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    Summary
    EudraCT Number:2021-001030-19
    Sponsor's Protocol Code Number:FP2CLI003
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-04-28
    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 ConcernedFinland - Fimea
    A.2EudraCT number2021-001030-19
    A.3Full title of the trial
    A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate safety, tolerability and efficacy of bexmarilimab given as a single dose before surgery in renal or colon cancer patients
    A.3.2Name or abbreviated title of the trial where available
    MATINS RENACOL
    A.4.1Sponsor's protocol code numberFP2CLI003
    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 SponsorFaron Pharmaceuticals Ltd
    B.1.3.4CountryFinland
    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 supportFaron Pharmaceuticals Ltd
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFaron Pharmaceuticals Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressJoukahaisenkatu 6
    B.5.3.2Town/ cityTurku
    B.5.3.3Post code20520
    B.5.3.4CountryFinland
    B.5.6E-mailregulatory.affairs@faron.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.3.2Product code FP-1305
    D.3.4Pharmaceutical form Concentrate for 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 INNBexmarilimab
    D.3.9.2Current sponsor codeFP-1305
    D.3.9.3Other descriptive nameCLEVER-1 ANTIBODY
    D.3.9.4EV Substance CodeSUB216117
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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
    -Localized clear cell renal cell cancer
    -Colon adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    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 LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    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
    •To determine the safety and tolerability of three different doses of single neoadjuvant dose of bexmarilimab for subjects with localized clear cell renal cell cancer and for subjects with colon adenocarcinoma prior radical surgery.
    E.2.2Secondary objectives of the trial
    •To assess radiological response rate of single neoadjuvant dose of bexmarilimab
    •To assess pathological response rate of single neoadjuvant dose of bexmarilimab
    •Long-term clinical benefit of single neoadjuvant dose of bexmarilimab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of signed and dated informed consent form.
    2.Ability and stated willingness to comply with all study procedures and availability for the duration of the study.
    3.Male or female, aged > 18 years.
    4.Adequate general health (ECOG 0 or 1) to undergo planned radical surgery for renal cell or colon cancer.
    5.Adequate bone marrow, liver and kidney function defined as:
    Blood white blood cell ≥ lower limit of normal
    Blood neutrophil count ≥ 1x109/L
    Blood platelet count ≥ 100x109/L
    Blood haemoglobin ≥ 9.0 g/dL
    Creatinine clearance > 40 mL/min calculated by Cockcroft-Gault formula
    AST ≤ 3 X Upper Limit of Normal (ULN)
    ALT ≤ 3 X ULN
    Bilirubin ≤ 1.5 X ULN
    Albumin ≥ 3.0 g/dL
    6.Histologically confirmed clear cell renal cell cancer planned to be treated with surgery with curative intent (Renal cell cancer cohort). In renal cell observation cohort, histological confirmation not mandatory.
    or
    Histologically confirmed adenocarcinoma of the colon planned to be treated with surgery with curative intent (Colon cancer cohort).
    Additional inclusion criteria for subjects planned to have a single neoadjuvant dose of CLEVER-1 antibody bexmarilimab:
    7.For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 12 weeks after the end of single neoadjuvant dose of bexmarilimab administration.
    8.For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks after the administration of single neoadjuvant dose of bexmarilimab.
    E.4Principal exclusion criteria
    1.Evidence of metastatic disease making subject not eligible for surgical resection, except for local nodal metastatic disease.
    2.History of previous treatment for renal cell cancer (renal cell cancer cohorts) or colon cancer (colon cancer cohorts).
    3.Less than 3 months since the last dose of any cancer therapy prior to consenting.
    4.Less than 4 weeks since any major surgery.
    5.Treatment with any investigational agent within 4 weeks before consenting.
    6.History of another malignancy without curative treatment or suspicion of disease recurrence.
    7.Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure New York Heart Association (NYHA) class 2, Myocardial Infarction (MI) within 6 months or laboratory finding that in the view of the investigator makes it undesirable for the subject to participate in the trial.
    8.Any medical condition that the Investigator considers significant to compromise the safety of the subject or that impairs the interpretation of IMP toxicity assessment.
    9.Confirmed human immunodeficiency virus infection.
    10.Confirmed hepatitis B or C virus infection.
    11.Symptomatic cytomegalovirus infection.
    12.Subjects with active autoimmune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
    13.The subject requires systemic corticosteroid or other immunosuppressive treatment.
    14.Subjects with organ transplants.
    15.Subjects in dialysis.
    16.Use of Live (attenuated) vaccines for 30 days prior to the start of study treatment, during
    treatment, and until last visit.
    17.Subject is unwilling or unable to comply with treatment and trial instructions.
    18.Pregnancy or lactation.
    19.Medical history of chronic ulcers, abnormal liver function or previous liver problems/diseases
    E.5 End points
    E.5.1Primary end point(s)
    •Adverse events ≥Grade 3 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 during the 28 days (4 weeks) following the single dose of bexmarilimab, and Surgical adverse events ≥Grade 3 according to the Clavien-Dindo classification occurring during the 14 days (2 weeks) following the surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    •28 days following the administration of bexmarilimab
    •14 days following the surgery
    E.5.2Secondary end point(s)
    •Adverse events until the follow-up visit on Day 84
    •Radiological response rate according to Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) (Day 13)
    •Pathological response rate evaluated with Ryan tumour regression rate (Day 14)
    •Long-term clinical benefit measured by disease-free survival assessed at 1, 3 and 5 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Day 84
    • Day 13
    • Day 14
    • At 1, 3 and 5 years
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety in combination with surgery
    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 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 Yes
    E.8.2.3.1Comparator description
    Standard of care
    E.8.2.4Number of treatment arms in the trial3
    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 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 years1
    E.8.9.1In the Member State concerned months8
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state62
    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)
    Long-term clinical benefit measured by disease-free survival assessed at 1, 3 and 5 years from hospital records.
    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 Decision2021-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-28
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