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    Clinical Trial Results:
    A pilot study to assess the safety, tolerability, dose-finding, and efficacy of iadademstat in combination with azacitidine in adult patients with Acute Myeloid Leukemia (AML) in first-line therapy.

    Summary
    EudraCT number
    		 2018-000482-36
    Trial protocol
    		 ES  
    Global end of trial date
    30 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2024
    First version publication date
    16 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL02-ORY-1001AML
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oryzon Genomics S. A.
    Sponsor organisation address
    Carrer de Sant Ferran, 74, CORNELLA DE LLOBREGAT, Spain, 08940
    Public contact
    Douglas V. Faller, Oryzon Genomics S. A., 34 93 515 13 13, dfaller@oryzon.com
    Scientific contact
    Douglas V. Faller, Oryzon Genomics S. A., 34 93 515 13 13, dfaller@oryzon.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To asses safety, tolerability and dose finding of ORY-1001 in combination with azacitidine.
    Protection of trial subjects
    The protocol and informed consent forms were submitted to an Independent Ethics Committee (IEC) for review and approval before study initiation. All revisions to the informed consent forms (if applicable) after initial IEC approval were submitted to the IEC for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was an open-label study. Patient enrollment to a particular dose was in accordance with a Patient Allocation and Recruitment Process. The Sponsor was the responsible for allocation of dose cohort and patient numbers.

    Pre-assignment
    Screening details
    		 The screening period consisted of 14-day period after the ICF signature. During this screening period study procedures for subject selection were completed (e.g., inclusion/exclusion criteria, disease assessment, medical history, demographics, concomitant medication, vital signs including ECG...)

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 90 mcg/m2/d
    Arm description
    		 Starting dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The dosage of Azacitidine was 75 mg/m2 for 7 days (7 consecutive days or days 1-5, 8, 9). Iadademstat 90 mcg/m2/d orally intake, in a 5 days on/2 day off schedule, 4-weeks cycles

    Arm title
    		 60 mcg/m2/d
    Arm description
    		 De-escalation dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The dosage of Azacitidine was 75 mg/m2 for 7 days (7 consecutive days or days 1-5, 8, 9). Iadademstat 60 mcg/m2/d orally intake, in a 5 days on/2 day off schedule, 4-weeks cycles

    Number of subjects in period 1
    		90 mcg/m2/d 60 mcg/m2/d
    Started
    19
    17
    Completed
    18
    16
    Not completed
    1
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 36 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 36 36
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 18 18
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set (SAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The SAS is defined as all patients who received at least one dose of the study treatment. SAS was used for all safety analyses.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who met eligibility criteria and have been treated. FAS has been used for sensitivity analyses, including safety analysis and efficacy analysis.

    Subject analysis set title
    Efficacy Analysis Set (EAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The EAS is defined as all patients who met the eligibility criteria, have been treated, have baseline disease assessment, and have at least 1 available post-baseline efficacy assessment. EAS has been used for the efficacy analyses.

    Subject analysis sets values
    		 Safety Analysis Set (SAS) Full Analysis Set (FAS) Efficacy Analysis Set (EAS)
    Number of subjects
    36
    34
    27
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    36
    34
    27
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    18
    18
    14
        Male
    18
    16
    13

    End points

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    End points reporting groups
    Reporting group title
    90 mcg/m2/d
    Reporting group description
    		 Starting dose

    Reporting group title
    60 mcg/m2/d
    Reporting group description
    		 De-escalation dose

    Subject analysis set title
    Safety Analysis Set (SAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The SAS is defined as all patients who received at least one dose of the study treatment. SAS was used for all safety analyses.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who met eligibility criteria and have been treated. FAS has been used for sensitivity analyses, including safety analysis and efficacy analysis.

    Subject analysis set title
    Efficacy Analysis Set (EAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The EAS is defined as all patients who met the eligibility criteria, have been treated, have baseline disease assessment, and have at least 1 available post-baseline efficacy assessment. EAS has been used for the efficacy analyses.

    Primary: Safety of iadademstat in combination with azacitidine

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    End point title
    		 Safety of iadademstat in combination with azacitidine
    End point description
    End point type
    Primary
    End point timeframe
    Treatment period in both arms of the study
    End point values
    		 90 mcg/m2/d 60 mcg/m2/d Safety Analysis Set (SAS)
    Number of subjects analysed
    19
    17
    36
    Units: Subjects
        Subjects with AEs
    19
    17
    36
        Subjects with SAEs
    18
    16
    34
        Subjects with AEs ≥G3
    19
    17
    36
        Subjects with AEs leading to drug interrupted
    7
    5
    12
        Subjects with Fatal AEs
    8
    4
    12
        Subjects with ADRs
    17
    16
    33
        Subjects with SADRs
    2
    1
    3
        Subjects with ADRs ≥G3
    16
    15
    31
        Subjects with ADRs leading to drug interrupted
    2
    0
    2
        Subjects with Fatal ADRs
    1
    0
    1
    Statistical analysis title
    		 Descriptive statistics
    Comparison groups
    90 mcg/m2/d v 60 mcg/m2/d
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 Descriptive statistics
    Confidence interval
    Notes
    [1] - Descriptive statistics
    [2] - Not applicable. Descriptive statistics.

    Secondary: Individual Patients Response

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    End point title
    		 Individual Patients Response
    End point description
    Responses per investigator assessment (European LeukemiaNet 2010 criteria) of the 27 patients in the Efficacy Analysis Set
    End point type
    Secondary
    End point timeframe
    Treatment period
    End point values
    		 90 mcg/m2/d 60 mcg/m2/d Efficacy Analysis Set (EAS)
    Number of subjects analysed
    14
    13
    27
    Units: Subjects
        CR
    5
    4
    9
        CRi
    4
    1
    5
        PR
    2
    6
    8
        SD
    2
    2
    4
        PD
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR: Percentage of subjects archiving complete remission (CR), CR with incomplete recovery (CRi), partial response (PR), confirmed by repeat assessments ≥4 weeks after initial documentation
    End point type
    Secondary
    End point timeframe
    Treatment period
    End point values
    		 90 mcg/m2/d 60 mcg/m2/d Efficacy Analysis Set (EAS)
    Number of subjects analysed
    14
    13
    27
    Units: Subjects
    number (confidence interval 95%)
        Objective response (%; 95% CI)
    79 (49 to 95)
    85 (55 to 98)
    82 (62 to 94)
    No statistical analyses for this end point

    Secondary: Time to response (TTR)

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    End point title
    		 Time to response (TTR)
    End point description
    TTR defined as time from the start of treatment with iadademstat to the firts objective tumor response observed in terms of number of cycles administrated.
    End point type
    Secondary
    End point timeframe
    Treatment period
    End point values
    		 90 mcg/m2/d 60 mcg/m2/d Efficacy Analysis Set (EAS)
    Number of subjects analysed
    14
    13
    27
    Units: day
    number (confidence interval 95%)
        Time to first response, days (95% CI)
    67 (30 to 93)
    43 (29 to 80)
    64 (32 to 80)
        Time to best response, days (95% CI)
    124 (67 to 169)
    79 (32 to 283)
    105 (67 to 162)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR: defined as the time from the first occurrence of a documented tumor response to the time of progression or death from any cause, whichever occurs first. (DOR analysis only included responders).
    End point type
    Secondary
    End point timeframe
    Treatment and follow up period
    End point values
    		 90 mcg/m2/d 60 mcg/m2/d Efficacy Analysis Set (EAS)
    Number of subjects analysed
    14
    13
    27
    Units: day
    number (confidence interval 95%)
        CR + CRi + PR, days (95% CI)
    282 (16 to 529)
    205 (71 to 748)
    269 (86 to 529)
    No statistical analyses for this end point

    Secondary: Event-Free survival (EFS)

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    End point title
    		 Event-Free survival (EFS)
    End point description
    EFS: Time from first study treatment to disease progression or death.
    End point type
    Secondary
    End point timeframe
    Study period
    End point values
    		 90 mcg/m2/d 60 mcg/m2/d Efficacy Analysis Set (EAS)
    Number of subjects analysed
    14
    13
    27
    Units: month
    median (confidence interval 95%)
        EFS (mos) (95% CI)
    10.2 (2.0 to 19.4)
    7.7 (3.4 to 21.9)
    8.9 (3.4 to 11.8)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS: Time from first study treatment to death from any cause.
    End point type
    Secondary
    End point timeframe
    Study period
    End point values
    		 Efficacy Analysis Set (EAS)
    Number of subjects analysed
    27
    Units: month
    median (confidence interval 95%)
        OS (mos) (95% CI)
    11.1 (4.5 to 29.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period
    Adverse event reporting additional description
    Any adverse event G3 or more with a frequency threshold of at least 5% and all adverse events G3 or more related to iadademstat (+/- azacitidine) Any serious adverse event with a frequency threshold of at least 5% and all serious adverse events related to iadademstat (+/- azacitidine)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Safety analysis set
    Reporting group description
    		 -

    Serious adverse events
    		 Safety analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    34 / 36 (94.44%)
         number of deaths (all causes)
    12
         number of deaths resulting from adverse events
    12
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Differentiation syndrome
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    14 / 36 (38.89%)
         occurrences causally related to treatment / all
    1 / 18
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 36 (11.11%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    COVID-19 pneumonia
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Sepsis
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin infection
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Fungal infection
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 36 (100.00%)
    Investigations
    Platelet count decreased
         subjects affected / exposed
    32 / 36 (88.89%)
         occurrences all number
    191
    Neutrophil count decreased
         subjects affected / exposed
    24 / 36 (66.67%)
         occurrences all number
    162
    Haemoglobin abnormal
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    5
    White blood cell count decreased
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    5
    White blood cell count abnormal
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    5
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Lymphocyte count abnormal
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Haemoglobin decreased
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    3
    Weight decreased
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    1
    Alanine aminotransferase abnormal
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    1
    Aspartate aminotransferase abnormal
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    1
    Blood sodium increased
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Differentiation syndrome
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3
    Nervous system disorders
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Dysgeusia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    24 / 36 (66.67%)
         occurrences all number
    58
    Febrile neutropenia
         subjects affected / exposed
    17 / 36 (47.22%)
         occurrences all number
    24
    Leukocytosis
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences all number
    5
    Fatigue
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    3
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    3
    Cellulitis
         subjects affected / exposed
    4 / 36 (11.11%)
         occurrences all number
    4
    Pneumonia
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences all number
    5
    Respiratory tract infection
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    COVID-19 pneumonia
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3
    Sepsis
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3
    Skin infection
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Septic shock
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Abscess
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2019
    Add the determination of minimal residual disease (MRD). Add additional timepoints to peripheral blood smears evaluation. Add 2 more specific biomarkers for the evaluation of gene expression changes: HBA1 and GYPB).
    22 Oct 2019
    Add Guide for management of patient’s hematological toxicity. Update of participant sites.
    06 Oct 2020
    Inclusion criteria 1 and 3 have been amended (and title modified in line with that). To include patients ≥ 18 years unfit for intensive chemotherapy and clarify prior treatments allowed
    15 Feb 2021
    Exclusion criteria 10 has been amended. To include the request that all patients should initiate antibacterial, antiviral and antifungal prophylaxis simultaneously with the start of the study treatment and irrespective of the neutrophil count
    02 Jun 2021
    Back to initial RP2D of 90 µg/m2/d and recommendation for dose modification in case of neutropenia and/or thrombocytopenia is revised accordingly. To achieve quicker responses after the first cycles of treatment. Provide guidance to modify treatment dosing based on hematological toxicity.
    17 May 2022
    Set an End of Study date: 30 Sep 2022

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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