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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:2017-001842-82
    Sponsor's Protocol Code Number:W00101-IV-1-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-02-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-001842-82
    A.3Full title of the trial
    Phase I/II open label dose escalation and dose expansion study of intravenous infusion of W0101, an antibody-drug conjugate, in patients with advanced or metastatic solid tumors
    International, multicenter, open label study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study of a new investigational medicinal product for the
    treatment of patients with advanced or metastatic solid tumors
    A.4.1Sponsor's protocol code numberW00101-IV-1-01
    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 SponsorPIERRE FABRE MEDICAMENT
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointDr Hatem AZIM
    B.5.3 Address:
    B.5.3.1Street Address3 Avenue Hubert Curien
    B.5.3.2Town/ cityToulouse Cedex 1
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number+33534 50 63 88
    B.5.5Fax number+33534 50 65 92
    B.5.6E-mailhatem.azim@pierre-fabre.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 nameW0101
    D.3.2Product code W0101
    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 INNUnavailable
    D.3.9.1CAS number Unavailable
    D.3.9.2Current sponsor codeW0101
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or metastatic solid tumors (excluding lymphoma)
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic solid tumors (excluding lymphoma)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    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 determine the Maximum Tolerated Dose and schedule (MTDS) and to characterize the dose-limiting toxicities (DLTs), following administration
    of W0101 given as monotherapy

    Phase II ( expansion phase):
    To evaluate the efficacy by Overall Response Rate [ORR%] in subjects with specific tumor types showing IGF-1R overexpression.
    E.2.2Secondary objectives of the trial
    Phase I :
    • To evaluate the safety and tolerability of W0101
    • To determine the Recommended Dose for Expansion (RDE) cohorts
    • To evaluate preliminary antitumor activity
    • To characterize the pharmacokinetics (PK) of tADC, tmAb, cysteine drug linker (F558565) and naked cytotoxic drug (F554443)
    • To describe the immunogenicity

    Phase II (expansion phase) :
    • To evaluate the safety and tolerability profile
    • To characterize the preliminary antitumor activity by evaluation of progression free survival [PFS] and duration of response [DoR] in subjects with specific tumor types with an overexpression of IGF-1R.
    • To characterize the pharmacokinetics (PK) of tADC, tmAb, cysteine drug linker (F558565) and naked cytotoxic drug (F554443).
    • To evaluate the immunogenicity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects age ≥ 18 years
    2. Subjects with histologically or cytologically confirmed advanced or
    metastatic solid tumors (excluding lymphoma), unresponsive to standard treatment or for whom no standard treatment is available or appropriate
    i. In Cohort A1: Preferentially squamous non-small cell lung cancer, larynx carcinoma, ER positive breast cancer and soft tissue sarcomas
    ii. In Cohort A2 (inclusion criteria 37b):
    i. squamous Non-Small Cell Lung Cancer, squamous Head and Neck Carcinoma and Breast cancer (hormone receptor-positive, HER2-negative).
    ii. Others advanced solid tumor types with documented overexpression or genomic amplification of IGF-1R or that are deemed by the investigator to have a high probability of overexpressing IGF-1R.
    iii. In cohort A3 (inclusion criteria 2b):
    i. Subjects with histologically confirmed advanced or metastatic breast cancer ER+ HER2 negative
    ii. Prior treatment in the metastatic setting with
    a. CDK4/6 inhibitors
    b. At least one hormonal therapy
    c. One line of chemotherapy
    3. Formalin-fixed paraffin-embedded (FFPE) archived tumor tissue block or representative slides for retrospective assessment of IGF-1R status after inclusion in the study
    i. In cohort A3 (inclusion criteria 3c):
    Evidence of IGF-1R expression evaluated centrally on a tumor biopsy obtained either at baseline or within 6 months prior to study entry defined as ≥50% of tumor cells showing high membranous IGF-1R expression scored 3+ by IHC.
    4. ECOG performance status 0 or 1
    5. Adequate bone marrow at screening
    i. Absolute neutrophil count (ANC) ≥1,500/mm3.
    ii. Platelet count ≥150,000/mm3.
    iii. Hemoglobin ≥ 9 g/dL (6.2 mmol/L)
    Note: Any blood product transfusion is prohibited within 2 weeks before the first study treatment administration (Cohorts A1, and A2 only).
    6. Adequate liver function at screening
    i. Total Bilirubin ≤ 1.5 mg/dL (≤26 μmol/L, SI unit equivalent)
    ii. AST and ALT ≤ 3 upper limit of normal (ULN), ULN ≤ 5 in case of liver metastasis
    iii. For subjects with Gilbert's syndrome: total bilirubin <2.5 ULN
    7. Adequate renal function at screening Note: Serum creatinine ≤ 1.5 normal institutional limits or calculated (Cockroft- Gault) creatinine clearance ≥ 60 mL/min for subjects with creatinine levels above 1.5 normal institutional limits.
    8. Adequate electrolyte profile, defined as absence of clinically significant alterations requiring intravenous corrective measures.
    Note: Subjects with electrolyte (calcium, potassium and magnesium) alterations considered as not clinically significant as per the investigator assessment may be eligible for the study.
    9. Subject must have recovered from all non-haematological toxicities from previous cancer therapies to at least grade 1 (except alopecia)
    10. Subject must have measurable disease as per RECIST v1.1 criteria.
    In Cohort A3, subjects with bone-only metastatic cancer could be eligible provided that they have a lytic or mixed lytic-blastic lesion that can be accurately assessed by CT-scan or MRI. Subjects with blastic bone-only metastasis are not eligible.
    11. Non pregnant and adequate method of contraception for female subject of child-bearing potential:
    i. Negative serum beta human chorionic gonadotropin (β-HCG) test or negative urine pregnancy test within 72h prior first study treatment administration.
    ii. Use of an effective method of contraception (hormonal contraception or intra-uterine device) assessed by the investigator, before the first study treatment administration, and agreement to go on using it during the whole duration of the study and up to 4 months after the last dose of the study treatment
    Note: a female subject of childbearing potential is a woman who is not permanently sterilized or not postmenopausal (postmenopausal is defined as 12 months with no menses without an alternative medical cause).
    12. Adequate method of contraception for fertile male with a childbearing potential partner:
    Note: Use of double barrier contraception method (use of condom for male and effective contraception method for the partner) from the entire duration of the study to 4 months after the last dose of the study treatment.
    13. Having signed written informed consent, prior to any screening procedure
    14. Affiliated or beneficiary of a social security system (if applicable in the national regulation)
    E.4Principal exclusion criteria
    15. History of anti-cancer therapies within 4 weeks (or ≤ 5 half lives for targeted agents) of initiating study treatment
    Note: Anti-cancer therapies are defined as: major surgery, radiotherapy (palliative setting is allowed), hormone therapy, immunotherapy, any conventional cytotoxic chemotherapy or other anti-cancer treatments.
    For cohorts A1 and A2 only, treatment with hormonal therapy for patients with breast or prostate cancer is allowed during the 4 week window.
    16. Known active or uncontrolled infections (bacterial, fungal, viral including HBV and HCV infections)
    17. Symptomatic brain metastases, CNS tumors
    a. In Cohort A3 (exclusion criteria 17a):
    ii. Subjects with evidence (or history) of brain metastasis could be included provided that they were successfully treated and have been stable for more than 6 months.
    18. Symptomatic motor or sensory peripheral neuropathy (≥ grade 2) (cohorts A1 and A2 only)
    19. Subjects having ophthalmologic abnormalities (cohorts A1 and A2 only)
    Note: Ophthalmologic abnormalities are defined as subjects with monocular vision or having media opacities or any other condition that precludes monitoring of the retina or the fundus or having a history or current ophthalmology exam with retina or cornea abnormalities, especially central serous retinopathy, age related macular degeneration, retina degradation, corneal ulcers, cornea dystrophies or other pathology at the discretion of the ophthalmologist/investigator.
    19.a In cohort A3 only : Subjects having rapid progressive ophthalmologic abnormalities will be excuded.
    20. Active serious systemic disease (infection, organic or dysmetabolic disease)
    21. Subjects with uncontrolled high blood pressure
    Note: systolic blood pressure, SBP >150 mmHg and/or diastolic blood pressure, DBP > 95 mmHg despite treatment on 2 out of 3 determinations done in case that the first one meets the criterion for exclusion
    22. Subjects with Type 1 or 2 diabetes mellitus considered as poorly controlled according to the investigator's judgment (exclusion criteria 22a for cohort A3).
    Note (cohorts A1 and A2 only):
    i. Hb A1C ≥ 7%
    ii. Diabetes mellitus requiring insulin treatment
    iii. Diabetes mellitus with clinical signs
    iv. Fasting Plasma Glucose (FPG) ≥ 140 mg/dL / 7.8 mmol/L
    23. Serum albumin < 30 g/L at screening
    24. History of another malignancy
    Note: (except adequately treated in situ carcinoma of the cervix or nonmelanoma carcinoma of the skin, or any other curatively treated malignancy that has not been treated or recurred in the prior 3 years).
    25. Biologic therapy (eg, antibodies), including ADCs: ≤ 4 weeks before first study treatment administration
    26. Participation into a clinical study of an investigational agent within 4 weeks before the first study treatment administration.
    Note: Subjects participating in the follow up period of previous studies (with no drug administration) may be eligible for the study
    27. Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echography at screening
    28. QTc > 470 msec on screening ECG or congenital long QT syndrome (cohorts A1 and A2 only)
    29. Subjects who have any medical condition that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
    Note: Any severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for the study
    30. Prior anti IGF-1R therapy (cohorts A1 and A2 only) For cohort A3 only (exclusion criteria 30 a): prior treatment with IGFR targeting therapy (example ADC, monoclonal antibodies, etc. )
    31. Subject liable not to comply with protocol instructions in the investigator's opinion
    32. Subject linguistically or mentally unable to understand the nature, objectives and possible consequences of the trial, or refusing to subject himself/herself to its constraints
    33. Subject family member or work associate (secretary, nurse, technician,..) of the Investigator
    34. Subject having forfeited his / her freedom by administrative or legal award or being under guardianship
    35. Female subject pregnant or lactating
    36. Known hypersensitivity to drug or metabolites of similar chemical classes
    E.5 End points
    E.5.1Primary end point(s)
    Dose escalation phase :
    Dose-limiting toxicities (DLTs)

    Dose expansion phase :
    Overall Response Rate ORR [Complete Response + Partial Response] as determined by RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dose escalation phase :
    Will be assesed during the DLT evaluation periods

    Dose expansion phase :
    Will be assessed every 6 weeks
    E.5.2Secondary end point(s)
    Dose escalation phase :
    - Safety and tolerability profile caracterized by type frequency, severity, intensity (graded by NCI CTCAE version 4.03)
    - ORR [CR+PR] as determined by RECIST v1.1
    - PK parameters
    - HAHA levels

    Dose expansion phase :
    - Safety and tolerability profile caracterized by type frequency, severity, intensity (graded by NCI CTCAE version 4.03)
    - Progression Free Survival (PFS)
    - Duration of Response (DoR)
    - PK parameters
    - HAHA levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along 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
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    The end of study is defined as the last follow up visit for the last subject. If the last subject discontinues treatment for a following reason : withdrawal of consent, loss to follow-up, or death, the end of study is defined as the time point when the last participant discontinues treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months10
    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: 247
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 133
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 380
    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)
    Follow-up will be performed every 12 weeks for every subject who has not progressed at the time of discontinuation of study treatment until disease progression is reported, initiation of subsequent anticancer therapies, Lost to Follow-up or death, whichever occurs first
    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 Decision2022-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-05
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