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    Summary
    EudraCT Number:2019-002409-23
    Sponsor's Protocol Code Number:CLN-081-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-002409-23
    A.3Full title of the trial
    A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
    Een fase 1/2a-, open-label, multicenter onderzoek ter beoordeling van de veiligheid, verdraagbaarheid, farmacokinetiek, farmacodynamiek en werkzaamheid van CLN-081 bij patiënten met niet-kleincellige longkanker die EGFR exon 20-insertiemutaties bevat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2a Study of CLN-081 in Patients with Lung Cancer
    A.3.2Name or abbreviated title of the trial where available
    CLN-081 in exon 20 mutant NSCLC
    CLN-081 bij NSCLC met mutaties in exon 20
    A.4.1Sponsor's protocol code numberCLN-081-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04036682
    A.5.4Other Identifiers
    Name:IND number: Number:144052
    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 SponsorCullinan Pearl Corp.
    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 supportCullinan Pearl Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCullinan Pearl Corp.
    B.5.2Functional name of contact pointCLN-081-001 Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1 Main Street, Suite 520
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16174104650
    B.5.6E-mailCLN081001trial@cullinanoncology.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 CLN-081
    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 INNCLN-081
    D.3.9.2Current sponsor codeCLN-081
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CLN-081
    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 INNCLN-081
    D.3.9.2Current sponsor codeCLN-081
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    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 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 I - Dose Escalation and Expansion
    • Assess the safety and tolerability of orally administered CLN-081 monotherapy.
    • Define the maximum tolerated dose (MTD) of orally administered CLN-081 monotherapy.

    Phase 2a - Dose Expansion
    • Evaluate the overall response rate (ORR) of orally administered CLN-081 monotherapy.
    • Define the Recommended Phase 2 dose (RP2D) of orally administered CLN-081 monotherapy.
    E.2.2Secondary objectives of the trial
    Phase I Dose Escalation and Expansion
    • To assess the anti-tumor activity of orally administered CLN-081 monotherapy.
    • To characterize select pharmacokinetic (PK) parameters associated with orally administered CLN-081 monotherapy.
    • To assess activity of orally administered CLN-081 monotherapy in patients with known central nervous system (CNS) disease.

    Phase 2a - Dose Expansion
    • Evaluate duration of response (DOR), disease control rate (DCR), progression free survival (PFS), survival rate, and overall survival (OS) of orally administered CLN-081 monotherapy.
    • Confirm the safety and tolerability of orally administered CLN-081 monotherapy.
    • To further characterize select PK parameters associated with orally administered CLN-081 monotherapy.
    • To assess activity of orally administered CLN-081 monotherapy in patients with known CNS disease.
    • To compare the safety, tolerability and efficacy of CLN-081 administered BID with the same total dose administered QD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed recurrent, metastatic NSCLC.
    2. Documented EGFR exon 20 insertion mutation may be demonstrated by:
    a. An FDA-approved device including cobas EGFR Mutation Test v2, therascreen EGFR RGQ PCR Kit, FoundationOne CDx, or MSK-IMPACT, or
    b. A device or test validated and accepted by regulatory health authorities outside the United States for patients enrolled in the trial outside of the United States.
    3. At least one prior treatment with platinum-based chemotherapy. Note: Prior treatment with a PD-1/PD-L1 inhibitor is allowed by not required.
    4. Measurable disease by RECIST 1.1.
    5. Age ≥ 18 years.
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
    7. Ability to take pills by mouth.
    8. Have the following laboratory values:
    a. Serum creatinine < 1.5 × ULN or if higher than normal range, calculated creatinine clearance (CrCl) must be ≥ 50 mL/min/1.73 m2 (by Cockroft-Gault formula); actual body weight must be used for CrCl unless BMI >30 kg/m2 then lean body weight must be used.
    b. Total bilirubin ≤ 1.5 × ULN unless prior history of Gilbert’s syndrome.
    c. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor.
    d. Hemoglobin ≥ 9.0 g/dL.
    e. Platelets ≥ 100 × 10E9 cells/L.
    f. Absolute neutrophil count ≥ 1.5 ×10E9 cells/L.
    9. Ability to understand and the willingness to sign a written informed consent document.
    E.4Principal exclusion criteria
    Accelerated Titration Patients Only
    1. EGFR-TKIs (e.g., gefitinib, erlotinib, afatinib, and osmertinib) within eight days or 5x the terminal phase elimination half-lives, whichever is longer, of the first dose of study drug on C1D1.

    Rolling Six, Phase 1 Expansion, and Phase 2a Expansion Patients Only
    2. Prior treatment with any of the following:
    a. An EGFR-TKI of > 6 months in which the patient derived clinical benefit.
    b. An EGFR exon 20 insertion-targeting drug (e.g., poziotinib, TAK788) for > 2 cycles or discontinuation due to progressive disease.
    Note: Patients that discontinued an EGFR 20 insertion-targeting inhibitor for other reasons (e.g, intolerabilty) and have received ≤ 2 cycles of treatment may not be excluded upon agreement between the Investigator and Sponsor.

    All Patients
    3. Treatment with any of the following:
    a. Systemic anticancer treatment (excluding EGFR-TKIs as described above) within 14 days prior to the first dose of study drug on C1D1.
    b. Limited-field radiotherapy within one week or extended-field thoracic radiotherapy within four weeks of study drug on C1D1.
    c. Major surgery (excluding placement of vascular access) within four weeks of the first dose of study drug on C1D1.
    4. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
    5. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, treated with surgery and/or radiation, and has been stable without requiring escalating corticosteroids or anti-convulsant medications for at least four weeks prior to the first dose of study drug on C1D1.
    6. Prior therapy with CLN-081.
    7. Known hypersensitivity to CLN-081 or any drugs similar in structure or class.
    8. Cardiac conditions as follows: Patient has a history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
    9. Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs).
    10. Patient is unable to take drugs orally due to disorders or diseases that may affect gastrointestinal function, such as inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis) or malabsorption syndrome, or procedures that may affect gastrointestinal function, such as gastrectomy, enterectomy, or colectomy.
    11. Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.
    12. Pregnant or lactating women; women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at within seven day prior to receiving study drug on C1D1. WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for six months following the last dose of study treatment.
    13. History of another primary malignancy within 2 years prior to starting study drug on C1D1, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
    14. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including hepatitis B, hepatitis C, HIV, and active clinical tuberculosis), or renal transplant; ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements.
    15. Active bleeding disorders.
    16. Is, in the Investigator’s opinion, unable or unwilling to comply with the trial procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I - Dose Escalation and Expansion
    • The rate and severity of treatment emergent AEs, DLTs, Incidence of safety laboratory assessment abnormalities.
    • Incidence of abnormalities in vital signs or other clinical safety assessments

    Phase 2a - Dose Expansion
    • The rate and severity of treatment emergent AEs, DLTs, Incidence of safety laboratory assessment abnormalities
    • Incidence of abnormalities in vital signs or other clinical safety assessments.
    • Tumor response rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    Phase I - Dose Escalation and Expansion
    • Tumor response rate
    • Tumor response including DOR, DCR, PFS, and OS
    • CLN-081 pharmacokinetics

    Phase 2a - Dose Expansion
    • Tumor response including DOR, DCR, PFS, and OS
    • CLN-081 pharmacokinetics
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1/2a study including first administration to humans
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA4
    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
    Canada
    China
    France
    Hong Kong
    Japan
    Netherlands
    Singapore
    Taiwan
    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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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) No
    F.1.3.1Number of subjects for this age range: 65
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 132
    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 Decision2019-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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