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    The EU Clinical Trials Register currently displays   44241   clinical trials with a EudraCT protocol, of which   7338   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:2022-000040-30
    Sponsor's Protocol Code Number:202100912
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-08-30
    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 number2022-000040-30
    A.3Full title of the trial
    An open label pilot study of [18AlF]-Resca-IL2 (Interleukin-2 PET tracer) for positron emission tomography imaging in patients treated with immune checkpoint inhibitors.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interleukin-2 PET scans in patients treated with immunotherapy.
    A.3.2Name or abbreviated title of the trial where available
    IL-2 PET imaging in metastatic solid tumours
    A.4.1Sponsor's protocol code number202100912
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIMI Tristan
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointResearchcoordinator Medical Oncolog
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503611847
    B.5.5Fax number+31503614862
    B.5.6E-mailresearchcoordinator@onco.umcg.nl
    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 name[18F]AlF-RESCA-IL2
    D.3.4Pharmaceutical form Solution for injection
    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 INN[18F]AlF-RESCA-IL2
    D.3.9.1CAS number 8000048-25-1
    D.3.9.2Current sponsor code[18F]AlF-RESCA-IL2
    D.3.9.3Other descriptive nameINTERLEUKIN-2
    D.3.9.4EV Substance CodeSUB14225MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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 Yes
    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
    patients with stage IV non-small-cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), CSCC, urothelial cell cancer (UCC), and head and neck squamous cell carcinoma (HNSCC), eligible for ICI therapy (anti-PD-L1, anti-PD-1 and/or anti-CTLA4)
    E.1.1.1Medical condition in easily understood language
    Lung cancer, kidney cancer, skin cancer, bladder cancer and head and heck 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 evaluate safety of repeat doses of [18F]AlF-RESCA-IL2.
    • To evaluate pharmacokinetics (PK) of [18F]AlF-RESCA-IL2 binding in the tumour in patients prior to and during treatment with an immune checkpoint inhibitor.
    • To evaluate whole body distribution of [18F]AlF-RESCA-IL2 in cancer patients.
    E.2.2Secondary objectives of the trial
    • To assess changes in tumour and normal organ uptake after 2 weeks of immune checkpoint inhibitor therapy.
    • To determine whether changes in visual and semi-quantitative [18F]AlF-RESCA-IL2 PET measurements correlate with RECIST v1.1. radiology responses.
    • To correlate tracer uptake with immune cell infiltration in the tumour as assessed by immunohistochemistry.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years at the time of signing informed consent.
    2. Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer, eligible for ICI therapy as part of routine care.
    3. At least 1 lesion that is accessible per investigator’s assessment and eligible for biopsy according to standard clinical care procedures.
    4. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy.
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    6. Life expectancy ≥ 12 weeks.
    7. Signed informed consent.
    8. Willingness and ability to comply with all protocol required procedures.
    9. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate (< 1% per year) when used consistently and correctly)).
    E.4Principal exclusion criteria
    1. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [18F]AlF-RESCA-IL2 injection.
    2. Evidence of an active infection that requires systemic antibiotics within 2 weeks prior to [18F]AlF-RESCA-IL2 injection.
    3. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of [18F]AlF-RESCA-IL2, or that may affect the interpretation of the results or render the patient at high risk from complications.
    4. Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
    5. Sponsor employee/member of the clinical site study team and/or his or her immediate family
    6. Pregnant or lactating females.
    7. Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety evaluation through summaries of adverse events per NCI CTCAE v5.0 criteria, changes in laboratory test results and changes in vital signs after exposure to [18F]-AlF-RESCA-IL2
    • To evaluate the PK of 18F-AlF-RESCA-IL2 binding in the tumor by measuring radioactivity levels in blood by venous blood sampling and tracer uptake in the tumour by dynamic PET imaging. The whole blood and metabolite-corrected plasma radioactivity vs. time curves and the time-radioactivity curve of the tumour are used as input functions for compartment modelling of tracer kinetics. Outcome parameters of pharmacokinetic modelling are the non-displaceable binding potential (BPND) or the total volume of distribution (VT) of the tracer in the tumour, assuming the tracer will also display reversible binding in humans. The “gold standard” parameters BPND or VT will be correlated to the standardized uptake values (SUV) of the tracer in the tumour. In this manner, the use of the semi-quantitative parameter SUV, which can be sensitive to confounding factors, can be validated for use in further studies with this tracer.
    • Evaluation of 18F-AlF-RESCA-IL2 biodistribution in cancer patients on the PET images by measuring standardized uptake values in healthy tissues and organs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    These endpoints will be evaluated throughout the trial
    E.5.2Secondary end point(s)
    • Correlation of 18F-AlF-RESCA-IL2 uptake in tumours, with T cell infiltration in tumour biopsy samples, as determined by IHC.
    • Correlation of 18F-AlF-RESCA-IL2 PET measurements with radiologic response to treatment, according to (i)RECIST v1.1 criteria.
    • Assessment of changes in tumour and normal organ tracer uptake after 2 weeks of treatment, expressed as standardized uptake values.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These endpoints will be evaluated throughout the trial
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    The end of study is defined as the date of the last study procedure.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state14
    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 Decision2022-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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