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    Summary
    EudraCT Number:2021-002635-35
    Sponsor's Protocol Code Number:Ph2_INBRX-109_SA_CS
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2022-01-10
    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 ConcernedIreland - HPRA
    A.2EudraCT number2021-002635-35
    A.3Full title of the trial
    A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 study of INBRX-109 in adults with an unresectable or metastasized cancer of the bones and joints (Chondrosarcoma).
    A.4.1Sponsor's protocol code numberPh2_INBRX-109_SA_CS
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04950075
    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 SponsorInhibrx, 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 supportInhibrx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInhibrx, Inc.
    B.5.2Functional name of contact pointClinical Program Manager
    B.5.3 Address:
    B.5.3.1Street Address11025 North Torrey Pines Road, Suite 140
    B.5.3.2Town/ cityLa Jolla, CA
    B.5.3.3Post code92037
    B.5.3.4CountryUnited States
    B.5.4Telephone number001919-667-3242
    B.5.6E-mailmichelle@inhibrx.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 INBRX-109
    D.3.4Pharmaceutical form Lyophilisate for 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 available
    D.3.9.2Current sponsor codeINBRX-109
    D.3.9.3Other descriptive nameRecombinant humanized IgG1 antibody targeting human TRAIL death receptor 5 (DR5).
    D.3.9.4EV Substance CodeSUB235398
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable or metastatic conventional chondrosarcoma
    E.1.1.1Medical condition in easily understood language
    Malignant bone tumor that cannot be resected or it has been spread from the primary site (place where it started) to other places in the body.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10008734
    E.1.2Term Chondrosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the anticancer efficacy of INBRX-109 in the Intention To Treat (ITT) population as measured by PFS per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo.
    E.2.2Secondary objectives of the trial
    Evaluate:
    • Anticancer efficacy of INBRX-109 as measured by overall survival (OS) comparing INBRX-109 and placebo.
    • Anticancer efficacy of INBRX-109 as measured by objective response rate (ORR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
    • Anticancer efficacy of INBRX-109 as measured by PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo
    • QoL, as measured by EORTC QLQ-C30, Pain and Physical Functioning scales, comparing INBRX-109 and placebo
    • Anticancer efficacy of INBRX-109 as measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
    • DOR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo.
    • Safety and tolerability of INBRX-109
    • Characterize the pharmacokinetics (PK) of INBRX-109
    • Frequency of ADA, and neutralizing ADA (NAb), against INBRX-109 and to explore the potential relationship with safety, PK and efficacy of INBRX-109
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females aged ≥ 18 years to ≤ 85 years
    2. Conventional chondrosarcoma, unresectable (i.e., not amenable to tumor resection with curative intent) or metastatic.
    3. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
    4. Evidence of confirmed radiographic disease progression per RECISTv1.1 criteria within 6 months prior to screening for this study.
    5. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
    6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
    7. Estimated life expectancy of at least 12 weeks.
    8. Male and female patients of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate), from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study treatment.
    E.4Principal exclusion criteria
    1. Any prior exposure to DR5 agonists.
    2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
    3. Receipt of any anti-cancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment, whichever is longer for biologics, and whichever is shorter.
    Note: patients who received pazopanib as an immediate prior line, must have a 4 week washout and no evidence of prior or residual hepatotoxicity.
    Note: patients with any history or evidence of Grade ≥3 hepatotoxicity on prior anti-cancer therapy are excluded.
    4.Receipt of radiotherapy (with the exception of palliative localized radiation) within 4 weeks to the first dose of study treatment. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
    Note: 1-week washout is required for palliative radiation to non-CNS disease.
    Note: patients who had prior radiotherapy involving the liver (total calculated dose to the liver >10Gy) are excluded.
    5. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
    6. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
    7. Chronic liver diseases including but not limited to non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), alcohol-related liver disease, cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, liver hemangioma, hepatic or biliary autoimmune disorders (e.g., primary biliary cholangitis, autoimmune hepatitis), history of portal or hepatic vein thrombosis, sinusoidal occlusion syndrome.
    Note: Patients with any imaging evidence of NAFLD, NASH, fibrosis, or cirrhosis, regardless of prior history and LFTs at baseline are excluded from the study (liver MRI or MRE are preferred, other imaging modalities, such as CT [with contrast], ultrasound, transient elastography, are acceptable).
    Exception: Patients aged < 45 years with NAFLD detected by imaging may participate in the study if adequate hepatic function as defined in the inclusion criteria is confirmed. Note: Patients aged > 65 years with non-alcoholic fatty liver disease (NAFLD) are excluded from the study.
    Note: Patients aged > 65 ≥45 years with NAFLD are excluded from the study.
    8. Patients aged ≥ 65 years and with BMI ≥ 30 kg/m2 and/or patients aged ≥45 years with HSI ≥36 or FLI ≥60 are excluded from the study.
    9. Any evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
    10. Other exclusion criteria per protocol.
    E.5 End points
    E.5.1Primary end point(s)
    • Progression Free Survival (PFS) per RECISTv1.1 assessed by central IRR in the ITT population
    E.5.1.1Timepoint(s) of evaluation of this end point
    From study start until the end of the study.
    E.5.2Secondary end point(s)
    • Overall Survival (OS)
    • Objective Response Rate (ORR) per RECISTv1.1 by real-time Independent Radiology Review (IRR)
    • Progression Free Survival (PFS) per RECISTv1.1 by Investigator assessment
    • Quality of Life (QoL) per EORTC QLQ-C30 (Pain and Physical function)
    • Disease Control Rate (DCR) per RECISTv1.1 by real-time IRR
    • Duration of Response (DOR) per RECISTv1.1 by real-time IRR
    • Treatment-Emergent Adverse Event (TEAEs) including SAEs
    • PK characterization: AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit
    • Frequency of Anti-Drug Antibodies (ADA) and neutralizing ADA (NAb)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • OS: from study start until the end of the study (EoS)
    • PFS: until DP
    • QoL: from study start until EoS
    • ORR and DOR per RECISTv1.1 by IRR: until Disease Progression (DP)
    • DCR: until DP
    • TEAEs including SAEs: from study start until EoS.
    • PK characterization: from study start until EoS
    • ADA and NAb: from study start until EoS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Ireland
    Australia
    France
    Germany
    Italy
    Korea, Republic of
    Netherlands
    Spain
    Turkey
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 151
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 201
    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)
    For patients on placebo arm: Patients who experience documented disease progression verified by central IRR review will have their treatment assignment unblinded and will be able to crossover to open-label INBRX-109 if they were on the placebo study arm.
    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 Decision2022-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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