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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2023-000171-13
    Sponsor's Protocol Code Number:P23
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-03-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2023-000171-13
    A.3Full title of the trial
    SGM-101 tumor-targeted fluorescence endoscopy to enable discrimination of malignant from benign tissue in rectal polyps with suspected T1 adenocarcinoma or high grade dysplasia: a feasibility study
    SGM-101 tumor-gerichte fluorescentie-endoscopie om kwaadaardig van goedaardig weefsel te kunnen onderscheiden in rectale poliepen met vermoedelijk T1 adenocarcinoom of hooggradige dysplasie: een haalbaarheidsstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Discriminating malignant from benign tissue in rectal polyps with the help of the fluorescent probe SGM-101
    Onderscheid tussen kwaadaardig en goedaardig weefsel in rectale poliepen met behulp van de fluorescerende stof SGM-101
    A.3.2Name or abbreviated title of the trial where available
    SGM-T1
    SGM-T1
    A.4.1Sponsor's protocol code numberP23
    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 Sponsorleiden university medical center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointDenise Hilling
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715264005
    B.5.6E-maild.e.hilling@lumc.nl
    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 anticarcinoembryonic antigen
    D.3.2Product code SGM-101
    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 INNSGM-101
    D.3.9.3Other descriptive nameChimeric monoclonal antibody against carcinoembryonic antigen conjugated to fluorochrome BM-104
    D.3.9.4EV Substance CodeSUB294627
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Early rectal cancer/ big polyps with suspected T1 rectal cancer.
    Vroegstadium endeldarmkanker / endeldarmpoliep verdacht om ook een T1-component te bezitten.
    E.1.1.1Medical condition in easily understood language
    Rectal polyp with suspected rectal cancer
    endeldarmpoliep met een plekje verdacht voor kanker
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10038074
    E.1.2Term Rectal polyp
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to investigate the feasibility of a tumour-targeted fluorescent tracer SGM-101, combined with the use of the CE-marked fluorescence-laparoscope of Quest Medical Imaging, to discriminate between normal, LGD and malignant tissue (HGD, T1RC) in patients with suspected T1/HGD rectal cancer.
    It consists of two phases for which primary objectives are defined separately:
    Phase I: Dose optimization phase to determine the optimal dose of SGM-101
    Phase II: feasibility assessment of tumor-targeted fluorescence endoscopy with the use of SGM-101 in discriminating normal, LGD and malignant tissue (HGD, T1RC).
    Het hoofddoel is de haalbaarheid te onderzoeken van een tumor-gerichte fluorescerende tracer SGM-101, gecombineerd met het gebruik van de CE-gemarkeerde fluorescentie-laparoscoop van Quest Medical Imaging, om onderscheid te maken tussen normaal, LGD en kwaadaardig weefsel (HGD, T1RC) bij patiënten met vermoedelijke T1/HGD rectumkanker.
    Het bestaat uit twee fasen waarvoor de primaire doelstellingen afzonderlijk worden gedefinieerd:
    Fase I: Dosisoptimalisatiefase om de optimale dosis van SGM-101 te bepalen
    Fase II: beoordeling van de haalbaarheid van tumorgerichte fluorescentie-endoscopie met het gebruik van SGM-101 bij het onderscheiden van normaal, LGD en kwaadaardig weefsel (HGD, T1RC).
    E.2.2Secondary objectives of the trial
    -To assess the ex-vivo tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective)
    -To assess the in-vivo TDR, TBR and DBR
    -To assess the accuracy of SGM-101 to discriminate HGD/T1RC from LGD ex-vivo.
    -To assess the accuracy of SGM-101 to discriminate HGD/T1RC from LGD in-vivo.
    - To assess the feasibility of SGM-101 to predict depth of cancerous invasion.
    -Feasibility of SGM-101 to discriminate between R0 and R1 resections.
    - The correlation between serum CEA expression to ex-vivo TDR, TBR and DBR
    - To assess whether the tissue CEA expression corelates to the accompanying fluorescent signal.
    -de ex-vivo tumor-achtergrondverhouding (TBR) en de dysplasie-achtergrondverhouding (DBR) beoordelen (de ex-vivo TDR is al aan bod gekomen in het hoofddoel).
    -beoordelen van de in-vivo TDR, TBR en DBR
    -Beoordelen van de nauwkeurigheid van SGM-101 om HGD/T1RC ex-vivo te onderscheiden van LGD.
    -Beoordelen van de nauwkeurigheid van SGM-101 om HGD/T1RC te onderscheiden van LGD in-vivo.
    - Beoordelen van de haalbaarheid van SGM-101 om de diepte van de kankerinvasie te voorspellen.
    -Haalbaarheid van SGM-101 om onderscheid te maken tussen R0 en R1 resecties.
    - De correlatie tussen serum CEA-expressie en ex-vivo TDR, TBR en DBR.
    - Nagaan of de weefsel CEA-expressie correleert met het begeleidende fluorescentiesignaal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    1. Patient must have suspected HGD/T1RC and scheduled for a local endoscopic en-bloc resection. The rectum is defined as the area between the linea dentata and 10cm ab ano.
    2. Age > 18 years old
    3. Patients should be capable and willing to give signed informed consent before study specific procedures.
    Om in aanmerking te komen voor deelname aan deze studie moet een proefpersoon aan alle volgende criteria voldoen:
    1. De patiënt moet vermoedelijk HGD/T1RC hebben en gepland zijn voor een lokale endoscopische en-bloc-resectie. Het rectum wordt gedefinieerd als het gebied tussen de linea dentata en 10 cm ab ano.
    2. Leeftijd > 18 jaar
    3. De patiënten moeten in staat en bereid zijn om vóór de studiespecifieke procedures een ondertekende geïnformeerde toestemming te geven.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study

    1. Prior participation in this study
    2. Previous administration of SGM-101
    3. Patients with a history of anaphylactic shock
    4. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential
    5. Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives.
    Een potentiële proefpersoon die voldoet aan een van de volgende criteria wordt uitgesloten van deelname aan dit onderzoek

    1. Eerdere deelname aan dit onderzoek
    2. Eerdere toediening van SGM-101
    3. Patiënten met een voorgeschiedenis van anafylactische shock
    4. Patiënten die zwanger zijn of borstvoeding geven, gebrek aan effectieve anticonceptie bij mannelijke of vrouwelijke patiënten met reproductieve mogelijkheden
    5. Elke aandoening die volgens de onderzoeker het welzijn van de patiënten of de doelstellingen van het onderzoek in gevaar kan brengen.
    E.5 End points
    E.5.1Primary end point(s)
    The ex-vivo T1RC/HGD to LGD ratio, in this manuscript named as the tumour-to-dysplasia ratio (TDR).
    The reason to choose ex-vivo instead of in-vivo TDR as main endpoint is because during ex-vivo imaging it is possible to accurately correlate fluorescent signal with tissue pathology (normal tissue, LGD, HGD/T1RC) in a standardized manner. This will be analyzed with a dedicated 700nm NIR-fluorescence scanner.
    De ex-vivo T1RC/HGD tot LGD ratio, in dit manuscript de tumor-dysplasie ratio (TDR) genoemd.
    De reden om ex-vivo in plaats van in-vivo TDR als belangrijkste eindpunt te kiezen is dat het tijdens ex-vivo beeldvorming mogelijk is om fluorescentiesignaal nauwkeurig te correleren met weefselpathologie (normaal weefsel, LGD, HGD/T1RC) op een gestandaardiseerde manier. Dit zal worden geanalyseerd met een speciale 700nm NIR-fluorescentiescanner.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During surgery in vivo pictures are made
    After surgery ex vivo pictures are performed.
    Subsequently the images and accompanying data can be analysed
    Tijdens de operatie worden in vivo foto's gemaakt
    Na de operatie worden ex vivo foto's gemaakt.
    Vervolgens kunnen de beelden en de bijbehorende gegevens worden geanalyseerd

    E.5.2Secondary end point(s)
    -Ex-vivo tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective)
    -In-vivo TDR, TBR and DBR
    -The accuracy of SGM-101 to discriminate HGD/T1RC from LGD ex-vivo. A TDR of ≥1,5 is defined as true positive. A TDR of <1.5 is defined as false negative. The accuracy is defined as the percentage of patients that are true positive. Same analysis will be performed for TBR and DBR.
    -The accuracy of SGM-101 to discriminate HGD/T1RC from LGD in-vivo. Accompanying endpoint is the percentage of true positives (fluorescent spot in vivo correlated to T1/HGD at pathology), false negatives (no fluorescent hotspot in vivo, T1/HGD component at pathology), false positives (fluorescent hotspot in-vivo, no T1/HGD at pathology) and true negatives (no fluorescent hotspot in vivo, no T1RC/HGD at pathology). Same analysis will be performed for TBR and DBR.
    - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)
    -The agreement of resection margins assessed by fluorescence and histopathology.
    -The correlation between serum CEA expression to TDR, TBR and DBR
    - The ratio of tissue CEA expression of T1/HGD divided by LGD, to TDR. The amount of CEA expression is determined by immunohistochemistry and quantified using the immunoreactive score (IRS)[28]. The ratio is calculated by dividing the IRS of T1RC/HGD by the IRS of LGD, after which this ratio is correlated to the TDR.
    The same analysis will be performed for the TBR and DBR
    -Ex-vivo tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective)
    -In-vivo TDR, TBR and DBR
    -The accuracy of SGM-101 to discriminate HGD/T1RC from LGD ex-vivo. A TDR of ≥1,5 is defined as true positive. A TDR of <1.5 is defined as false negative. The accuracy is defined as the percentage of patients that are true positive. Same analysis will be performed for TBR and DBR.
    -The accuracy of SGM-101 to discriminate HGD/T1RC from LGD in-vivo. Accompanying endpoint is the percentage of true positives (fluorescent spot in vivo correlated to T1/HGD at pathology), false negatives (no fluorescent hotspot in vivo, T1/HGD component at pathology), false positives (fluorescent hotspot in-vivo, no T1/HGD at pathology) and true negatives (no fluorescent hotspot in vivo, no T1RC/HGD at pathology). Same analysis will be performed for TBR and DBR.
    - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)
    -The agreement of resection margins assessed by fluorescence and histopathology.
    -The correlation between serum CEA expression to TDR, TBR and DBR
    - The ratio of tissue CEA expression of T1/HGD divided by LGD, to TDR. The amount of CEA expression is determined by immunohistochemistry and quantified using the immunoreactive score (IRS)[28]. The ratio is calculated by dividing the IRS of T1RC/HGD by the IRS of LGD, after which this ratio is correlated to the TDR.
    The same analysis will be performed for the TBR and DBR
    E.5.2.1Timepoint(s) of evaluation of this end point
    During surgery in vivo pictures are made
    After surgery ex vivo pictures are performed.
    Subsequently the images and accompanying data can be analysed
    Tijdens de operatie worden in vivo foto's gemaakt
    Na de operatie worden ex vivo foto's gemaakt.
    Vervolgens kunnen de beelden en de bijbehorende gegevens worden geanalyseerd
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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
    Het is een open gelabeld prospectief haalbaarheids- en doseringsonderzoek
    It is an open labeled prospective feasibility and dose-finding study
    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
    andere doseringen
    Other dosages
    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 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 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
    The trial ends after 20 patients were included, or:
    It will be stopped in case of an unacceptable tolerability profile based on the nature, frequency, and intensity of observed AEs judged jointly by the principal investigator, SurgiMab and the independent investigator Dr. Liefers
    Furthermore, if no fluorescent signal is seen for patients with a proven adenocarcinoma in the first 5 patients, the study will be stopped for futility.
    De proef eindigt nadat 20 patiënten zijn geïncludeerd, of:
    Het wordt gestopt in geval van een onaanvaardbaar verdraagbaarheidsprofiel op basis van de aard, frequentie en intensiteit van de waargenomen AE's, gezamenlijk beoordeeld door de hoofdonderzoeker, SurgiMab en de onafhankelijke onderzoeker dr. Liefers.
    Bovendien zal de studie worden stopgezet wegens nutteloosheid indien bij de eerste 5 patiënten met een bewezen adenocarcinoom geen fluorescerend signaal wordt gezien.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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, standard of care
    Volgens standaard zorg
    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 Decision2023-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
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