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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:Completed
    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.5.3WHO Universal Trial Reference Number (UTRN)U1111-1261-6031
    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 pointKarin Thacker
    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 number0016507878960
    B.5.6E-mailkthacker@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
    1. Able to read, understand and provide written informed consent.
    2. Patients =18 years of age at the time of signing informed consent.
    3. 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.
    4. 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).
    5. Measurable disease defined as at least one of the following:
    a. Serum 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) and an abnormal serum FLC ratio (<0.26 or >1.65)
    6. Eastern Cooperative Oncology Group (ECOG) performance status =2.
    7. Adequate hematologic status, including:
    a. ANC =1000 cells/µL
    b. Platelet count =50,000/µL (without transfusions)
    c. Hemoglobin =8 g/dL
    Note: To meet all above hematological criteria (Inclusion Criteria 7a
    through 7c), transfusions and supportive therapy (e.g., granulocyte colony stimulating factors) may be administered prior to Screening.
    However, in all such instances, levels of the relevant parameters (for which the patient was transfused) must be allowed to stabilize for at least 72 hours after
    dosing/infusion, after which Screening labs may be redrawn.
    8. Adequate renal function, including:
    a. Calculated creatinine clearance =30 mL/min using the formula of Cockcroft and Gault
    9. Adequate liver function, including:
    a. Total bilirubin =1.5 × upper limit of normal (ULN), regardless of direct bilirubin
    b. Aspartate and alanine aminotransferase (AST and ALT) =3.0 × ULN (= 5.0× ULN if due to myeloma involvement)
    c. Alkaline phosphatase =3.0× ULN (=5.0× ULN if due to myeloma involvement)
    10. Serum calcium (corrected for albumin) at or below the ULN range; patient may enroll with hypercalcemia at Screening if hypercalcemia resolves with standard treatment by Cycle 1 Day 1, prior to study therapy initiation.
    11. Resolved acute effects of any prior therapy to baseline severity or CTCAE version 5.0 Grade =1.
    12. Willing to complete all scheduled visits and assessments at the institution administering therapy.
    E.4Principal 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 Inclusion Criterion 5 for measurable disease.
    3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
    4. Waldenstrom's macroglobulinemia
    5. Localized radiation therapy to disease site(s) within 2 weeks of treatment
    6. Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study
    7. Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded
    8. Prior corticosteroid use within <2 weeks of treatment, with the exception of topical or temporary use (=20 mg/day for no more than 5 days total), which may be allowed after approval by the CRO Medical Monitor
    9. Known central nervous system involvement by multiple myeloma
    10. Untreated spinal cord compression
    11. Concurrent treatment with anti-TNFa therapies, or other immune
    suppressive drugs within the 2 weeks prior to Screening
    12. History of clinically significant cardiovascular disease, unstable angina pectoris, recent myocardial infarction, congestive heart failure, uncontrolled cardiac arrhythmia, history of cerebral vascular accident, transient ischemic attack, or other co-morbid condition that in the opinion of the investigator would compromise the patient's safety or interfere with the evaluation of the safety of HPN217. Participants with cardiovascular disease that is stable for at least 6 months while on
    treatment may be enrolled after documenting evaluation and approval of trial participation by a cardiologist.
    13. Known congestive heart failure (New York Heart Association Class 3)
    14. History of any thromboembolic event within 3 months prior to first dose of HPN217
    15. Active infectious disease requiring treatment within 2 weeks of Screening
    16. Active or chronic hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
    17. Clinically active or chronic liver disease, including liver cirrhosis of Child-Pugh class C
    18. Other malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy)
    19. Last anticancer treatment within 2 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)
    20. Major surgery within 4 weeks of scheduled dosing
    21. Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements
    22. Any serious underlying medical or psychiatric condition (e.g., alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the Investigator would contraindicate the patient's participation in the study or confound the results of the study
    23. Known hypersensitivity, allergies, or intolerance to immunoglobulins, or to any excipient contained in HPN217 (see Investigator's Brochure)
    24. Treatment with another investigational drug within 4 weeks before start of study treatment or concomitantly with this study
    25. Patient has unresolved AEs =Grade 2 (National Cancer Institute [NCI] CTCAE version 5.0) except for:
    a. Alopecia
    b. Known peripheral neuropathy (peripheral neuropathy =Grade 3 will be excluded)
    c. Patient with irreversible toxicity not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss) after consultation with the Medical Monitor
    26. Pregnant or breast-feeding
    27. Women of childbearing potential not using a highly effective method of birth control during the study until 6 months after the last dose of HPN217. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., <1% per year) when used consistently and correctly (including implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or vasectomized partner; barrier methods of contraception are accepted if condom or occlusive cap is used together with spermicides [e.g., foam, gel]) and a highly effective method of birth control. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or postmenopausal (12 months with no menses without an alternative medical cause)
    28. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the study and for a minimum of 6 months after treatment
    29. For Part 2 (Expansion) only – Patients with prior exposure to BCMA targeting
    agents
    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 and response evaluation are outlined in Appendix 1,2 and 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 and response evaluation are outlined in Appendix 1,2 and 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 Yes
    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 EEA13
    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
    Germany
    Italy
    Spain
    United States
    France
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 80
    F.4.2.2In the whole clinical trial 114
    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 Opinion2021-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
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