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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-020729-42
    Sponsor's Protocol Code Number:LDOS002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-19
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-020729-42
    A.3Full title of the trial
    A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47 as a Monotherapy in Non-Squamous Non-Small Cell Lung Cancer Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the safety of a new drug to treat non-squamous non-small cell lung cancer
    A.4.1Sponsor's protocol code numberLDOS002
    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 SponsorHelix BioPharma Corp
    B.1.3.4CountryCanada
    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 supportHelix BioPharma Corp.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelix BioPharma Corp.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address3-305 Industrial Parkway South
    B.5.3.2Town/ cityAurora
    B.5.3.3Post codeL4G 6X7
    B.5.3.4CountryCanada
    B.5.4Telephone number+1 905-841-2300282
    B.5.5Fax number+1 905-841-2244
    B.5.6E-mailsdemas@helixbiopharma.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 nameLyophilised L-DOS47
    D.3.2Product code L-DOS47
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLyophilised L-DOS47
    D.3.9.2Current sponsor codeL-DOS47
    D.3.9.3Other descriptive nameAFAIKL2-urease immunoconjugate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.7
    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 Yes
    D.3.11.13.1Other medicinal product typeimmunoconjugate of recombinant single chain antibody molecules AFAIKL2 against carcinoembryonic antigen related cell adhesion molecule 6 (CEACAM6-A), cross-linked with a purified Jack-Bean urease
    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
    Inoperable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Non-squamous non-small cell lung cancer that cannot be operated on, is locally advanced, has spread to other areas of the body or has returned after previous treatment.
    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 PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I
    - To define the maximum tolerated doses of multiple doses of L-DOS47 administered intravenously to patients with non-squamous non-small cell lung cancer when given as monotherapy.
    Phase II
    - To make a preliminary assessment of the efficacy of L-DOS47 in patients with non-squamous non-small cell lung cancer.
    E.2.2Secondary objectives of the trial
    Phase I and Phase II
    - To evaluate the pharmacokinetics of L-DOS47 in patients with non-squamous non-small cell lung cancer.
    - To evaluate the immunogenicity of L-DOS47 in patients with non-squamous non-small cell lung cancer
    - To evaluate the safety and tolerability of multiple doses of L-DOS47 in patients with non-squamous non-small cell lung cancer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged ≥ 18 years old
    2. Have histologically confirmed non-squamous NSCLC. (If available at the site, the paraffin-fixed biopsy sample will be provided to the Sponsor.)
    3. Have at least a single measurable lesion in accordance with the RECIST v1.1 criteria
    4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 5. Have a life expectancy of ≥ 3 months
    6. Have adequate organ function as determine by the following criteria:
    a. Absolute neutrophil count ≥ 1.5 x 1000000000/L
    b. Platelet count ≥ 100 x 1000000000/L
    c. Haemoglobin (HGB) ≥ 9 g/dL
    d. Creatinine clearance ≥ 60 mL/min calculated using the Cockcroft-Gault Formula or serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    e. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 x ULN, or < 5 x ULN if liver abnormalities are due to underlying malignancy
    f. Total bilirubin ≤ 1.5 x ULN.
    Note: Blood transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of L-DOS47 is administered are not allowed.
    7. Able to understand the information provided to them and to give written informed consent any study activities are conducted
    8. Are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
    9. Are not pregnant and do not plan to become pregnant during the study. Females of childbearing potential must provide a negative pregnancy test within the screening period (Day -21 to 0) and agree to use adequate contraception during the study and for a period of 90 days following the last dose of study treatment. Male patients and their female partners of child-bearing potential must agree to each use an approved form of contraception during the study and for a period of 90 days following the last dose. Adequate contraception includes oral or injectable (depot) oestrogen, and/or progestogen, or selective oestrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device or double barrier method (e.g., condom and diaphragm or spermicidal gel). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilisation or hysterectomy at least 3 months before study start.
    Pathway Specific Inclusion Criteria:
    Staging of non-squamous NSCLC must be assessed according to TNM, 7th edition and based on computed tomography (CT) scan.
    10. Patients are required to meet one of the following additional inclusion criteria:
    a. Chemo-naïve Stage IIIb or IV non-squamous NSCLC who are not candidates for radiotherapy or who refused standard therapy.
    b. Refractory Stage IIIb or IV non-squamous NSCLC.
    (Staging of non-squamous NSCLC must be assessed according to TNM, 7th edition and based on computed tomography (CT) scan.)
    E.4Principal exclusion criteria
    Patients will not be entered in the study for any of the following reasons:
    1. Are pregnant or nursing mother
    2. Have a prior history of other malignancies with the exception of non-melanoma skin cancer
    3.Have known history of central nervous system (CNS) metastatic disease (previously treated or untreated)
    4. Show evidence of active infection
    5. Have received treatment in another clinical study within the 30 days before commencing study treatment or have not recovered from side effects of a study drug, except for alopecia
    6. Have a serious uncontrolled medical condition
    7. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive
    8. Sustained QTc (the QT interval corrected for heart rate) with Fridericia's correction > 450 ms at Screening or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
    9. Pre-existing peripheral neurophathy ≥ CTC Grade 2
    10. Have dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol
    11. Are receiving chemotherapy during the 30 days before study start; receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start or have not recovered from all treatment related toxicities to Grade ≤ 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.)
    12. Are taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system
    13. Are participating (or planning to participate) in any other clinical trial during this study.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    - The incidence and severity of drug-related adverse events as per dose-limiting toxicity definition.

    Phase II
    - The overall response rate defined as the proportion of patients with a best (confirmed) objective response (RECIST v1.1) of complete response and partial response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: ≤ 3 weeks after start of treatment
    Phase II: End of treatment visit, or previous radiologic exam date if radiologic exam was performed < 6 weeks before the end of treatment visit
    E.5.2Secondary end point(s)
    a. L-DOS47-related toxicity during the first 2 hours after infusion, assessed by:
    i.Incidence and severity of AEs and SAEs
    ii.changes in vital signs
    b. Incidence and severity of AEs and SAEs
    c. Changes from Baseline in the following additional safety parameters: clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG
    d. Changes in physical examination
    e. The evaluation of anti-L-DOS47 antibody over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. 2 hours after start of infusion
    b. 30 days post last dose of study treatment
    c. D8, Day 15 of Cycle 4
    (end of Cycle 4) 7 days after last dose. Early Termination, Cycle 5 and beyond Days 1 & 8 predose
    d. D8 Day 15 of Cycle 4
    (end of Cycle 4) 7 days after last dose. Early Termination, Cycle 5 and beyond Days 1 & 8 predose,
    30 days post last dose of study treatment
    e. 30 days post last dose of study treatment
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability and immunogenicity
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of study is defined as 6 months after the last patient has been dosed or when all patients have discontinued, whichever is sooner.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 74
    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)
    Standard of care
    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 Decision2011-07-19
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-30
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