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    Summary
    EudraCT Number:2018-000444-26
    Sponsor's Protocol Code Number:17-BI-1206-02
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-11-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-000444-26
    A.3Full title of the trial
    Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early phase clinical trial testing a new antibody (BI-1206) for use with rituximab in patients with slow-growing types of Non-Hodgkin Lymphoma that has not responded to or has returned after previous treatment with rituximab
    A.4.1Sponsor's protocol code number17-BI-1206-02
    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 SponsorBioInvent International AB
    B.1.3.4CountrySweden
    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 supportBioInvent International AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioInvent International AB
    B.5.2Functional name of contact pointSuzanne Kilany
    B.5.3 Address:
    B.5.3.1Street AddressIdeongatan 1
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-223 70
    B.5.3.4CountrySweden
    B.5.4Telephone number+46708591816
    B.5.5Fax number+462110806
    B.5.6E-mailsuzanne.kilany@bioinvent.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 nameBI-1206
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNFully human immunoglobulin G1 (IgG1) monoclonal antibody
    D.3.9.2Current sponsor code17-BI-1206-02
    D.3.9.3Other descriptive nameFully human immunoglobulin G1 (IgG1) monoclonal antibody
    D.3.9.4EV Substance CodeSUB181697
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Indolent B-Cell Non-Hodgkin Lymphoma
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin Lymphoma (cancer)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Assess the safety and tolerability profile of BI-1206 when administered in combination with rituximab in subjects with indolent relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
    • Select the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via intravenous infusion in combination with rituximab.
    E.2.2Secondary objectives of the trial
    • Study the pharmacokinetic (PK) profile of BI-1206 when administered in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL.
    • Study the PK profile of rituximab when administered in combination with BI-1206.
    • Assess the immunogenicity of BI-1206 when administered in combination with rituximab.
    • Evaluate the effect of BI-1206 administered in combination with rituximab on the depletion of B-cells.
    • Assess possible anti-tumor activity of BI-1206 administered in combination with rituximab at Week 6 after first dose of BI-1206 and for subjects who continue during maintenance therapy.
    • Investigate CD32b protein expression levels; evaluate any potential correlation with clinical responses.
    • Perform whole-transcriptome analysis of lymph node biopsies; evaluate any potential correlation with clinical responses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are ≥ 18 years of age by initiation of study treatment.
    2. Provide written (signed and dated) informed consent.
    3. Are capable of cooperating with treatment and follow-up.
    4. Have B-cell NHL proven by histology, with histological subtypes limited to FL (except FL3B), MCL and MZL.
    5. Have measurable nodal disease, defined as the presence of ≥1 nodal lesion that measures ≥1.5 cm in a single dimension as assessed by computerized tomography (CT) or magnetic resonance imaging (MRI).
    6. Are willing to undergo lymph node biopsies or biopsies of other involved tissue (besides bone marrow). However, if a biopsy is not technically feasible, the sample can be omitted. If viable frozen tissue (not formalin-fixed) from a previous standard of care biopsy in the previous 8 weeks prior to consent is available, a new biopsy at screening is not required.
    7. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists, the investigator judges available standard therapy as not being appropriate for the subject, or is declined by the subject. Rituximab refractory disease is defined as:
    • Lack of CR or PR during rituximab-containing treatment comprising ≥2 doses of ≥375 mg/m2, or
    • Occurrence of progressive disease after completion of a regimen of rituximab-containing therapy comprising ≥2 doses of ≥375 mg/m2, or
    • Occurrence of progressive disease during rituximab maintenance therapy or within 6 months of completion of rituximab maintenance therapy.
    8. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen.
    9. Have a life expectancy of at least 12 weeks on the day of the first infusion of BI-1206.
    10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2.
    11. Have CD20+ malignancy as demonstrated by IHC or flow cytometry prior to first dose of BI-1206. Analysis must have been performed on the most recent biopsy obtained and must be after anti-CD20 therapy.
    12. Have hematological and biochemical indices within prespecified ranges, including hemoglobin (≥9.0 g/dL, red cell support is permissible); absolute neutrophil count (ANC) (≥1.0 × 109/L, or >0.5 × 109/L if due to lymphoma; granulocyte-colony stimulating factor support is not permissible at screening); and platelet count (≥100 × 109/L). These measurements must be performed within 1 week and assessed by the Investigator before their first dose of BI-1206.
    E.4Principal exclusion criteria
    1. Have had an allogenic bone marrow or stem cell transplant within 12 months prior to the first dose of BI-1206.
    2. Have presence of active chronic graft versus host disease of any grade/severity.
    3. Have current leptomeningeal lymphoma or compromise of the central nervous system.
    4. Have transformed lymphoma from a pre-existing indolent lymphoma. Subjects with a previous history of transformation, but on this disease episode have a biopsy proven indolent recurrence, may be included. Subjects with proven or suspected Richter transformation are not eligible.
    5. Have Waldenstrom’s Macroglobulinemia or FL3B, due to the high risk of transformation while on study.
    6. Need systemic doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the study other than as pre-medication. During the screening period, doses of up to 20 mg/day may be given but the dose must be reduced to 10 mg/day within 7 days prior the first dose of study drug. Inhaled or intranasal steroids are permissible.
    7. Have known or suspected hypersensitivity to rituximab or BI-1206. Previous isolated IRRs are not to be considered a reason for exclusion.
    8. Have cardiac or renal amyloid light-chain amyloidosis.
    9. Have received any of the following:
    • Chemotherapy or small molecule products with 2 weeks of first dose of BI- 1206 and/or
    • Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks of first dose of BI-1206 and/or
    • Immunotherapy within 8 weeks prior to the first dose of BI-1206.
    10. Have ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator should not exclude the subject.
    11.Have the ability to become pregnant (or already pregnant or lactating/breastfeeding). However, those female subjects who have a negative serum pregnancy test before enrollment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial and for 12 months after last dose of BI 1206 are considered eligible. Highly effective methods of birth control include:
    • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation
    • Progestogen-only hormonal contraception associated with inhibition of ovulation
    • Intrauterine device
    • Intrauterine hormone-releasing system
    • Bilateral tubal occlusion
    • Vasectomized partner
    • Sexual abstinence
    12. Are male subjects with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception (condom plus spermicide gel) during the trial and for 12 months after completing treatment). Men with pregnant or lactating partners should be advised to use barrier method contraception (condom plus spermicidal gel) to prevent exposure to the fetus or neonate.
    13. Have had major surgery from which the subject has not yet recovered.
    14. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.
    15. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
    16. Have an active, known or suspected autoimmune disease. However, subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia not requiring systemic treatment), or conditions not expected to recur in the absence of an external trigger will be permitted to participate.
    17. Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), history of clinically significant cardiac ischemia or cardiac arrhythmia in the past 6 months.
    18. Have ongoing alcohol or drug addiction, as judged by the Investigator.
    19. Have any other condition which in the Investigator’s opinion would not make the subject a good candidate for the clinical trial.
    20. Are participating or plan to participate in another interventional clinical study, while taking part in this Phase 1/2a study of BI-1206. Participation in an observational non-interventional study is acceptable.
    21. Have current malignancies of other types, with the exception of:
    • adequately treated cone-biopsied in situ carcinoma of the cervix uteri
    • basal or squamous cell carcinoma of the skin
    • asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of study therapy.

    Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for ≥ 3 years and are deemed at negligible risk for recurrence, are also eligible for the trial.
    E.5 End points
    E.5.1Primary end point(s)
    • Documenting AEs and SAEs (graded according to National Cancer Institute [NCI] CTCAE version 4.03), including IRRs, and determining causality in relation to BI 1206 and/or rituximab. Causality of AEs/SAEs will be assessed by the Investigator.
    • Determining the MTD of BI-1206, with no more than 1 of up to 6 subjects at the same dose level experiencing DLT during the 28-day treatment period on induction therapy (i.e., by Day 29/Week 5). If pharmacokinetic (PK) and pharmacodynamic (PD) data suggest an optimal therapeutic dose, the escalation may be halted by the Cohort Review Committee (CRC) prior to reaching the MTD, and the RP2D will be based off the PK and PD data.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At prespecified time points throughout the trial.
    E.5.2Secondary end point(s)
    • Evaluation of PK parameters for BI-1206 during the BI-1206 treatment period.
    • Evaluation of PK parameters for rituximab during the BI-1206 treatment period.
    • Evaluation of ADA response to BI 1206.
    • Measurement of B cell depletion.
    • Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014). Other endpoints will include time to objective response, duration of response, PFS, and OS.
    • CD32b protein expression levels.
    • Expression levels of CD32b and/or other immunological markers.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At prespecified time points throughout the trial.
    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 Yes
    E.6.10Pharmacogenetic Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1/2a
    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 Yes
    E.8.1.7.1Other trial design description
    Dose escalation, consecutive-cohort
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Belgium
    Poland
    Spain
    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 years1
    E.8.9.1In the Member State concerned months7
    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 months0
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 52
    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)
    For all subjects, the study will have 2 Off-treatment Follow-up (OTFU) visits to monitor PK and anti-drug antibody (ADA). Additionally, the OTFU 1 visit will include safety assessments for subjects who receive maintenance therapy. These visits will occur approximately 56 days and 84 days, respectively, after last dose of BI-1206.
    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 Decision2018-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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