Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-000151-40
    Sponsor's Protocol Code Number:SGM-CLIN03
    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:2019-01-02
    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 number2018-000151-40
    A.3Full title of the trial
    Multicenter, semi-blinded, randomized, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fluorescence for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer.
    A.4.1Sponsor's protocol code numberSGM-CLIN03
    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 SponsorSurgimab
    B.1.3.4CountryFrance
    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 supportSurgimab
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSurgimab
    B.5.2Functional name of contact pointFrançoise Cailler
    B.5.3 Address:
    B.5.3.1Street Address10, Parc Club du Millénaire; 1025, avenue Henri Becquerel
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467798381
    B.5.6E-mailfcailler@surgimab.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 namefluorochrome-labeled anti-carcino-embryonic antigen
    D.3.2Product code SGM-101
    D.3.4Pharmaceutical form 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 INNSGM-101
    D.3.9.2Current sponsor codeSGM-101
    D.3.9.4EV Substance CodeSUB182708
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    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
    Patients undergoing curative surgery for colorectal cancer
    E.1.1.1Medical condition in easily understood language
    colorectal cancer
    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 PT
    E.1.2Classification code 10010030
    E.1.2Term Colorectal cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10010035
    E.1.2Term Colorectal cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10010034
    E.1.2Term Colorectal cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    To analyze the clinical benefit
    resulting from the use of
    Fluorescence Guided Surgery (FGS)
    during the surgical procedure, with
    SGM-101 as the intraoperative
    imaging agent, in terms of additional
    cancer lesions detected with the goal
    to achieving R0 resection
    E.2.2Secondary objectives of the trial
    1. To analyze the clinical benefit resulting from the use of FGS during the surgical procedure, with SGM-101 as the intraoperative imaging agent
    2. To analyze the false detection rate of FGS during the surgical procedure, with SGM-101 as the intraoperative imaging agent.
    3. To analyze the clinical benefit resulting from the use of FGS during the surgical procedure, with SGM-101 as the intraoperative imaging agent, in terms of overall benefit.
    4. Analyze the benefit (observed or potential)
    5. Diagnostic performance of FGS: Sensitivity
    6.Diagnostic performance of FGS: False Positive Rate (FPR)
    7. To further characterize diagnostic performance by analyzing the PPV, NPV, Specificity & Accuracy of FGS.
    8. Diagnostic performance of FGS versus fresh frozen sections.
    9. To describe the TBR
    10. To document the impact of SGM-101 injection on the surgical procedure
    11. To evaluate tolerability/safety of SGM-101 injection
    12. To evaluate short term surgical outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged over 18 years old;

    2. Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer;

    3. Female patients should not be of childbearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal) nor breastfeeding. Women of child-bearing potential, including women who have a documented tubal ligation, will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception (highly effective methods as listed in Section 5.1) for 30 days prior to administration of investigational product, and 90 days after completion of injection.

    A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;

    4. Patients should be capable and willing to give informed consent before study specific procedures.
    E.4Principal exclusion criteria
    1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
    2. Primary appendiceal cancer;
    3. Laboratory abnormalities defined as:
    - Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
    - Total bilirubin above 2 times the ULN or;
    - Serum creatinine above 1.5 times the ULN or;
    - Platelet count below 100 x 109/L or;
    - Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
    4. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
    5. Use of another investigational drug during 4 weeks before the Injection Day.
    6. Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    Detection rate: E1

    Proportion of patients in whom NIR allowed to:
    1. achieve tumor free surgical margins of lesions identified before the use of NIR,when WL did not (R0 resection)
    AND/OR

    2. identify and resect at least one additional true positive (TP) tumor lesion in patients in which WL allowed to achieve tumor free margins for all lesions identified before the use of NIR AND/OR

    3. identify and resect at least one additional true positive (TP) tumor lesion in patients undergoing a debulking surgery before a HIPEC procedure.

    The three individual components of E1 (E1.1 , E1.2
    and E1.3) will also be analyzed separately
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day of the surgery
    E.5.2Secondary end point(s)
    1. “Conservative surgery benefit” rate: E2 Proportion of patients who have more [WL positive, NIR negative, pathology negative
    lesions] (NIR true negatives) than [WL negative, NIR positive, pathology negative] (NIR false positive) lesions, i.e. a net benefit
    in numbers of negative lesions wrongly resected.

    2. False detection rate: E3
    Proportion of patients who have all additional biopsies / resections under NIR that are false positives (FP).

    3. Composite endpoint at the patient level:
    Clinical benefit (or “positive” change in surgery plan or post-surgical management of the patient resulting from the use of FGS)
    rate E4.
    Clinical benefit will be assessed within each patient by comparing standard of care surgery without fluorescence to surgery with
    fluorescence and assessing if the latter allowed to remove any additional pathologically confirmed malignant lesion and/or to resect less nonmalignant tissue, and/or to adapt the post-surgical
    management in case of detection with NIR only of unsuspected new lesions, leading to a re-staging of the disease, each patient serving as his own control. The outcome measure will be the rate of
    patients with clinical benefit.

    4. Composite endpoint at the patient level: Rate of Fluorescence Guided Surgery benefit over White Light alone: E5.
    At the individual lesion level, all FGS vs WL discordant results are reviewed to evaluate which of FGS or WL agrees with pathology results. If FGS is consistent with pathology the FGS has a positive outcome. When FGS is discordant with pathology then it has a negative outcome. All concordant FGS and WL results are considered as neutral (neither benefit nor harm from FGS over WL). Lesions with FGS and WL concordant results will receive a neutral assessment.
    At the patient level, if the number of individual lesion positive results is greater than the number of individual lesion negative results, the overall result will be considered as positive. It will be considered as negative in all other cases (greater number of individual lesions negative outcome, equal numbers of negative and positive individual lesions outcomes or only neutral individual lesion outcomes).

    5. Sensitivity rate E6: The accuracysensitivity rate will be used as the main endpoint to assess intraoperative imaging agent performance.
    The statistical analysis will consist in describing the concordance between FGS using SGM-101 as intraoperative imaging agent and the pathology results (final pathology when available or FFS if not sent to pathology) with respect to the presence of cancer using rates of true positives (TP), false positives (FP), false negatives (FN), true negatives (TN) and the accuracy rate (TP+TN). The sensitivity (Se) ratio (malignant results correctly identified by fluorescence) will be computed as the ratio of true positives over the sum of true positives + false negatives: Se=TP/(TP+FN)

    6. False Positive Rate: E7
    The FPR (non malignant lesions wrongly identified by fluorescence as malignant) is equal to 1-the Positive Predictive Value (PPV). It will be computed as the ratio of false positives over the sum of true positives + false positives: FPR = (1-PPV) = FP/(TP+FP).

    7. •Positive Predictive value (PPV) (percentage of histologically (final pathology when available or FFS if not sent to pathology) positive lesions among fluorescent lesions),
    •Negative Predictive value (NPV) (percentage of histologically (final pathology
    when available or FFS if not sent to pathology) negative lesions among nonfluorescent lesions),
    •Specificity ratio (Sp) (non-malignant results correctly identified by fluorescence).
    •Accuracy: percentage of accurate identification by NIR (TP and TN) as
    confirmed by histologically (final pathology when available or FFS if not sent to
    pathology).

    8. The diagnostic performance of FGS will be analyzed on the subgroup of patients with fresh frozen sections taken during surgery, to assess if FGS could replace fresh frozen sections, resulting in a potential benefit on the total duration of the surgical procedure.

    9. Computation of descriptive statistics for TBR, defined as fluorescent signal of tumor tissue compared to fluorescence signal of normal tissue surrounding the tumor.

    10. Assessment of the impact of SGM-101 injection on the surgical procedure (rapidity of the evaluation, easiness of detection of additional nodules, duration of surgical procedure, duration of anesthesia) with the surgeon’s questionnaire

    11. Routine clinical measurements such as treatment-emergent adverse events, blood pressure, heart rate, temperature, peripheral oxygen saturation, respiratory rate, skin examination, and routine laboratory assessments.

    12. Assessment of adverse events related to surgery within a period of 32 days following SGM-101 injection in order to substantiate the benefit/risk assessment of the use of SGM-101 and assess a possible bias in the surgeons’ approach due to the use of fluorescence.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint # 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 = Day of the surgery

    Endpoint # 11 and 12: From SGM-101 injection to 28 days after surgery
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    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) No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Semi Blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Saline injection followed by standard surgical treatment
    E.8.2.4Number of treatment arms in the trial2
    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 EEA5
    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
    Italy
    Netherlands
    E.8.7Trial has a data monitoring committee Yes
    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
    last visit of the last subject undergoing the trial
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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 Decision2019-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 09 02:49:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA