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    Summary
    EudraCT Number:2022-000101-28
    Sponsor's Protocol Code Number:AMB-051-07
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-03-06
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-000101-28
    A.3Full title of the trial
    A Phase 2, Open-Label, Adaptive, Dose-Ranging Study with Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects with Tenosynovial Giant Cell Tumor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tenosynovial Giant Cell Tumor is a rare, locally aggressive and destructive neoplasm (newly formed tissue) that arises in the synovium (joint fluid) of joints, bursae, or tendon sheaths. The Safety, Tolerability, Efficacy, and Pharmacokinetics (Totality of all processes to which a drug substance is subject in the body) of a new Antibody (part of the immune system) in the treatment of Tenosynovial Giant Cell Tumor shall be assessed in this trial.
    A.4.1Sponsor's protocol code numberAMB-051-07
    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 SponsorAmMax Bio, Inc.
    B.1.3.4CountryUnited States
    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 supportAmMax Bio, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegintel Ltd.
    B.5.2Functional name of contact pointMartin Breffini
    B.5.3 Address:
    B.5.3.1Street AddressTempletown
    B.5.3.2Town/ cityCarlingford, County Louth
    B.5.3.3Post codeA91 X097
    B.5.3.4CountryIreland
    B.5.6E-mailbmartin@regintel.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 AMB-05X
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMB-05X
    D.3.9.3Other descriptive nameAMB-05X
    D.3.9.4EV Substance CodeSUB218369
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    Tenosynovial Giant Cell Tumor
    E.1.1.1Medical condition in easily understood language
    Tenosynovial Giant Cell Tumor is a rare, locally aggressive and destructive neoplasm (newly formed tissue) that arises in the synovium (joint fluid) of joints, bursae, or tendon sheaths
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084212
    E.1.2Term Pigmented villonodular synovitis
    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
    The objectives of this study are to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of intra-articular (IA) AMB-05X in the treatment of tenosynovial giant cell tumor (TGCT), both after an initial 24 weeks of treatment (Part 1) and after extended treatment or observation (Part 2).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Enrollment into Part 1
    1. Has never received AMB-05X in another study.
    2. Male or female ≥18 years of age.
    3. Able to understand and willing to adhere to the requirements of this study. Voluntarily signs the ICF before the conduct of any study-specific procedures.
    4. TGCT with only 1 joint involvement that has been diagnosed histologically by a pathologist and documented. If a histological diagnosis has not been made previously, biopsy with histological diagnosis is required before enrollment.
    a. Individuals with TGCT of the knee joint are eligible. Depending on results in Cohort A and the recommendations of the DMC, individuals with TGCT of the hip and shoulder joint may also be allowed after Cohort A.
    b. Individuals with TGCT that are amenable or non-amenable to surgery are eligible.
    5. Measurable disease of at least 1 cm per RECIST v1.1, assessed from MRI scans by central radiology review.
    6. If the subject uses prescription analgesic, subject must be on a stable prescription analgesic regimen during the 2 weeks before Baseline.
    7. Agrees to follow contraception guidelines
    8. Adequate hematologic, hepatic, and renal function at Screening
    9. Symptomatic TGCT defined as at least 1 of the following:
    a. A BPI worst pain score of at least 4 before dosing at Baseline.
    b. A Worst Stiffness NRS score of at least 4 before dosing at Baseline.

    Inclusion Criteria for Enrollment into Part 2 without Completing Part 1
    1. Have measurable disease of at least 1 cm per RECIST v1.1, assessed from MRI scans by central radiology review, assessed from MRI scans by central radiology review, and received treatment in Study AMB-051-01.
    2. Able to understand and willing to adhere to the requirements of this study. Voluntarily signs the ICF before the conduct of any study-specific procedures.
    3. Agrees to follow contraception guidelines
    4. Adequate hematologic, hepatic, and renal function at Screening
    5. Symptomatic TGCT defined as at least 1 of the following:
    a. A BPI worst pain score of at least 4 before dosing at Baseline.
    b. A Worst Stiffness NRS score of at least 4 before dosing at Baseline.
    E.4Principal exclusion criteria
    1. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) before Study Baseline (other than AMB-05X in a previous study for individuals enrolling directly into Part 2).
    2. Use of any of the following:
    a. pPexidartinib, any other oral tyrosine kinase inhibitor (eg, imatinib or nilotinib), or any biologic treatment targeting CSF1 or CSF1R (except AMB-05X), within 3 months before the Study Baseline visit
    b. Current or recent (within 10 days before starting study treatment) full-dose oral anticoagulants (eg, warfarin), daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day).
    3. History of extensive or reconstructive surgery on the affected joint (eg, involving plates, screws, or metal implants). A history of prior diagnostic or partial synovectomy is not exclusionary if performed at least 3 months before Study Baseline.
    4. Current or prior radiotherapy within 3 months before Study Baseline.
    5. Current or prior active cancer within 3 years before Study Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy), except adequately treated basal or squamous cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix or breast, or prostate carcinoma not requiring treatment apart from active surveillance.
    6. Known metastatic TGCT or malignant transformation of TGCT.
    7. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immunodeficiency virus (HIV).
    8. Known active Tuberculosis.
    9. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with the subject’s study participation or the interpretation of the subject’s results.
    10. A female who is pregnant or breastfeeding. For females of childbearing potential, a positive pregnancy test at either Screening or Study Baseline will be exclusionary.
    11. A screening QT interval corrected using Fridericia’s formula (QTcF) ≥ 470 ms
    12. MRI contraindications
    13. History of hypersensitivity to any ingredient in the study drug.
    14. History of drug or alcohol abuse within 3 months before Study Baseline.
    15. Any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment, interfere with interpretation of study results, or, in the Investigator’s opinion, make the subject inappropriate for this study.
    16. An individual who is held in detention as the result of a judicial or official decision or who is in a subordinate relationship to the Sponsor or Investigator.
    17. An individual who, in the Investigator’s opinion, should not participate in this study for any reason, including instances where the subject’s stability or ability to comply with study requirements is in question
    18. Subjects with TGCT that is only extra-articular by MRI.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects who achieve an objective response (OR) (objective response rate [ORR]) by central radiology review (which includes both complete response [CR] and partial response [PR]) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Eisenhauer, 2009) at Week 24 for Part 1
    • Frequency and severity of reported treatment-emergent adverse events (TEAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24 (part 1) and after extended treatment or observation (part 2).
    E.5.2Secondary end point(s)
    Efficacy
    The following secondary endpoints will be evaluated for Part 1 and Part 2, unless otherwise stated:
    • Proportion of subjects who achieve an OR (ORR) by central radiology review (which includes both complete response [CR] and partial response [PR]) per RECIST v1.1 (for Part 2 only)
    • Proportion of subjects who were re-treated with AMB-05X (ie, subjects entering the study from Study AMB-051-01) who achieve an OR (ORR) by central radiology review (which includes both CR and PR) per RECIST v1.1 (for Part 2 only)
    • Proportion of subjects who achieve an OR (which includes both CR and PR) per modified RECIST (Peterfy, 2017)
    • Proportion of subjects who achieve an OR per tumor volume score (TVS), a TGCT-specific method that calculates tumor volume as a percentage of the estimated maximally distended synovial cavity (Tap, 2015)
    • Median duration of response per RECIST v1.1, modified RECIST, and TVS
    • Time to response (TTR) per RECIST v1.1, modified RECIST, and TVS
    • Mean change from Baseline in joint range of motion (ROM) score
    • Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score
    • Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score
    • Percentage of subjects who respond with a decrease of at least 30% in mean Brief Pain Inventory (BPI) score from Baseline
    • Mean change from Baseline in BPI score
    • Mean change from Baseline in PROMIS Pain Interference score
    • Mean change from Baseline in Patient Global Impression of Change (PGIC) in Physical Functioning for capacity to perform everyday tasks
    • Mean change from Baseline in PGIC in TGCT-related stiffness score
    • Mean change from Baseline in Worst Pain NRS score
    • Mean change from Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) health assessment

    Pharmacokinetic and Pharmacodynamic Secondary Outcome Measures
    - Serum and synovial AMB-05X levels
    - Serum and synovial ADA levels against AMB-05X
    - Serum and synovial CSF1 levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    After extended treatment or observation (part 2).
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.1.1First administration to humans No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Australia
    United States
    Czechia
    France
    Italy
    Netherlands
    Poland
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 84
    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)
    Patients who have finished the clinical trial will receive standard of care treatment.
    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 Decision2023-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
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