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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-002259-39
    Sponsor's Protocol Code Number:TL-895-202
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-08-26
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-002259-39
    A.3Full title of the trial
    A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 with Standard Available Treatment versus Standard Available Treatment for the Treatment of COVID-19 in Patients with Cancer
    A szokásos rendelkezésre álló kezeléssel együtt alkalmazott TL-895 szokásos rendelkezésre álló kezeléssel szembeni 1/2. fázisú, kettős vak, randomizált, placebo-kontrollos vizsgálata a COVID-19 kezelésében rákos betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This global, multicenter, Phase 1/2, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of adding TL-895 treatment to standard available therapy (SAT) in subjects with cancer hospitalized for COVID-19.
    Ez a globális, multicentrikus, 1/2 fázisú, randomizált, kettős vak, placebo kontrollált vizsgálat a szokásos rendelkezésre álló kezelés (SAT) mellé alkalmazott TL-895 hatásosságát és biztonságosságát fogja vizsgálni COVID-19 miatt hospitalizált rákos betegeknél
    A.4.1Sponsor's protocol code numberTL-895-202
    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 SponsorTelios Pharma, 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 supportTelios Pharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTelios Pharma, Inc.
    B.5.2Functional name of contact pointAssociate Director, Regulatory
    B.5.3 Address:
    B.5.3.1Street Address275 Shoreline Drive, Suite 325
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 94065
    B.5.3.4CountryUnited States
    B.5.4Telephone number 312-208-7486
    B.5.6E-mailjbockhorn@teliospharma.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 nameTL-895
    D.3.2Product code TL-895
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNTL-895
    D.3.9.1CAS number 1415823-49-2
    D.3.9.2Current sponsor codeTL-895
    D.3.9.3Other descriptive nameM7583
    D.3.9.4EV Substance CodeSUB180031
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients with cancer
    E.1.1.1Medical condition in easily understood language
    COVID-19 in patients with cancer
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1: To evaluate the safety and tolerability of TL-895 in COVID-19 infected subjects and determine the recommended Phase 2 dose (RP2D)
    Part 2: To determine whether TL-895 plus standard available therapy (SAT) (Arm 1) can diminish the need for artificial ventilation or death as compared to placebo plus SAT (Arm 2) from Day 1 through Day 29 of study treatment
    E.2.2Secondary objectives of the trial
    Part 1:
    -To determine whether TL-895 can diminish the need for artificial ventilation or death
    -To determine whether TL-895 decreases respiratory failure events that require invasive ventilation or death
    -To determine the time to hospital discharge
    -To examine the 1- and 3-months overall survival
    -To determine the proportion of subjects with viral clearance at time of hospital discharge and post discharge
    -To determine toxicity observed in subjects treated with TL-895
    -To characterize the pharmacokinetic profile of TL-895

    Part 2:
    -To determine whether TL-895 plus SAT (Arm 1) can diminish the need for artificial ventilation or death as compared to placebo plus SAT (Arm 2) during the study
    -To determine whether Arm 1 decreases respiratory failure events that require invasive ventilation or death as compared to Arm 2 during the study.
    -To determine the time to hospital discharge for subjects treated with Arm 1 versus Arm 2
    see Protocol for full list of Secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults ≥18 years of age
    2. Known diagnosis of active cancer that is not considered cured or disease free.
    3. Confirmed COVID-19 infection as per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [e.g., respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of Cycle 1 Day 1) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
    4. Adequate hematological function independent of growth factor support for at least 7 days with the exception of pegylated G-CSF and darbepoetin which require at least 14 days, defined as
    a. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L for subjects with solid malignancies. ANC ≥ 0.75 × 109/L for subjects with hematologic malignancies
    b. Platelet count ≥ 75 × 109/L for subjects with solid malignancies. Platelet count ≥ 50 × 109/L for subjects with hematologic malignancies
    5. Adequate hepatic function defined by:
    a. Total bilirubin within normal limits, if total bilirubin is >upper limit of normal (ULN), then subjects are eligible if the direct bilirubin ≤2.0 × ULN
    b. Aspartate aminotransferase (AST) ≤ 2.5 × ULN, and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
    6. Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according Cockcroft Gault
    7. Ability to swallow and absorb oral medications
    8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Subjects with a life expectancy of less than 6 months
    2. No remaining available therapies for advanced or metastatic malignancies
    3. Subjects with an advanced healthcare directive that includes a do not intubate (DNI) or do not resuscitate (DNR) orders.
    5. Subjects who require chemotherapy due to active oncologic disease that cannot be suspended while receiving study treatment.
    6. Subjects with new onset malignancy who require urgent systemic therapy because of active oncologic disease
    7. Subjects who received systemic chemotherapy resulting in immunosuppression within 14 days of Cycle 1 Day 1.
    8. Active treatment with immunomodulator medications including immune checkpoint inhibitors (PD-1, PD-L1, CTLA4 blockers) that could not be suspended for the duration of the study.
    9. Subjects who received prior anti-cytokine therapy (anti-IL-6) within 5 half-lives of the drug from Cycle 1 Day 1.
    10. Participation in another clinical study with therapeutic intent for COVID-19. The only exception is that patients participating in clinical trials receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir will be allowed
    11. Patients on warfarin at study entry
    12. Patients on combined anti-platelet and therapeutic anti-coagulation therapy (LMWH or DOAC).
    13. Myocardial infarct within 6 months, unstable angina, uncontrolled cardiac arrhythmia, or New York Heart Association (NYHA) class 3/4 heart failure
    14. Requirement for artificial ventilation (HFNC, NiPPV, ECMO, or intubation and MV) at screening
    15. Known bleeding disorders (e.g., Von Willebrand’s disease, platelet storage pool disorders, or hemophilia)
    16. Stroke or intracranial hemorrhage within 6 months of Cycle 1 Day 1
    17. Women who are pregnant or breastfeeding
    18. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study.
    19. Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV)
    20. Subjects with known history of human immunodeficiency virus (HIV)
    21. Grade 2 or higher QTc prolongation (> 480 milliseconds per National Cancer Institute Common Terminology of Adverse Events [v 5.0])
    22. Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.)
    23. Patients receiving radiation therapy to the lung or mediastinum for treatment of COVID-19
    24. Untreated or actively progressing known CNS lesions (carcinomatous meningitis). Patients with a history of CNS lesions are eligible, provided that all of the following criteria are met:
    – All known CNS lesions have been treated with radiotherapy or surgery.
    – Any radiotherapy or surgery must be completed ≥ 4 weeks prior to initiation of study treatment.
    – No history of intracranial hemorrhage from CNS lesions
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: DLTs will be used to establish the RP2D.
    Part 2: The proportion of subjects per arm requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death from Day 1 through Day 29 of study treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    E.5.2Secondary end point(s)
    Part 1:
    - The proportion of subjects requiring artificial ventilation (intubation and MV, ECMO, HFNC, NiPPV) or death
    - The proportion of subjects requiring intubation and MV, ECMO or death.
    - Duration from first dose to hospital discharge.
    - Time from first dose to landmark follow-up or death from any causes.
    - SARS-CoV-2 Nasopharyngeal Swab test by polymerase chain reaction (PCR)
    - Analyses of the safety endpoints will include the following measurements or assessments: physical examinations, laboratory tests, adverse events (AEs), serious AEs (SAEs), electrocardiograms (ECGs), vital signs.
    - TL-895 PK parameters, including but not limited to:
    • Predose concentration (C0h)
    • Concentration at 2 hours post-dose (C2h)
    • Maximum observed concentration (Cmax)
    • Time of maximum concentration (Tmax)
    • Area under the plasma concentration-time curve (AUC)
    Part2:
    -The proportion of subjects per arm requiring artificial ventilation (intubation and MV, ECMO, HFNC, NiPPV) or death
    -The proportion of subjects per arm requiring intubation and MV, ECMO or death
    -Duration from randomization to hospital discharge per arm.
    -Time from randomization to landmark follow-up or death from any causes.
    -SARS-CoV-2 Nasopharyngeal Swab test by polymerase chain reaction (PCR)
    -Analyses of the safety endpoints will include the following measurements or assessments: physical examinations, laboratory tests, adverse events (AEs), serious AEs (SAEs), electrocardiograms (ECGs), vital signs.
    -TL-895 PK parameters, including but not limited to:
    • Predose concentration (C0h)
    • Concentration at 2 hours post-dose (C2h)
    • Maximum observed concentration (Cmax)
    • Time of maximum concentration (Tmax)
    • Area under the plasma concentration-time curve (AUC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1 and 8, Hospital Discharge, 1 and 3 months Follow-up
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1 safety lead-in
    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 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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard available therapy (SAT)
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Argentina
    Brazil
    France
    Germany
    Hungary
    Italy
    Peru
    Philippines
    Russian Federation
    Spain
    Ukraine
    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 years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 67
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 79
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 146
    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)
    none
    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 Decision2020-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-15
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