller25@kumc.edu   
Principal Investigator: Al-Ola Abdallah, MD         
United States, New York
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Contact: ct.gov Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Jens Hillengass, MD, PhD         
University of Rochester James P Wilmot Cancer Institute Recruiting
Rochester, New York, United States, 14642
Contact: Stephanie Short    585-276-7885    stephanie_short@urmc.rochester.edu   
Principal Investigator: Brea Lipe         
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Chris Seybold    503-494-9298    seyboldc@ohsu.edu   
Principal Investigator: Eva Medvedova, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Krystle Pagarian    206-386-2098    krystle.pagarigan@swedish.org   
Principal Investigator: William Bensigner, MD         
University of Washington - Seattle Cancer Center Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Erica Kalista    206-606-7099    ekalista@seattlecca.org   
Principal Investigator: Andrew Cowan, MD         
Spain
Clínica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Maite San Miguel    948 255 400 ext 2741    msanm.2@unav.es   
Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Recruiting
Madrid, Spain, 28040
Contact: Daniel Morillo, Dr.    +0034913908922    dmorillo@startmadrid.com   
Sponsors and Collaborators
Harpoon Therapeutics
More Information
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Responsible Party: Harpoon Therapeutics
ClinicalTrials.gov Identifier: NCT04184050    
Other Study ID Numbers: HPN217-3001
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases