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    Summary
    EudraCT Number:2019-001459-38
    Sponsor's Protocol Code Number:KTP-004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-12-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-001459-38
    A.3Full title of the trial
    A Phase II study of selective HDAC6 inhibition with KA2507 in advanced biliary tract cancer previously treated with standard of care chemotherapy (ABC-11)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Finding the tolerable recommended dose of KA2507 and how effective it is at treating patient with advance biliary tract cancer who have previously been treated with standard of care chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    ABC-11
    A.4.1Sponsor's protocol code numberKTP-004
    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 SponsorKarus Therapeutics Limited
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCancer Research UK & Cancer Trials Centre
    B.5.2Functional name of contact pointMichelle Hung
    B.5.3 Address:
    B.5.3.1Street Address90 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number02076799887
    B.5.6E-mailctc.abc11@ucl.ac.uk
    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 nameKA2507
    D.3.2Product code N/A
    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 INNKA2507
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeKA2507
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Biliary Tract Cancer
    E.1.1.1Medical condition in easily understood language
    Advanced Biliary Tract cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 the preliminary efficacy of KA2507 in patients with advanced biliary tract cancer previously treated with standard of care chemotherapy
    E.2.2Secondary objectives of the trial
    To evaluate tumour response to KA2507 (response rates and duration of response)

    To evaluate overall survival

    To characterise the safety and tolerability profile of KA2507.

    To characterise the pharmacokinetic profile of KA2507 in a subset of patients

    To determine the pharmacodynamic response to KA2507 in a subset of patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. Signed informed consent
    3. Histological or cytological diagnosis of advanced (i.e. metastatic disease, or irresectable locally advanced, or recurrent) BTC (to include intra or extra hepatic and gallbladder; ampullary cancer will not be included)
    4. Patient must have disease amenable to biopsy and be willing to undergo this procedure at baseline and on-treatment
    5. Clear evidence of disease progression following standard of care first line therapy as defined by RECIST Version 1.1, OR clear evidence of disease progression based on the emergence of non-measurable disease (e.g. new cytologically confirmed ascites, pleural or pericardial effusion). Patients intolerant of first-line standard of care chemotherapy will also be eligible provided there is evidence of disease progression
    6. At least one target lesion measurable as defined by RECIST Version 1.1 using computed tomography (CT) or magnetic resonance imaging (MRI)
    7. Eastern Co-operative Ongology Group (ECOG) performance status Grade 0 or
    8. Adequate biliary drainage, with no evidence of ongoing infection
    9. Estimated life expectancy >3 months
    E.4Principal exclusion criteria
    1. Unresolved or unstable adverse effects of prior chemotherapy or radiotherapy, i.e. ≥Grade 2 according to CTCAE Version 5.0 except alopecia and infertility
    2. Clinical evidence of cerebral metastases
    3. History of previous malignancy that could interfere with response evaluation
    4. Concurrent treatment with other investigational drugs within 4 weeks or 6 half-lives of initiating treatment
    5. Inadequate renal, liver, or haematological function defined as any of:
    • Significant renal impairment, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
    • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 x upper limit of normal (ULN)
    - Neutropenia (absolute neutrophil count [ANC]<1.5 x 109/L)
    - Platelets <100 x 109/L
    - Haemoglobin ≤9 g/dL). NB the use of transfusion to achieve desired haemoglobin is acceptable
    - Total bilirubin ≥1.5 x ULN (except for patients with known Gilbert’s syndrome)
    6. Known haemoglobinopathy due to haemoglobin S or haemoglobin C disease, α or β thalassemia, or glucose-6-phosphate dehydrogenase deficiency
    7. Concomitant use of dapsone
    8. Untreated severe thyroid dysfunction (hypo- or hyper-thyroidism)
    9. Significant heart disease defined as any of the following:
    - New York Heart Association Grade 3 or 4 symptomatic heart failure
    - Symptomatic cardiomyopathy
    - Unstable angina or acute myocardial infarction within 3 months
    - Cardiac ventricular arrhythmia within 3 months that is not controlled by drug therapy and/or by cardiac ablation
    - QT interval corrected using Fridericia’s formula (QTcF) >470 ms on screening ECG or history of Torsades de pointes
    10. Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient’s participation in the study
    11. Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C virus (HCV). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid
    12. Active infection requiring antibiotics within two weeks prior to treatment
    13. Males who are unable or unwilling to use barrier contraception during treatment and for 3 months after
    14. Women who are pregnant, breast-feeding or either unable or unwilling to use effective means of contraception during treatment
    15. Patients who are unable to swallow capsules and/or have a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis
    16. Any other condition that would, in the Investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
    E.5 End points
    E.5.1Primary end point(s)
    To assess the preliminary efficacy of KA2507 in patients with advanced biliary tract cancer previously treated with standard of care chemotherapy. This will will be measured by Progression free survival (PFS) at 4 months (objective disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Reports will be provided by the TMG to the Independent Data Monitoring Committee (IDMC), who will review accrual, compliance, safety and efficacy. The first review will be triggered after the first six patients have completed 4 months of follow-up. The second review by the IDMC will be triggered after 17 patients are treated once 4-month PFS data are available for these 17 patients, and at least once each year thereafter. If less than 3 patients out of the first 17 are alive and progression-free at 4 months the IDMC might recommend the stop the trial.
    E.5.2Secondary end point(s)

    • To assess the effect of KA2507 on overall response rate, duration of objective response, duration of disease control and time to progression per RECIST Version 1.1.
    • Overall survival - Time to death after study treatment.
    • Incidence of adverse events (CTCAE Version 5.0), clinical laboratory abnormalities and 12-lead ECG abnormalities to characterise the safety and tolerability profile of KA2507 at the recommended phase II dose.
    • Worst grade of adverse events (CTCAE Version 5.0)to characterise the safety and tolerability profile of KA2507 at the recommended phase II dose.
    • Frequency of dose modifications, discontinuations, dose interruptions to characterise the safety and tolerability profile of KA2507 at the recommended phase II dose.
    • KA2507 plasma pharmacokinetic parameters including Tmax, Cmax, T½, AUC0-τ, AUClast and AUC0-∞ to characterise the pharmacokinetic profile of KA2507 at the RP2D for up to 6 patient.
    • To determine the pharmacodynamic response to KA2507 for up to 6 patients.
    E.5.2.1Timepoint(s) of evaluation of this end point

    The best ORR consists of the best among all objective responses assessed.
    OS is defined as the time from registration to death from any cause. PFS is defined as time from registration to time of progression or time of death from any cause.
    Duration of objective response is defined as the time from initial complete or partial response to disease progression or death on study from any cause whichever occurs first.
    Duration of disease control is defined as the time from start of treatment to disease progression
    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
    Phase I dose escalation
    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 No
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of trial will be Last Subject Last Visit.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    If a patient discontinues trial treatment early, they will remain on trial for follow up purposes unless they explicitly withdraw consent. Subsequent treatment will be at the discretion of the treating clinician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-01
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