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    Summary
    EudraCT Number:2018-002625-38
    Sponsor's Protocol Code Number:ADCT-402-103
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-002625-38
    A.3Full title of the trial
    A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study to assess how safe and how effective is Loncastuximab Tesirine together with Ibrutinib in patients with Advanced Diffuse Large B Cell Lymphoma or Mantle Cell Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    LOTIS-3
    A.4.1Sponsor's protocol code numberADCT-402-103
    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 SponsorADC Therapeutics SA
    B.1.3.4CountrySwitzerland
    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 supportADC Therapeutics SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationADC Therapeutics SA
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressRoute de la Corniche, 3B
    B.5.3.2Town/ cityEpalinges
    B.5.3.3Post code1066
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinicaltrials@adctherapeutics.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1115
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/21/2481
    D.3 Description of the IMP
    D.3.1Product nameLoncastuximab Tesirine
    D.3.2Product code ADCT-402
    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 INNLoncastuximab Tesirine
    D.3.9.2Current sponsor codeADCT-402
    D.3.9.3Other descriptive nameADCT-402
    D.3.9.4EV Substance CodeSUB181458
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL)
    E.1.1.1Medical condition in easily understood language
    Diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1:To characterize the safety and tolerability of loncastuximab tesirine in combination with ibrutinib, and to identify the Maximum tolerated dose (MTD) /recommended dose and schedule for future studies
    Phase 2: To evaluate the efficacy of loncastuximab tesirine given at every cycle in combination with ibrutinib in patients with relapsed or refractory DLBCL
    E.2.2Secondary objectives of the trial
    Phase 1
    •To evaluate the antitumor effect of the combination of loncastuximab tesirine with ibrutinib
    •To characterize the pharmacokinetic (PK) profile of loncastuximab tesirine when given in combination with ibrutinib
    •To evaluate the immunogenicity of loncastuximab tesirine when given in combination with ibrutinib
    Phase 2
    •To further evaluate the safety and efficacy of loncastuximab tesirinein combination with ibrutinib in non-GCB DLBCL, GCB DLBCL, all DLBCL and MCL patients
    •To further evaluate the PK profile and immunogenicity of loncastuximab tesirine when given in combination with ibrutinib
    •To evaluate the impact of the combination on patient-reported outcomes (PROs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patient aged 18 years or older
    2.Pathologic diagnosis of DLBCL or MCL
    3.Patients with DLBCL must have relapsed or refractory disease and have failed or been intolerant to available standard therapy (including stem cell transplant if patient was eligible)
    4.Patients with MCL must have relapsed or refractory disease and have received at least one prior line of therapy
    5.Patients who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy
    6.Measurable disease as defined by the 2014 Lugano Classification
    7.Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available)
    Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
    8.ECOG performance status 0 to 2
    9.Screening laboratory values within the following parameters:
    a.Absolute neutrophil count (ANC) ≥1.0 × 10^3/µL (off growth factors at least 72 hours)
    b.Platelet count ≥75 × 10^3/µL without transfusion in the past 7 days
    c.Hemoglobin ≥8 g/dL (4.96 mmol/L), transfusion allowed
    d.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 × the upper limit of normal (ULN)
    e.Total bilirubin ≤1.5 × ULN (patients with known Gilbert’s syndrome may have a total bilirubin up to ≤3 × ULN)
    f.Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft and Gault equation
    Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility.
    10.Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drugs on C1D1 (cycle 1 day 1) for women of childbearing potential
    11.Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months after the last dose of study therapy loncastuximab teserine or 1 month after last dose of ibrutinib, whichever comes last. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the patient receives his last dose of study therapy loncastuximab teserine or 3 months after last dose of ibrutinib, whichever comes last.
    E.4Principal exclusion criteria
    1.Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody
    2.Known history of hypersensitivity to ibrutinib
    3.Previous therapy with ibrutinib or other BTK inhibitors
    4.Previous therapy with loncastuximab tesirine
    5.Requires treatment or prophylaxis with a moderate or strong cytochrome P450 (CYP) 3A inhibitor
    6.Allogenic or autologous transplant within 60 days prior to start of study drugs (C1D1)
    7.Active graft-versus-host disease
    8.Post-transplantation lymphoproliferative disorder
    9.Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
    10.Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV).
    11.History of Stevens-Johnson syndrome or toxic epidermal necrolysis
    12.Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease
    13.Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
    14.Breastfeeding or pregnant
    15.Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes mellitus, or severe chronic pulmonary disease or tuberculosis infection (tuberculosis screening based on local standards)
    16.Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drugs (C1D1), except shorter if approved by the Sponsor
    17.Use of any other experimental medication within 14 days prior to start of study drugs (C1D1)
    18.Planned live vaccine administration after starting study drugs (C1D1)
    19.Any condition that could interfere with the absorption or metabolism of ibrutinib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
    20.Inherited or acquired bleeding disorders
    21.Ongoing anticoagulation treatment, except for low dose heparinisation or equivalent
    22.Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening
    23.Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block)
    24.Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor’s medical monitor and Investigator agree, and document should not be exclusionary
    25.Any other significant medical illness, abnormality, or condition that would, in the Investigator’s judgment, make the patient inappropriate for study participation or put the patient at risk
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    •Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
    •Incidence of dose limiting toxicities (DLTs) (dose escalation only)
    •Frequency of dose interruptions and dose reductions
    •Changes from baseline of safety laboratory values, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and 12-lead electrocardiograms (ECGs)
    Phase 2:
    •CRR according to the 2014 Lugano classification (Cheson et al., 2014) as determined by Independent Review Committee (IRC) in all DLBCL patients given loncastuximab teserine at every cycle in combination with ibrutinib; CRR defined as the proportion of patients with a best overall response (BOR) of complete response (CR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    there are different timepoints for the evaluation of the primary endpoints
    E.5.2Secondary end point(s)
    Phase 1
    •Overall response rate (ORR) according to the 2014 Lugano classification as determined by investigator. Overall response rate defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR)

    Phase 1 and Phase 2:
    •Duration of response (DOR) defined as the time from the documentation of first tumor response to disease progression or death in the non-GCB DLBCL, GCB DLBCL, all DLBCL and MCL patients
    •Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death
    in the non GCB DLBCL, GCB DLBCL, all DLBCL, and MCL patients
    •Progression-free survival (PFS) defined as the time between start of treatment and the first documentation of progression, or death
    in the non GCB DLBCL, GCB DLBCL, all DLBCL, and MCL patients
    •Overall survival (OS) defined as the time between the start of treatment and death from any cause in the non GCB DLBCL, GCB DLBCL, all DLBCL, and MCL patients
    •Concentrations and PK parameters of loncastuximab tesirine (total antibody, pyrrolobenzodiazepine (PBD)-conjugated antibody, and unconjugated cytotoxin SG3199) in the non GCB DLBCL, GCB DLBCL, all DLBCL, and MCL patients
    •Anti-drug antibody (ADA) titers and, if applicable, neutralizing activity to loncastuximab tesirine in the non GCB DLBCL, all DLBCL, and MCL patients
    Phase 2:
    •ORR according to the 2014 Lugano classification in the non GCB DLBCL, GCB DLBCL, all DLBCL, and MCL patients. ORR as determined by Investigator and/or IRC.
    •CRR according to the 2014 Lugano classification (Cheson et al., 2014) as determined by Investigator and/or IRC in non-GCB DLBCL, all GCB DLBCL, and MCL patients.
    •CRR according to the 2014 Lugano classification (Cheson et al., 2014) as determined by Investigator and / or in all DLBCL patients in the cohort where loncastuximab tesirine is given intermittently in combination with ibrutinib.
    •CRR according to the 2014 Lugano classification (Cheson et al., 2014) as determined by Investigator in all DLBCL patients in the cohort where loncastuximab tesirine is given at every cycle in combination with ibrutinib.
    •Frequency and severity of AEs and SAEs, in the non GCB DLBCL, GCB DLBCL, all DLBCL, and MCL patients
    •Changes from baseline of safety laboratory values, vital signs, ECOG performance status, and 12-lead ECGs in the non GCB DLBCL, GCB DLBCL, all DLBCL and MCL patients
    •Change from baseline in symptoms, functions and overall health status as measured by The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30, LymS of FACT-Lym, and EQ-5D-5L in the non GCB DLBCL, GCB DLBCL, all DLBCL and MCL patients
    • Relation between exposure (loncastuximab tesirine dose, PK metrics) and selected safety, pharmacodynamic (PD)-biomarker, and efficacy endpoints
    • Relation between tumor and/or blood biomarkers and selected safety and efficacy endpoints
    •Comparison of COO readings from investigator sites and central lab(s)
    •Correlations between COO determined by central testing and treatment efficacy assessed by IRC
    E.5.2.1Timepoint(s) of evaluation of this end point
    there are different timepoints for the evaluation of secondary endpoints
    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 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 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 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 EEA14
    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
    United States
    France
    Italy
    Belgium
    E.8.7Trial has a data monitoring committee No
    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
    last visit or last scheduled procedure for the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 166
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 179
    F.4.2.2In the whole clinical trial 238
    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)
    after the patient has ended participation on the study, standard of care treatment by their physician is expected
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-18
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