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    Summary
    EudraCT Number:2022-000135-23
    Sponsor's Protocol Code Number:BA3011-002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-000135-23
    A.3Full title of the trial
    A Phase 2 Study of Mecbotamab Vedotin (BA3011) Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer Who Had Prior Disease Progression On or Are Intolerant to a PD-1/L1, EGFR, or ALK Inhibitor
    Studio di fase II su mecbotamab vedotin (BA3011) in monoterapia e in associazione a nivolumab in pazienti adulti affetti da carcinoma polmonare non a piccole cellule metastatico con precedente progressione della malattia in corso di terapia con un inibitore di PD-1/L1, di EGFR o di ALK oppure intolleranti a tali terapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer
    Studio di fase ii su BA3011 in monoterapia o in combinazione con Nivolumabin pazienti adulti affetti da carcinoma polmonare non a piccole cellule metastatico
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberBA3011-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04681131
    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 SponsorBioAtla 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 supportBioAtla Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioAtla Inc.
    B.5.2Functional name of contact pointJi Hwan Lee
    B.5.3 Address:
    B.5.3.1Street Address11085 Torreyana Rd, Suite 100
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018585580708
    B.5.6E-mailClinicaltrials@bioatla.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 nameMecbotamab Vedotin
    D.3.2Product code [BA3011]
    D.3.4Pharmaceutical form Solution for injection/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.3.9.1CAS number 2460400-28-4
    D.3.9.2Current sponsor codeBA3011
    D.3.9.4EV Substance CodeSUB253534
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name OPDIVO
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG AIC No. EU/1/15/1014/003
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    D.3.2Product code [BMS-936558]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 3
    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 Yes
    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 name-
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNpegfilgrastim
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Non-Small Cell Lung Cancer
    Carcinoma polmonare non a piccole cellule metastatico
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cancro ai polmoni
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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 assess antitumor activity of BA3011 alone and in combination with nivolumab.
    • To assess the safety of BA3011 alone and in combination with nivolumab.
    • Valutare l'attività antitumorale di BA3011 da solo e in combinazione con nivolumab.
    • Valutare la sicurezza di BA3011 da solo e in combinazione con nivolumab.
    E.2.2Secondary objectives of the trial
    • To further characterize the clinical activity of BA3011 alone and in combination with nivolumab.

    Exploratory:
    • To assess the pharmacokinetics (PK) of BA3011 alone and in combination with nivolumab.
    • To evaluate the immunogenicity of BA3011 alone and in combination with nivolumab.
    • To further explore the relationship between tumor AXL status and clinical response to BA3011.
    • To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3011.
    - Caratterizzare ulteriormente l'attività clinica di BA3011 da solo e in combinazione con nivolumab.

    Esplorativo:
    - Valutare la farmacocinetica (PK) di BA3011 da solo e in combinazione con nivolumab.
    - Valutare l'immunogenicità di BA3011 da solo e in combinazione con nivolumab.
    - Esplorare ulteriormente la relazione tra lo stato di AXL del tumore e la risposta clinica a BA3011.
    - Valutare potenziali biomarcatori tumorali ed ematici candidati alla selezione dei pazienti o alla correlazione con l'attività antitumorale di BA3011.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have histologically or cytologically confirmed locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC).
    - Age >= 18 Year.
    - Adequate renal function.
    - Adequate liver function.
    - Adequate hematological function
    - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    - Life expectancy of at least three months
    - Avere un carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato, non resecabile o metastatico, confermato istologicamente o citologicamente.
    - Età >= 18 anni.
    - Funzionalità renale adeguata.
    - Adeguata funzionalità epatica.
    - Funzione ematologica adeguata.
    - Avere un performance status di 0 o 1 dell'Eastern Cooperative Oncology Group (ECOG).
    - Aspettativa di vita di almeno tre mesi
    E.4Principal exclusion criteria
    - Clinically significant cardiac disease.
    - Known non-controlled central nervous
    - Known non-controlled central nervous system (CNS) metastasis.
    - Prior therapy with a conjugated or unconjugated auristatin derivative / vinca-binding site targeting payload.
    - A history of = > Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
    - Major surgery within 4 weeks before first BA3011 administration.
    - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
    - Women who are pregnant or breast feeding
    - Malattia cardiaca clinicamente significativa.
    - Metastasi del sistema nervoso centrale (SNC) non controllate.
    - Terapia precedente con un derivato dell'auristatina coniugato o non coniugato / carico utile mirato al sito di legame della vinca.
    - Anamnesi di reazioni allergiche di grado = 3 o maggiore alla terapia con mAb, nonché allergia o intolleranza nota o sospetta a qualsiasi agente somministrato durante questo studio.
    - Intervento chirurgico maggiore nelle 4 settimane precedenti la prima somministrazione di BA3011.
    - Anamnesi nota di positività al virus dell'immunodeficienza umana (HIV) o sindrome da immunodeficienza acquisita (AIDS).
    - Donne in gravidanza o in fase di allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: objective response rate (ORR).

    Safety: AEs, serious adverse events (SAEs), and changes from baseline in laboratory parameters and vital signs.
    Efficacia: tasso di risposta obiettiva (ORR).

    Sicurezza: AEs, eventi avversi gravi (SAEs) e variazioni rispetto al basale dei parametri di laboratorio e dei segni vitali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Objective response rate (ORR) is defined as the proportion of subjects with a best overall response of confirmed CR or confirmed PR that occur prior to the initiation of subsequent anticancer treatment.
    Il tasso di risposta obiettiva (ORR) è definito come la proporzione di soggetti con una migliore risposta globale di CR o PR confermata che si verifica prima dell'inizio di un successivo trattamento antitumorale
    E.5.2Secondary end point(s)
    Efficacy:
    o Duration of response (DOR)
    o Progression-free survival (PFS)
    o Best overall response (OR)
    o Disease control rate (DCR)
    o Time to response (TTR)
    o Overall survival (OS)
    o Percent change from baseline in target lesion sum of diameters
    Efficacia:
    o Durata della risposta (DOR)
    o Sopravvivenza libera da progressione (PFS)
    o Migliore risposta globale (OR)
    o Tasso di controllo della malattia (DCR)
    o Tempo alla risposta (TTR)
    o Sopravvivenza globale (OS)
    o Variazione percentuale rispetto al basale della somma dei diametri delle lesioni bersaglio
    E.5.2.1Timepoint(s) of evaluation of this end point
    DOR is defined as the time from the first documented OR until the first documented disease progression or death, whichever occurs first. PFS is defined as the time from the first dose of IP until the first documentation of disease progression or death. BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy. DCR is defined as the proportion of pts with a best overall response of confirmed CR, confirmed PR, or stable disease (SD)= 12 weeks. Duration of SD is defined as the time from the first dose of IP until the first documentation of disease progression or death. TTR is defined as the time from the first dose of IP until the first documentation of OR. OS is defined as the time from the first dose of BA3021 until death.
    DOR è tempo trascorso da prima OR documentata fino a prima progressione di malattia documentata o al decesso, a seconda di quale si verifica prima. PFS è il tempo trascorso da prima dose di IP a prima documentazione progressione della malattia o morte. BOR si baserà su tutte le valutazioni della malattia post-baseline che si verificano prima dell'inizio di successiva terapia antitumorale. DCR è la proporzione di pazienti con migliore risposta globale CR confermata, PR confermata o malattia stabile (SD)= 12 sett. Durata SD è tempo trascorso da prima dose di IP a prima documentazione progressione malattia o di morte. TTR è definita come il tempo trascorso dalla prima dose di IP alla prima documentazione di OR. La OS è definita come il tempo trascorso dalla prima dose di BA3021 al decesso.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hong Kong
    Taiwan
    United States
    France
    Poland
    Spain
    Germany
    Greece
    Italy
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 134
    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)
    as per standard of care
    come da terapia standard
    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 Decision2022-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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