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    Summary
    EudraCT Number:2020-004870-22
    Sponsor's Protocol Code Number:AMB-051-02
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-11
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-004870-22
    A.3Full title of the trial
    A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects with Tenosynovial Giant Cell Tumor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects with Tenosynovial Giant Cell Tumor
    A.4.1Sponsor's protocol code numberAMB-051-02
    A.5.4Other Identifiers
    Name:US IND NUMBERNumber:100835
    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 organisationAmMax Bio., Inc.
    B.5.2Functional name of contact pointSenior Director, Clinical Operation
    B.5.3 Address:
    B.5.3.1Street Address555 Twin Dolphin Drive, Suite 610
    B.5.3.2Town/ cityRedwood City, CA
    B.5.3.3Post code94065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1(650) 492-9484
    B.5.5Fax number+1(650) 285-6564
    B.5.6E-mailtiffanynguyen@ammaxbio.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.3.1Product nameAMB-05X
    D.3.4Pharmaceutical form 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 INNnot yet assigned
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeAMB-05X
    D.3.9.3Other descriptive nameAMG 820
    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) No
    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
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10018253
    E.1.2Term Giant cell tumor of tendon sheath
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the safety, efficacy and PK of intravenous (IV) AMB-05X in the treatment of TGCT
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥18 years of age.
    2. Able to communicate well with study staff and understand and comply with the requirements of the study. Reads and voluntarily signs the informed consent form (ICF) and the Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) before the conduct of any study-specific procedures.
    3. TGCT that has been histologically confirmed by a pathologist. If the diagnosis has not been previously histologically confirmed, biopsy with histological confirmation is required before enrollment.
    4. Measurable disease as defined by RECIST v1.1 (except with a minimum size of 2 cm), assessed from MRI scans by a central radiologist.
    5. If subject uses prescription analgesic, subject must be on a stable prescription analgesic regimen during the 2 weeks before Baseline.
    6. Agrees to follow contraception guidelines.
    7. Adequate hematologic, hepatic, and renal function at Screening, defined by:
    • Absolute neutrophil count ≥ 1.5 × 109/L
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × upper limit of normal (ULN)
    • Hemoglobin > 10 g/dL
    • Total bilirubin ≤ 1.5 × ULN (elevated bilirubin secondary to a known, relatively benign condition [eg, Gilbert’s syndrome] is not exclusionary)
    • Platelet count ≥ 100 × 109/L
    • Serum creatinine ≤ 1.5 × ULN
    8. Willing and able to complete the PROMIS Physical Function Scale, Worst Stiffness NRS, BPI, and EQ-5D-5L throughout the study.
    E.4Principal exclusion criteria
    1. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) before Baseline.
    2. Use of pexidartinib, any other oral tyrosine kinbase inhibitor (eg, imatinib or nilotinib), or any biologic treatment targeting CSF1 or CSF1R within 3 months before Baseline.
    3. Current or prior radiotherapy within 3 months before Baseline.
    4. Current or prior active cancer within 3 years before 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.
    5. Known metastatic TGCT or malignant transformation of diffuse-type TGCT.
    6. Any history of complex or reconstructive surgery on the affected joint (eg, involving plates, screws, or metal implants).
    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 (TB).
    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 woman who is pregnant or breastfeeding. For women of childbearing potential, a positive pregnancy test at either Screening or Baseline will be exclusionary.
    11. A screening Fridericia-corrected QT interval (QTcF) ≥450 ms (men) or ≥470 ms (women)
    12. MRI contraindications (eg, pacemaker, loose metallic implants)
    13. History of hypersensitivity to any ingredient in the study drug.
    14. History of drug or alcohol abuse within 3 months before Baseline.
    15. Has 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. A person 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. A subject who, in the opinion of the Investigator, 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.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of reported treatment-emergent adverse events (TEAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    A Sponsor data monitoring committee (DMC) composed of qualified medical/clinical representatives from the Sponsor will review the available safety, tolerability, PK, pharmacodynamics (PD), and efficacy data on an ongoing basis and provide recommendations regarding appropriate next steps in study conduct. The DMC will pay special attention to any clinically significant adverse events (AEs).
    E.5.2Secondary end point(s)
    Efficacy
    The following efficacy endpoints will be assessed at Week 12:
    • Proportion of subjects who achieve an overall tumor response (objective response [OR], which includes both complete response [CR] and partial response [PR]) per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Eisenhauer, 2009)
    • Proportion of subjects with overall response based on tumor volume score (TVS), a TGCT-specific method that calculates tumor volume as a percentage of the estimated maximally distended synovial cavity
    • Mean change from Baseline in 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 Worst Pain NRS score
    • Mean change from Baseline in EQ-5D-5L health assessment
    Pharmacokinetics and Pharmacodynamics
    • Serum (and optional synovial) AMB-05X levels
    • Serum (and optional synovial) AMB-05X–binding anti-drug antibody (ADA) levels
    • Serum (and optional synovial) colony-stimulating factor 1 (CSF1) levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    The DMC will begin to review study data after the first 3 subjects complete Week 6 and will continue to review data throughout the study (each time 3 additional subjects [from any cohort] complete Week 12). Whenever a new dose is instituted during the study, the DMC will again review the available data once 3 subjects have completed Week 6 at the new dose.
    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 Yes
    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) 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 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 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 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
    Ukraine
    United States
    Germany
    Hungary
    Netherlands
    Poland
    Czechia
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 48
    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)
    Standard 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 Decision2021-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-20
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