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    Summary
    EudraCT Number:2019-004793-26
    Sponsor's Protocol Code Number:HPN217-3001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2019-004793-26
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Open-label, Multicenter Study to evaluate the safety and tolerability of HPN217 in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    A.4.1Sponsor's protocol code numberHPN217-3001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04184050
    A.5.4Other Identifiers
    Name:INDNumber:141381
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHarpoon Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHarpoon Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHarpoon Therapeutics, Inc.
    B.5.2Functional name of contact pointLisa Knapp - Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address131 Oyster Point Blvd Suite 300
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016504527251
    B.5.6E-maillknapp@harpoontx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHPN217
    D.3.2Product code HPN217
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number Not assigned
    D.3.9.3Other descriptive nameHPN217
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/Refractory Multiple Myeloma (RRMM)
    E.1.1.1Medical condition in easily understood language
    Recurrent Multiple Myeloma that does not respond to treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives:
    • Assess safety and tolerability at increasing dose levels of HPN217 in successive cohorts of patients with RRMM
    • Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)
    • Characterize single dose and multiple dose pharmacokinetics (PK) of HPN217 following intravenous (IV) administration
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    • Evaluate preliminary efficacy of HPN217
    • Evaluate immunogenicity of HPN217

    Exploratory Objective:
    • Characterize the impact of HPN217 on soluble serum cytokines, including but not limited to interferon gamma (IFNγ), interleukin (IL)-6, tumor necrosis factor alpha (TNFα), and peripheral and bone marrow mononuclear cells
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion 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:
    a.S erum M-protein ≥0.5 g/dL
    b. Urine M-protein ≥200 mg/24 hours
    c. 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:
    a. Absolute neutrophil count (ANC) ≥1000 cells/μL
    b. Platelet count ≥50,000/μL (without transfusions)
    c. 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
    a. Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct bilirubin
    b. AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement)
    c. Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement)

    E.4Principal exclusion criteria
    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


    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    • Frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTCAE version 5.0.
    • Change from baseline in clinical laboratory parameters, vital signs, and ECGs.
    • Number and severity of DLTs following treatment with HPN217.
    • PK parameters of HPN217:
    o Single dose - maximum concentration (Cmax), time to maximum concentration (Tmax), area under the single dose concentration-time curve over dosing interval τ (AUCsd, τ), area under the concentration-time curve extrapolated to infinity (AUCinf), terminal elimination half-life (t1/2), and clearance (CL) as data permit
    o Multiple dose (assuming steady state is achieved) - maximum concentration (Css,max), time to maximum concentration (Tss,max), area under the steady state concentration-time curve over dosing interval τ (AUCss, τ), t1/2, minimum concentration (Css,min), CL, volume of distribution (Vss), and accumulation ratio (AUCss,τ/AUCsd, τ) as data permit
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation are outlined in Appendix 1 in the protocol
    Response evaluation is outlined in Appendix 3 in the protocol
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • Overall response rate (ORR) based on IMWG response criteria
    • Progression-free survival (PFS) and overall survival (OS)
    • Duration of response (DOR)
    • Incidence and titers of ADAs against HPN217
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation are outlined in Appendix 1 in the protocol
    Response evaluation is outlined in Appendix 3 in the protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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