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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 4, 2022
Sponsor:
Information provided by (Responsible Party):
Harpoon Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 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

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 determined.
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




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



Information from the National Library of Medicine

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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. Patients ≥18 years of age at the time of signing informed consent
  2. Documented RRMM for which no standard therapy options are anticipated to result in a durable remission. Relapse defined as progressive disease after initial response (minimal response [MR] or better) to previous treatment, more than 60 days after cessation of last treatment. Refractory disease defined as <25% reduction in M protein or progression of disease during treatment or within 60 days after cessation of treatment.
  3. 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).
  4. 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) and an abnormal serum FLC ratio (<0.26 or >1.65)
  5. Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤1.

Major Exclusion Criteria:

  1. Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)
  2. Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.
  3. Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study
  4. Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded
  5. Last anticancer treatment within 2 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)

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


Contacts
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Contact: Harpoon Therapeutics (650) 452-7280 hpn217_3001ctgov@harpoontx.com

Locations
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Sponsors and Collaborators
Harpoon Therapeutics
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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 4, 2022
Last Verified: September 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