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    The EU Clinical Trials Register currently displays   39233   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-001263-20
    Sponsor's Protocol Code Number:D-FR-01087-001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-001263-20
    A.3Full title of the trial
    An International Multicentre, Open-Label First in Human Phase I/II study to evaluate the safety, tolerability, biodistribution and antitumour activity of 177Lu-3BP-227 for the treatment of subjects with solid tumours expressing neurotensin receptor 1
    Étude clinique internationale multicentrique, en ouvert, de première administration chez l’homme (phase I/II) évaluant la sécurité, la tolérance, la biodistribution et l’activité antitumorale du 177Lu-3BP-227 dans le traitement de sujets présentant des tumeurs solides exprimant le récepteur 1 de la neurotensine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international, first in Human study to evaluate the safety and activity of 177Lu-3BP-227 (including the distribution in the various parts of the body) in patients with solid tumours expressing neurotensin receptor type 1.
    Étude clinique internationale de première administration chez l’homme, évaluant la sécurité et l’activité du 177Lu-3BP-227 (y compris la distribution du produit et de la radioactivite dans les différentes parties du corps) chez des patients atteints de tumeurs solides exprimant le récepteur de type 1 de la neurotensine.
    A.4.1Sponsor's protocol code numberD-FR-01087-001
    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 SponsorIpsen Pharma SAS
    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 supportIpsen Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address65 quai Georges Gorse
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number0033158 33 50 00
    B.5.5Fax number0033158 33 50 01
    B.5.6E-mailct-application@ipsen.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 name177Lu-3BP-227
    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 INNNone
    D.3.9.1CAS number 1613265-38-5
    D.3.9.2Current sponsor code3BP-227
    D.3.9.3Other descriptive name3BP-227
    D.3.9.4EV Substance CodeSUB187988
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor code177LU
    D.3.9.3Other descriptive nameLUTETIUM (177LU) CHLORIDE
    D.3.9.4EV Substance CodeSUB168687
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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.IMP: 2
    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 name177Lu-3BP-227
    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 INNNone
    D.3.9.1CAS number 1613265-38-5
    D.3.9.2Current sponsor code3BP-227
    D.3.9.3Other descriptive name3BP-227
    D.3.9.4EV Substance CodeSUB187988
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.3Other descriptive nameLUTETIUM (177LU) CHLORIDE
    D.3.9.4EV Substance CodeSUB168687
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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.IMP: 3
    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 name177Lu-3BP-227
    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 INNNone
    D.3.9.1CAS number 1613265-38-5
    D.3.9.2Current sponsor code3BP-227
    D.3.9.3Other descriptive name3BP-227
    D.3.9.4EV Substance CodeSUB187988
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.3Other descriptive nameLUTETIUM (177LU) CHLORIDE
    D.3.9.4EV Substance CodeSUB168687
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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.IMP: 4
    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 name177Lu-3BP-227
    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 INNNone
    D.3.9.1CAS number 1613265-38-5
    D.3.9.2Current sponsor code3BP-227
    D.3.9.3Other descriptive name3BP-227
    D.3.9.4EV Substance CodeSUB187988
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number275
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.3Other descriptive nameLUTETIUM (177LU) CHLORIDE
    D.3.9.4EV Substance CodeSUB168687
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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.IMP: 5
    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 name177Lu-3BP-227
    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 INNNone
    D.3.9.1CAS number 1613265-38-5
    D.3.9.2Current sponsor code3BP-227
    D.3.9.3Other descriptive name3BP-227
    D.3.9.4EV Substance CodeSUB187988
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number325
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.3Other descriptive nameLUTETIUM (177LU) CHLORIDE
    D.3.9.4EV Substance CodeSUB168687
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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.IMP: 6
    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 name177Lu-3BP-227
    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 INNNone
    D.3.9.1CAS number 1613265-38-5
    D.3.9.2Current sponsor code3BP-227
    D.3.9.3Other descriptive name3BP-227
    D.3.9.4EV Substance CodeSUB187988
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.3Other descriptive nameLUTETIUM (177LU) CHLORIDE
    D.3.9.4EV Substance CodeSUB168687
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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.IMP: 7
    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 name177Lu-3BP-227
    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 INNNone
    D.3.9.1CAS number 1613265-38-5
    D.3.9.2Current sponsor code3BP-227
    D.3.9.3Other descriptive name3BP-227
    D.3.9.4EV Substance CodeSUB187988
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number562.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.3Other descriptive nameLUTETIUM (177LU) CHLORIDE
    D.3.9.4EV Substance CodeSUB168687
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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 with unresecable, metastatic or locally advanced cancers expressing Neurotensin Receptor 1 (NTSR1).
    E.1.1.1Medical condition in easily understood language
    Patients with unresecable, metastatic or locally advanced cancers expressing Neurotensin Receptor 1.
    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 LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic cancer
    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 10061451
    E.1.2Term Colorectal cancer
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    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 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10051066
    E.1.2Term Gastrointestinal stromal tumour
    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 10015560
    E.1.2Term Ewing's sarcoma
    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 10015562
    E.1.2Term Ewing's sarcoma 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I
    To establish the safety and tolerability of fractionated intravenous (i.v.) administrations of 177Lu-3BP-227 in subjects with unresectable, locally advanced or metastatic cancers expressing NTSR1.

    Phase II
    To estimate ORR of fractionated i.v. administrations of 177Lu-3BP-227 in subjects with unresectable, locally advanced or metastatic cancers expressing NTSR1.

    E.2.2Secondary objectives of the trial
    Phase I
    a) To determine the whole-body distribution of 177Lu-3BP-227 and pharmacokinetics (PK) of both 177Lu-3BP-227 and 3BP-227.
    b) To determine the radiation dosimetry of 177Lu-3BP-227 (organ exposure to radiation).
    c) To describe the preliminary antitumour activity of 177Lu-3BP-227.

    Phase II
    a) To further evaluate the safety profile of 177Lu-3BP-227 at the radioactivity recommended by the phase I results.
    b) To further assess the response to treatment with 177Lu-3BP-227 using RECIST version 1.1 and/or positron emission tomography (PET) Response Criteria in Solid Tumours (PERCIST) version 1.0 criteria.
    c) To further characterise the whole-body distribution and dosimetry of 177Lu-3BP-227 and PK of both 177Lu-3BP-227 and 3BP-227.
    d) To describe the influence of 177Lu-3BP-227 on the health-related quality of life of treated subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Signed informed consent form prior to all study procedures.
    (2) Aged 18 years or older.
    (3) Histologically or cytologically confirmed unresectable, locally advanced or metastatic disease and has received prior lines of standard-of-care chemotherapy/treatment and has no further suitable treatment options and a documented decision by a multidisciplinary oncology board including a specialist of the concerned pathology.
    (4) Subjects have:
    (a) PDAC, or
    (b) CRC (colorectal adenocarcinoma), or
    (c) GC (gastric adenocarcinoma), or
    (d) Gastrointestinal Stromal Tumours (GIST), or
    (e) SCCHN, or
    (f) ES.
    (5) Tumours showing:
    (a) uptake of 177Lu-3BP-227 (screening formulation) in known primary or metastatic sites as judged by the investigator to be greater than
    background; or
    (b) uptake of 111In-3BP-227 in known primary or metastatic sites (for subjects who participated in Study D-FR-01087-002) as judged by the investigator to be greater than background.
    (6) Measurable disease (based on RECIST version 1.1).
    (7) Criterion 7 is removed by protocol amendment.
    (8) Documentation of progressive disease in the 6 months prior to study start (treatment).
    (9) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (unless if disability is related to surgery in ES and agreed with the
    sponsor).
    (10) Adequate organ function as evidenced by:
    (a) Leukocytes ≥ 3000/μL
    (b) Absolute neutrophil count ≥1500/μL
    (c) Platelets ≥75,000/μL
    (d) Hb >9g/dL or >10 g/dL (if history of cardiac disease)
    (e) Total serum bilirubin ≤2×upper normal institutional limits (ULN)
    (f) Aspartate aminotransferase/alanine aminotransferase ≤2.5×ULN (≤5×ULN if subject has liver metastases)
    (g) Estimated glomerular filtration rate ≥55mL/min.
    (11) Estimated life expectancy of >3 months.
    (12) Female subjects must not be pregnant or lactating at study entry and during the course of the study and must not become pregnant for at least 6 months following the last study treatment. Women of childbearing potential must agree to use a highly effective method of contraception (see note below).
    (13) Male subjects must not father children during the study and for at least 6 months after the last study treatment and in addition must agree
    to use a condom for this period to protect his partner from contamination with the IMP. For males with partners who are of child bearing potential, effective contraception is a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods), but these are not considered to be highly effective. A man is considered to be infertile if he has had bilateral orchidectomy or successful vasectomy. Effective contraception includes a female partner of childbearing potential if she is using highly efficacious contraception (see note below), but the male subject must agree to use a condom to protect his partner as described above.
    (14) Must be willing and able to comply with study restrictions and to remain at the clinic for the required time during the study period and willing to return to the clinic for the follow-up evaluation, as specified in the protocol.

    Phase II
    The inclusion criteria for phase II will be revised based on the scenario adopted and indication(s) selected for investigation in phase II. This will be documented as part of a protocol amendment.
    E.4Principal exclusion criteria
    Phase I/II
    (1) Prior treatment received
    (a) Any antitumour treatment since last documented disease progression
    (b) Any chemotherapy within 3 weeks or nitrosourea within 6 weeks prior to first treatment investigational medicinal product (IMP) administration
    (c) Any curative radiotherapy within 4 weeks or palliative radiotherapy within 7 days prior to first treatment IMP administration
    (d) Any, monoclonal antibodies within 4 weeks or tyrosine kinases inhibitors within 2 weeks prior to the first treatment IMP administration
    (e) Any other IMP within 2 weeks prior to first treatment IMP administration, if the previous compound is a mechanism based molecularly targeted agent whose half-life (t1/2) is not well characterised.
    (2) Brain metastases.
    (3) Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject at high risk of renal toxicity during the study.
    (4) Only nonmeasurable metastatic bone lesions.
    (5) Existing or planned colostomy during study participation.
    (6) Any history of inflammatory bowel disease.
    (7)Any uncontrolled significant medical, psychiatric or surgical condition or laboratory finding, that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.
    (8) Clinically significant abnormalities on electrocardiogram (ECG) at screening including corrected QT interval (Fridericia's formula) >450 msec for males or 470 msec for females at screening.
    (9) Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.
    (10) Criterion 10 is removed by protocol amendment.
    (11) Any unresolved NCI-CTCAE Grade 2 or higher (except alopecia) from previous antitumour treatment and/or medical/surgical procedures/interventions.
    (12) Known allergy to IMP or its excipients administered in this study, including imaging contrast media.
    (13) Positive pregnancy test (female subjects).
    (14) Likely to be uncompliant or uncooperative during the study, in the judgment of the investigator.
    (15) Unable to understand the nature, scope and possible consequences of the study, in the judgment of the investigator.
    (16) Sponsor employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    For the dose escalation, the primary endpoint is MTCA or the maximum administered cumulative activity (MACA), if the MTCA is not identified during the dose escalation part. The primary variables used for the MTCA determination will be the incidence of DLTs (as defined above) and the organ exposure to radiation during two cycles of treatment. The DLT period for the determination of the primary endpoint starts at the first administration of 177Lu-3BP-227 to EOCT/ED.
    Safety evaluation will encompass DLTs, frequency and nature of adverse events (AEs), abnormal findings from physical examination, vital signs, 12-lead ECG and 24-hour 3 lead ECG Holter, ECOG performance status treatment related deterioration and clinical laboratory tests abnormalities (including haematology, blood biochemistry, hormone analysis, urinalysis and pregnancy test).
    In case the phase I dose expansion cohorts are implemented, the primary endpoint will be safety and tolerability measured by the type, severity, expectedness and frequency of AEs.

    Phase II
    The primary endpoint is ORR measured by CT or MRI using RECIST version 1.1. Tumour response assessments are performed every 8 weeks or at the time of occurrence of first clinical signs of disease progression as determined by the investigator.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    Phase I
    Pharmacokinetics, biodistribution and dosimetry
    For biodistribution and dosimetry of 177Lu-3BP-227, the secondary endpoints are:
    a) Maximal uptake (%); maximal concentration achieved (Cmax); time post injection to achieve maximal concentration (Tmax); area under the curve (AUC) at the target lesions, discernible organs and blood; terminal t1/2 of activity concentrations in blood.
    b) Highest absorbed dose, specific absorbed dose to the target lesions (Gy/GBq), specific absorbed dose per organ (Gy/GBq) and cumulative absorbed organ doses (Gy).
    For PK of 3BP-227, the secondary endpoints are:
    c) Pharmacokinetic parameters including, but not limited to, Cmax, AUC, t1/2, clearance (CL), volume of distribution (Vd), cumulative amount of unchanged drug excreted into the urine (Ae), renal clearance of the drug from plasma (CLR), as measured in plasma and urine at defined timepoints.

    Pharmacodynamic/efficacy
    a) Objective response rate and disease control rate (DCR), as determined by RECIST version 1.1 in subjects who received IMP.
    b) Progression-free survival (PFS) and overall survival (OS) rates as determined from start of study treatment until occurrence of event and/or end of observation period.
    c) Evaluation of metabolic tumour response as determined by PERCIST (version 1.0) or practical PERCIST.
    d) Changes in serum tumour markers relevant and specific to the underlying tumour disease from Day of the first treatment administration to EOCT, which is planned 6 weeks after the second 177Lu 3BP 227 dose administration.

    Phase II
    Efficacy
    a) Disease control rate, time to progression, time to response, duration of response as per RECIST version 1.1.
    b) Qualitative and quantitative changes in tumour-to-background uptake using PERCIST version 1.0.
    c) Progression-free survival (PFS) and OS as determined from start of study treatment until occurrence of event and/or 6 and 12 months after start of study treatment.
    d) Changes in serum tumour markers relevant and specific to the underlying tumour disease from baseline to EOCT.

    Subject Reported Outcomes
    a) Changes in health-related quality of life scores from baseline to EOCT measured by validated questionnaires.

    Safety
    a) Safety and tolerability measured by the type, severity, expectedness and frequency of AEs.

    Pharmacokinetics, biodistribution and dosimetry
    a) For PK, biodistribution and dosimetry, the endpoints will be similar as for phase I.


    Exploratory endpoints
    Phase I/II
    a) Tumour uptake of 177Lu-3BP-227 and the correlation with NTSR1 expression on tumour biopsies.
    b) If applicable, tumour microenvironment and other markers of interest (such as NTSR1 expression, Ki67, gene expression and DNA damage) in
    tumour biopsies taken at baseline, at EOCT visit or at disease progression, whichever occurs earlier.
    c) Genomic profiling in circulating cfDNA and in germline DNA.
    d) Gene mutation status in correlation with clinical outcome.
    e) Specific renal safety biomarkers specific for proximal tubulus toxicity.


    Biobanking (optional):
    Serum and whole blood ribonucleic acid samples will be stored for further biomarker analysis after the end of the study. Analysis of additional biomarkers from the biobank samples will be performed outside the scope of the main study and reported separately.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    dosimetry, antitumour activity
    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.8.2.4Number of treatment arms in the trial6
    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 EEA7
    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
    Belgium
    France
    Netherlands
    Switzerland
    United States
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 320
    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 Decision2018-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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