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    Clinical Trial Results:
    An Adaptive, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects with Tenosynovial Giant Cell Tumor of the Knee

    Summary
    EudraCT number
    		 2020-003275-17
    Trial protocol
    		 PL   NL  
    Global end of trial date
    05 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2023
    First version publication date
    21 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AMB-051-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04731675
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 100835
    Sponsors
    Sponsor organisation name
    AmMax Bio, Inc.
    Sponsor organisation address
    555 Twin Dolphin Drive, Suite 610 , Redwood City,, United States, CA 94065
    Public contact
    Senior Director, Clinical Operation, AmMax Bio., Inc., +1 (650) 492-9484, tiffanynguyen@ammaxbio.com
    Scientific contact
    Chief Scientific Officer, AmMax Bio., Inc., +1 (650) 492-9484, kirkjohnson@ammaxbio.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
    21 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. Proportion who achieve an overall tumor response at Week 12 2. Proportion with overall response based on tumor volume score (TVS) 3. Mean change from Baseline in ROM 4. Mean change from Baseline in the PRO Measurement Information System Physical Function score 5. Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score 6. Percentage who respond with a decrease of at least 30% in mean Brief Pain Inventory score 7. Mean change from Baseline in BPI 8. Mean change from Baseline in Worst Pain NRS score 9. EQ-5D-5L Health Assessment 10. Serum and synovial CSF1 levels 11. Serum and synovial AMB-05X levels 12. Serum and synovial anti-AMB-05X antibody levels
    Protection of trial subjects
    Treated in routine care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ukraine: 1
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Netherlands: 8
    Worldwide total number of subjects
    11
    EEA total number of subjects
    8
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was from 2021-04-02 included Netherlands, United States and Ukraine

    Pre-assignment
    Screening details
    		 Number of Subjects Screened 19 (100.0%) Number of Subjects who Failed Screening 8 (42.1%) Number of Subjects Enrolled 11 (57.9%) Number of Subjects Dosed 11 (57.9%)

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

    Arms
    Arm title
    		 Single arm study
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    human monoclonal antibody against CSF1R
    Investigational medicinal product code
    AMB-05X,
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    The drug product was a sterile, clear, colorless to slightly yellow solution containing drug substance at a concentration of 70 mg/mL. Drug product was packaged in sterile 20-mL glass vials each containing a deliverable volume of 3.0 mL and stored frozen between -20 C and -70 C, protected from light. AMB-05X was administered via IA injection to the affected knee at a dose of either 150 mg or 90 mg drug substance.

    Number of subjects in period 1
    		Single arm study
    Started
    11
    Completed
    10
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Single arm study
    Reporting group description
    		 -

    Subject analysis set title
    Test set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Safety Efficacy PD/PK

    Primary: frequency and severity of reported TEAEs.

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    End point title
    		 frequency and severity of reported TEAEs. [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: It is a small single arm study based on descriptive statistics
    End point values
    		 Single arm study
    Number of subjects analysed
    11
    Units: reported TEAEs
    11
    No statistical analyses for this end point

    Secondary: Secondary endpoint

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    End point title
    		 Secondary endpoint
    End point description
    1.The proportion of subjects who achieve an overall tumor response (objective response[OR], which includes both complete response [CR] and partial response [PR]), per theResponse Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Eisenhauer,2009) at Week 12 2.Proportion of subjects with overall response based on TVS, a TGCT-specific method thatcalculates tumor volume as a percentage of the estimated maximally distended synovialactivity 3.Mean change from Baseline in ROM score 4.Mean change from Baseline in the PROMIS Physical Function score 5.Mean change from Baseline in Worst Stiffness NRS score 6.Percentage of subjects who respond with a decrease of at least 30% in mean BPI score 7.Mean change from Baseline in BPI 8.Mean change from Baseline in Worst Pain NRS score 9.EQ-5D-5L Health Assessment 10.Serum and synovial CSF1 levels 11.Serum and synovial AMB-05X levels 12.Serum and synovial anti-AMB-05X antibody levels
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Single arm study
    Number of subjects analysed
    11
    Units: proportion of subjects
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs will be recorded from the time the ICF is signed until the subject completes the last study visit or withdraws from the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    150 mg AMB-05X
    Reporting group description
    		 Subjects who received 150 mg AMB-05X.

    Reporting group title
    90 mg AMB-05X
    Reporting group description
    		 Subjects receiving subjects in the 90-mg dose

    Serious adverse events
    		 150 mg AMB-05X 90 mg AMB-05X
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 150 mg AMB-05X 90 mg AMB-05X
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    0 / 3 (0.00%)
    Vascular disorders
    Edema
         subjects affected / exposed
    6 / 8 (75.00%)
    0 / 3 (0.00%)
         occurrences all number
    6
    0
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Fatigue
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 8 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    Pruritus
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Disturbance in attention
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 8 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2021
    Version 2.1: In addition to integrating the country-specific changes made in Version 2.0 for Poland (Section 9.8.1.3) and Version 2.0 for Netherlands (Section 9.8.1.4) into the global protocol, the following major changes were made in global Version 2.1: Exclusion Criterion #2 was revised to allow previous use of pexidartinib, oral tyrosine kinase inhibitors, or any biologic treatment targeting CSF1 or CSF1R >3 months before Baseline. Use of pexidartinib, oral tyrosine kinase inhibitors, or biologic treatment targeting CSF1 or CSF1R within 3 months before Baseline remained exclusionary. Exclusion Criterion #3 was revised to exclude individuals with any history of reconstructive knee surgery in addition to the previously excluded history of extensive knee surgery. In addition, prior diagnostic synovectomy was not to be excluded if it was performed at least 3 months before Baseline, rather than the previous specification of at least 6 months before Baseline. This amendment was implemented after screening and treatment of some subjects had begun.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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