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    Summary
    EudraCT Number:2020-003275-17
    Sponsor's Protocol Code Number:AMB-051-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-003275-17
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.4.1Sponsor's protocol code numberAMB-051-01
    A.5.4Other Identifiers
    Name:IND NUMBERNumber:151382
    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 injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular 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.3.9.4EV Substance CodeSUB183864
    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 of the Knee
    E.1.1.1Medical condition in easily understood language
    Tenosynovial Giant Cell Tumor of the Knee
    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
    safety and efficacy of AMB-05Xpost intra-articular injection of 150 mg biweekly for up to 12 weeks 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. Subject ≥ 18 years must be able to communicate well with study staff, understand and comply with the requirements of the study, and read and voluntarily sign the ICF and the Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable, prior to the conduct of any study-specific procedures.
    2. A diagnosis of TGCT of the knee joint, that has been histologically confirmed either by a pathologist at the treating institution or by a central pathologist. If not previously confirmed, biopsy with histological confirmation is required.
    3. Measurable disease of at least 1 cm and based on RECIST v1.1 (Eisenhauer, 2009) assessed from MRI scans by a central radiologist. Subjects with one knee joint involvement only, and only limited posterior extra-articular nodular TGCT lesions as assessed by central radiologist and tumor review committee.
    4. Stable prescription of analgesic regimen during the 2 weeks before Baseline
    5. Negative urine drug screen (UDS) at Screening and Baseline
    6. Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline
    7. Agrees to follow contraception guidelines (see Section 5.3)
    8. Adequate hematologic, hepatic, and renal function, at Screening visit, defined by:
    • Absolute neutrophil count ≥ 1.5 × 109/L
    • Aspartate aminotransferase or alanine aminotransferase (AST or ALT) ≤ 1.5 × upper limit of normal (ULN)
    • Hemoglobin > 10 g/dL
    • Total bilirubin ≤ 1.5 × ULN
    • Platelet count ≥ 100 × 109/L
    • Serum creatinine ≤ 1.5 × ULN
    9. Willing and able to complete the BPI, Worst Stiffness NRS item, PROMIS Physical Function Scale, EQ-5D-5L, and other self-assessment instruments throughout the study
    E.4Principal exclusion criteria
    1. Prior investigational drug use within 4 weeks or 5 half-lives (whichever is longer) before Baseline
    2. Previous use of pexidartinib, any biologic treatment targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors (e.g., imatinib or nilotinib).
    3. History of extensive knee surgery; except for prior diagnostic synovectomy which is not exclusionary if at least 6 months prior to baseline
    4. Active cancer (either currently or within 1 year before Baseline) that requires therapy (e.g., surgery, chemotherapy, or radiation therapy), with the exception of 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
    6. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immunodeficiency virus (HIV)
    7. Known active tuberculosis
    8. 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 his or her results
    9. Women who are breastfeeding
    10. A screening Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
    11. MRI contraindications (e.g., pacemaker, loose metallic implants)
    12. History of hypersensitivity to any ingredient of the study drug
    13. History of drug or alcohol abuse within 3 months before the first dose of study drug
    14. 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 or interfere with interpretation of study results and, in the Investigator’s opinion, make the subject inappropriate for this study
    15. Subjects who, in the Investigator’s opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements
    E.5 End points
    E.5.1Primary end point(s)
    1. Frequency and severity of reported treatment-emergent adverse events (TEAEs)
    2. The 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)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1. 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 activity
    2. Mean change from Baseline in range of motion (ROM) score
    3. Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score
    4. Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score
    5. Percentage of subjects who respond with a decrease of at least 30% in mean Brief Pain Inventory (BPI) score
    6. Mean change from Baseline in BPI
    7. Mean change from Baseline in Worst Pain NRS score
    8. EQ-5D-5L Health Assessment
    9. Serum and synovial CSF1 levels
    10. Serum and synovial AMB-05X levels
    11. Serum and synovial anti-AMB-05X antibody levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluations will be done every 3 months during the study, at the Data Monitoring Committee Meetings
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Netherlands
    Poland
    Ukraine
    United States
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 12
    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)
    Normal 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 Decision2021-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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