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    Summary
    EudraCT Number:2021-002104-12
    Sponsor's Protocol Code Number:FP2CLI004
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-12
    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 ConcernedFinland - Fimea
    A.2EudraCT number2021-002104-12
    A.3Full title of the trial
    A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination with Standard of Care Therapy in Patients with Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to evaluate safety, tolerability and preliminary efficacy of FP-1305 (bexmarilimab) in haematological malignancies in combination with azacitidine or azacitidine and venetoclax
    A.3.2Name or abbreviated title of the trial where available
    BEXMAB
    A.4.1Sponsor's protocol code numberFP2CLI004
    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
    -Myelodysplastic Syndrome
    -Chronic Myelomonocytic Leukemia
    -Acute Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    Advanced haematological malignancies
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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
    1. To determine the safety and tolerability of bexmarilimab in combination with SoC treatment to identify the recommended dose for expansion (RDE).

    Phase II
    1. To evaluate the preliminary clinical efficacy of bexmarilimab at recommended phase 2 dose (RP2D) in combination with SoC.
    E.2.2Secondary objectives of the trial
    Phase I
    1. To assess preliminary clinical efficacy of bexmarilimab in combination with SoC treatment.
    2. To characterize the pharmacokinetic (PK) profile of bexmarilimab in combination with SoC treatment.
    3. To assess the immunogenicity of bexmarilimab.

    Phase II
    1. To further evaluate the extended safety and tolerability of bexmarilimab at RDE/one dose level below the RDE/RP2D in combination with SoC treatment.
    2. To investigate additional preliminary efficacy parameters of bexmarilimab in combination with SoC.
    3. To characterize the pharmacokinetic (PK) profile of bexmarilimab in combination with SoC treatment.
    4. To assess the immunogenicity of bexmarilimab.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Projected life expectancy of at least 12 weeks.
    3. Male or female patients ≥ 18 years of age who present with one of the following conditions:
    a. Morphologically confirmed diagnosis of MDS based on 2016 WHO classification with indication for azacitidine treatment based on local standard medical practice with one of the following risk categories based on the rIPSS:
    i. Very high (> 6 points)
    ii. High (> 4.5 - ≤ 6 points)
    iii. Intermediate (> 3 - ≤ 4.5 points).
    b. Morphologically confirmed diagnosis of CMML based on 2016 WHO classification with 10-19 % marrow blasts with indication for azacitidine treatment based on local standard medical practice.
    c. CMML and MDS patients who presents with failure to achieve response to therapy with HMA or therapy regimen including HMA. Failure is considered if the patient has not achieved CR or mCR response after 4 cycles of therapy or the disease is progressing (increasing bone marrow blast count with decreasing blood counts) during treatment with HMA.
    d. Morphologically confirmed diagnosis of relapsed or refractory AML (except acute promyelocytic leukemia) following at least 1 line of prior therapy with indication for azacitidine treatment based on local standard medical practice.
    e. Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment based on local standard medical practice. Specific criteria for non-eligibility for induction chemotherapy:
     Patient must be ≥ 75 years of age
    OR
     ≥ 18 to 74 years of age and ineligible for intensive chemotherapy meeting at least one of the criteria following:
    • Clinically significant comorbidities, as documented by at least 1 of the following:
    o Left ventricular ejection fraction (LVEF) ≤ 50%.
    o Lung diffusion capacity for carbon monoxide (DLCO) ≤ 65% of expected.
    o Forced expiratory volume in 1 second (FEV1) ≤ 65% of expected.
    o Chronic stable angina or congestive heart failure controlled with medication.
    o Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3.
     Other contraindication(s) to anthracycline therapy (must be documented); creatinine clearance ≥30 mL/min to < 45 mL/min; moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × upper limit of normal (ULN).
     Adverse risk genetics and/or TP53 mutation associated with poor outcome with standard chemotherapy.
     Antecedent MDS treated previously with standard chemotherapy and/or allogeneic transplantation.
    4. Leukocyte count < 20x109/L (< 25 x109/L for newly diagnosed AML). Hydroxycarbamide use is permitted to meet this criterion in MDS and AML but not in CMML.
    5. Patient must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined by the Cockcroft Gault formula.
    6. Patient must have adequate liver function as demonstrated by:
    a. ALT and aspartate transaminase (AST) ≤ 3.0 × ULN
    b. Bilirubin ≤ 1.5 × ULN (unless related to Gilbert’s syndrome).

    E.4Principal exclusion criteria
    1. Patient has acute promyelocytic leukemia (APL).

    2. Myeloproliferative CMML as defined by leukocyte count > 13 x109/L. Of note, the use hydroxycarbamide is not allowed to meet this criterion in patients with CMML.

    3. ECOG >2 (except newly diagnosed AML where ECOG 3 is allowed for patients ≥ 18 to 74 years).

    4. Patient has known active central nervous system (CNS) involvement with myeloid malignancy (note: CSF or radiological investigations are not required without clinical suspicion). Patients with prior history of CNS involvement may be eligible if they had 2 consecutive lumbar punctures negative for CNS leukemia prior to enrollment and no clinical signs of active or progressive CNS leukemia.

    5. Patient with human immunodeficiency virus (HIV) infection or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.

    6. Patient has cardiovascular disability status of New York Heart Association Class >2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in palpitations, fatigue, dyspnea, or anginal pain.

    7. Patient has a chronic respiratory disease that requires continuous oxygen use; evidence of other clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participation in this study; active or poorly controlled systemic infection requiring therapy (viral, bacterial, or fungal); or graft versus host disease requiring treatment with immunosuppressants or steroids ≥ 10mg prednisolone or equivalent.
    8. Allogeneic transplantation less than 6 months prior screening.
    9. Patient has a history of other malignancies prior to study entry, with the exception of previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and have not recurred within 2 years after the last therapy prior to study treatment. Of note, patients on maintenance therapy such as tamoxifen for breast cancer or other maintenance approaches would be eligible as long as the malignancy did not recur within 2 years prior to study treatment.
    10. Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
    11. The patient requires systemic corticosteroid (≥10 mg/day prednisone or equivalent) or other immunosuppressive treatment. Topical, nasal, inhaled and ophthalmic steroids are allowed.
    12. Use of live (attenuated) vaccines for 30 days prior to the start of study treatment, during treatment, and until last visit.
    13. Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than 14 days or five half-lives (whichever is shorter) from a small molecule targeted therapy or oral anticancer chemotherapy before the first study treatment administration.
    14. Major surgery within 4 weeks of the first dose of study treatment (procedures like insertion of a central venous access device are not considered as major surgery).
    15. Any immunotherapy or investigational therapy within preceding 4 weeks from the first study treatment administration and during the study.
    16. Pregnant or lactating women.
    17. Women of child-bearing potential (WOCBP), unless they are using highly effective methods of contraception *) for at least 1 month prior to first dose of study treatment and agreement to use such a method during study participation and for an additional 12 weeks after stopping the study medication.
    18. Men of reproductive potential, unless they are using highly effective methods of contraception (e.g. condom, vasectomy) with partner that could be of childbearing potential during study participation and for an additional 12 weeks after stopping the study medication.
    19. History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher. If the history of abnormal liver function is related to previous hematologic malignancy or it’s treatment, the patient may be enrolled after discussing with the sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    1. Reporting of incidence and frequency of dose limiting toxicities (DLTs), and frequency and severity of adverse events (AE), SAEs and laboratory abnormalities.

    Phase II
    1. Preliminary efficacy will be investigated per indication as follows:
    o Complete response (CR) rate for MDS and CMML-2.
    o Overall response rate (ORR) for MDS and CMML failure to prior HMA.
    o CR for r/r AML.
    o CR rate for newly diagnosed AML.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -During the whole DLT period (28 days) for safety parameters
    -AEs during the whole study
    -Response assessments for preliminary efficacy done end of cycle 1 to cycle 6, followed by every 3 months
    E.5.2Secondary end point(s)
    Phase I
    1. Clinical efficacy measures include disease-specific response criteria and progression and survival analyses.
    2. PK samples at defined timepoints of single and repeat bexmarilimab administration and derived PK parameters.
    3. Anti-bexmarilimab antibody detection.

    Phase II
    1. Frequency and severity based on NCI-CTCAE v 5.0 grading of adverse events (AE), SAE and laboratory abnormalities.
    2. Extended preliminary efficacy to include disease-specific response criteria and progression and survival analyses.
    3. Anti-bexmarilimab antibody (immunogenicity) detection.

    E.5.2.1Timepoint(s) of evaluation of this end point
    -PK done throughout the study in Phase I and Phase II pre-dose and post-dose timepoints.
    -Progression and survival to be followed up to 24 months after first study drug dose (every 3 months)
    -ADA: aligned with PK sampling throughout the study.
    -AEs during the whole study
    -Response assessments for preliminary efficacy done at the end of cycle 1 to cycle 6, followed by every 3 months.
    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 No
    E.6.11Pharmacogenomic No
    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
    Dose escalation
    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 Yes
    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
    Dose escalation
    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 trial2
    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 concerned4
    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
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 171
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 172
    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 state137
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 343
    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)
    Medical records will be utilized for collection of survival data until 2 years from the first study treatment of all participants.
    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 Decision2021-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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