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    Summary
    EudraCT Number:2007-004888-22
    Sponsor's Protocol Code Number:CHCD122A2103
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-08
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2007-004888-22
    A.3Full title of the trial
    A phase IA/II, multi-center, open-label study of HCD122 administered intravenously once weekly for four weeks in adult patients with advanced non-Hodgkin's or Hodgkin's lymphoma who have progressed after at leastr two prior therapies
    A.3.2Name or abbreviated title of the trial where available
    CHCD122A2103
    A.4.1Sponsor's protocol code numberCHCD122A2103
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameHCD122
    D.3.2Product code 7006601
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHCD122
    D.3.9.3Other descriptive nameRecombinant fully human monoclonal antibody directed against human CD40
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Advanced non Hodgkin's or Hodgkin's lymphoma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose escalation phase
    Primary objective:
    1.To determine the maximum tolerated dose (MTD) or the recommended Phase II dose of HCD122 when administered as a single agent intravenously (IV) once weekly for 4 weeks to adult patients with advanced non-Hodgkin’s or Hodgkin’s lymphoma who have progressed after at least two prior therapies

    Dose expansion phase
    Primary objective:
    1.To assess clinical response at the MTD or the recommended phase II dose in adult patients with advanced non-Hodgkin’s or Hodgkin’s lymphoma who have progressed after at least two prior therapies
    E.2.2Secondary objectives of the trial
    Dose escalation phase:
    Main Secondary objective:
    1.To characterize safety and tolerability of single agent HCD122, including acute and chronic toxicities
    2.To characterize the pharmacokinetic (PK) profile after single and repeated doses of single agent HCD122 on a once weekly dosing schedule for 4 weeks
    3.To assess the immunogenicity of HCD122
    4.To characterize the CD40 occupancy profile of HCD122 on peripheral CD19(+) B cells after single and repeated doses

    Dose expansion phase:
    Main Secondary objectives:
    1.To characterize safety and tolerability of single agent HCD122, including acute and chronic toxicities
    2.To characterize the pharmacokinetic (PK) profile after single and repeated doses of single agent HCD122 on a once weekly dosing schedule for 4 weeks for the first 40 patients in dose expansion phase
    3.To assess the immunogenicity of HCD122
    4.To characterize the CD40 occupancy profile of HCD122 on peripheral CD19(+) B cells after single and repeated doses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients must have confirmed diagnosis, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification, of the following B-cell lymphomas:
    1.Follicular lymphoma (FL)
    2.Marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT)
    3.Diffuse large B-cell lymphoma (DLBCL)
    4.Mantle cell lymphoma (MCL), OR
    5.Hodgkin lymphoma (HL)
    •Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy):
    1.Patient must receive at least one prior therapy with a rituximab containing regimen if it is indicated as the standard of care
    2.If patient received autologous stem cell transplantation, patient must have received at least 1 prior systemic therapy
    3.If patient did not receive autologous stem cell transplantation, patient must have received at least 2 prior systemic therapies
    •Patients who received autologous stem cell transplantation:
    1.Must be at least 12 weeks post-transplant prior to study drug, AND
    2.Must have recovered fully from the side effects of such treatment prior to beginning study treatment.
    •Patients who have NOT received autologous stem cell transplantation:
    1.Must be ineligible for the autologous stem cell transplantation, OR
    2.If eligible, patients chose not to receive stem cell transplant
    •Patients must have discontinued any previous anticancer and investigational therapy including radiation therapy for at least 21 days prior to study drug, and must have recovered fully from the side effects of such treatment prior to beginning study drug.
    •Patients must have discontinued previous monoclonal antibody (except rituximab) or radioimmunotherapy administration for at least 60 days prior to study drug, and are confirmed either have no response to that therapy or have disease progression after the treatment. Patients must have recovered fully from the side effects of that treatment prior to beginning study treatment.
    For patients who received rituximab containing regimen, rituximab should be
    discontinued for at least 28 days prior to study drug, are confirmed to either have no
    response or have disease progression after rituximab treatment, and must have
    recovered fully from the side effects of such treatment prior to beginning study drug.
    •Patients must not have undergone major surgery within 30 days prior to study drug, and must have recovered fully from the side effects of any major or minor surgical procedures prior to study treatment.
    •Patients must be ≥ 18 years
    E.4Principal exclusion criteria
    •Patients who have been treated with any anti-CD40 antibody
    •Patients who have received prior allogeneic stem cell transplant
    •Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
    •Patients who are taking systemic corticosteroids, except for a dose up to 100 mg of hydrocortisone or equivalent as premedication administered prior to certain medications or blood products
    •Patients who have current drug or alcohol abuse
    •Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
    •Impaired cardiac function or clinically significant cardiac disease, including any one of the following:
    1.New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant arrhythmia, congestive heart failure, or cardiomyopathy
    2.Angina pectoris ≤ 3 months prior to starting study drug
    3.Acute MI ≤ 3 months prior to starting study drug
    4.Other clinically significant heart disease (e.g., uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
    •Patients who have history of pancreatic disease (e.g., acute or chronic pancreatitis, etc.) or any surgery of the pancreas
    •Patients who have gallbladder stone, cystic fibrosis, or any other risk factors that may increase the risk of pancreatitis
    •Patients who have history of active infection (viral, bacterial, or fungal) requiring systemic therapy within 4 weeks prior to enrollment. Prophylactic antibiotics and anti-viral therapies are permitted
    E.5 End points
    E.5.1Primary end point(s)
    Dose escalation phase:
    Incidence rate of dose-limiting toxicity (DLT)

    Dose expansion phase:
    Response rate according to the 2007 Cheson criteria
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    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 No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Study completion is defined as participation in the study through week 16 (day 106) and completion of the week 16 (day 106) study visit. Discontinuation prior to this time point constitutes early discontinuation from the study ( for details see protocol Section 6.6.12).
    At week 16 (day 106), patients showing a best disease response of stable disease or achieve a response (PR or CR) during the study will have the option of retreatment with HCD122.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-09-08. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 230
    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 Decision2009-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-06
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