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    Summary
    EudraCT Number:2020-004494-41
    Sponsor's Protocol Code Number:CLIN2001UCM301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-004494-41
    A.3Full title of the trial
    Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer
    Estudio fundamental, de fase 3, multicéntrico para evaluar la seguridad y la eficacia de la terapia fotodinámica focalizada vascular con TOOKAD (padeliporfina) en el tratamiento del cáncer urotelial de vías urinarias altas de grado bajo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a study that will evaluate the safety and efficacy of TOOKAD® (padeliporfin) Vascular Targeted Photodynamic Therapy (VTP) in the Treatment of Low Grade Upper Tract Urothelial Cancer (UTUC).
    Este estudio evaluará la seguridad y eficacia de TOOKAD (padeliporfina) en el tratamiento del cáncer urotelial de vías urinarias altas de grado bajo
    A.3.2Name or abbreviated title of the trial where available
    ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
    A.4.1Sponsor's protocol code numberCLIN2001UCM301
    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 SponsorSteba Biotech, S.A.
    B.1.3.4CountryLuxembourg
    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 supportSteba biotech, S.A.
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSTEBA biotech S.A.
    B.5.2Functional name of contact pointHead of Global R&D
    B.5.3 Address:
    B.5.3.1Street Address7 place du Théâtre
    B.5.3.2Town/ cityLuxembourg
    B.5.3.3Post codeL-2613
    B.5.3.4CountryLuxembourg
    B.5.4Telephone number0043664203 4173
    B.5.6E-maild.perry@stebabiotech.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 Yes
    D.2.1.1.1Trade name TOOKAD®
    D.2.1.1.2Name of the Marketing Authorisation holderSteba biotech S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for 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 INNPADELIPORFIN
    D.3.9.1CAS number 886845-72-3
    D.3.9.2Current sponsor codeWST11
    D.3.9.3Other descriptive namePalladium Bacteriopheophorbide Monolysotaurine
    D.3.9.4EV Substance CodeSUB31318
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.15
    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 Yes
    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
    Low Grade Upper Tract Urothelial Cancer
    Cáncer urotelial de vías urinarias altas de grado bajo
    E.1.1.1Medical condition in easily understood language
    Urinary tract cancers
    Cancer vías urinarias
    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 LLT
    E.1.2Classification code 10077840
    E.1.2Term Urothelial cancer of renal pelvis
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046375
    E.1.2Term Ureter cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy and durability of effect following TOOKAD (padeliporfin) VTP on low grade UTUC tumors in the calyces, renal pelvis and ureter
    Demostrar la eficacia y la perdurabilidad del efecto de la terapia VTP con TOOKAD (padeliporfina) en los tumores del CU-VUA bien diferenciado en los cálices, la pelvis renal y el uréter.
    E.2.2Secondary objectives of the trial
    -To evaluate TOOKAD (padeliporfin) VTP related safety and tolerability in the treatment of low grade UTUC tumors in the calyces, renal pelvis and ureter
    -To explore a potential link between UTUC cancer genomic markers and treatment related clinical outcomes and disease progression
    - Evaluar la seguridad y la tolerabilidad relacionadas con la terapia VTP con TOOKAD (padeliporfina) en el tratamiento de los tumores del CU-VUA bien diferenciado en los cálices, la pelvis renal y el uréter.
    - Investigar la posible relación entre los marcadores genómicos del CU-VUA y los resultados clínicos relacionados con el tratamiento y la progresión tumoral.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    -To evaluate the pharmacokinetic profile in UTUC patients with moderate hepatic impairment.
    - Evaluar el perfil farmacocinético en los pacientes con CU-VUA que padecen insuficiencia hepática moderada.
    E.3Principal inclusion criteria
    1.Male and female patients 18 years or older
    2.Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
    3.New or recurrent low-grade, non-invasive UTUC disease
    4.Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
    5.Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces, renal pelvis or in the ureter of ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length).
    6.Karnofsky Performance Status ≥ 50%
    7.Adequate organ function defined at baseline as:
    ▪ANC ≥1,000/ μl,
    ▪Platelets ≥75,000/ μl, Hb ≥9 g/dl,
    ▪INR ≤2
    ▪Estimated glomerular filtration rate eGFR ≥30 ml/min using CKD-EPI Method
    ▪Total serum bilirubin <3 mg/dL, AST/ALT ≤5× upper limit of normal
    1. Pacientes de ambos sexos de al menos 18 años.
    2. Capacidad para comprender y otorgar el consentimiento informado por escrito, y disposición a someterse a todas las pruebas y procedimientos relacionados con el estudio.
    3. CU-VUA no infiltrante bien diferenciado nuevo o recidivante.
    4. Enfermedad demostrada por biopsia. Se exigirá la conformidad del evaluador central de anatomía patológica para determinar la idoneidad.
    5. Hasta dos focos de afectación tumoral de bajo grado de diferenciación confirmados mediante biopsia con el tumor de mayor tamaño (tumor de referencia) de entre 5 mm y 15 mm de diámetro (medido mediante endoscopia), ambos localizados en los cálices, la pelvis renal o el uréter del riñón ipsilateral, con ausencia de células tumorales poco diferenciadas en la citología. (La afectación del uréter debe estar en una localización anatómica con una longitud ureteral contigua no superior a 20 mm).
    6. Estado funcional de Karnofsky del ≥50 %.
    7. Función orgánica adecuada definida en el momento basal como sigue:
    ■ CAN ≥1000/μl
    ■ Plaquetas ≥75 000/μl, Hb 9 g/dl
    ■ INR ≤2
    ■ Filtración glomerular estimada (FGe) ≥30 ml/min (con el método CKD-EPI, referencia 13 y apéndice 4)
    ■ Bilirrubina sérica total <3 mg/dl, AST/ALT ≤5 veces el límite superior de la normalidad
    E.4Principal exclusion criteria
    1.Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
    2.Carcinoma in situ (CIS) current or previous in the upper urinary tract
    3.History of invasive T2 or higher urothelial cancer in past 2 years
    4.Participation in another clinical study involving an investigational product within 1 month before study entry
    5.BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
    6.Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment
    7.Prohibited medication that could not be adjusted or discontinued prior to study treatment
    8. Patients with photosensitive skin diseases or porphyria
    9.Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease, severe pulmonary or liver disease or current heavy smoker that, in the opinion of the study investigator, would make the patient a poor candidate for the study
    10.Pregnant or breast-feeding women
    Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry.
    11.Men and women of reproductive potential not willing to observe conventional and effective birth control for the duration of treatment and for 90 days following the last TOOKAD VTP treatment
    1. Presentar en la actualidad un carcinoma urotelial de vejiga (>pT1) con infiltración muscular o poco diferenciado.
    2. Presentar en la actualidad o tener antecedentes de carcinoma in situ (CIS) en las vías urinarias altas.
    3. Haber tenido carcinoma urotelial infiltrante T2 o mayor en los 2 últimos años.
    4. Haber participado en otro estudio clínico de un producto en investigación en el mes previo a la incorporación al estudio.
    5. Haber recibido tratamiento con BCG o quimioterapia local (incluido el tratamiento dirigido al VEGF) en las vías urinarias altas en los 2 meses previos a la inclusión.
    6. Haber recibido quimioterapia sistémica (incluido el tratamiento dirigido al VEGF) en los 2 meses previos a la inclusión.
    7. Estar en tratamiento con medicamentos prohibidos que no pudieron ajustarse o suspenderse antes de recibir el tratamiento del estudio (véanse la lista del apéndice 3 y las indicaciones del apartado 11.4.4).
    8. Presentar dermatosis fotosensible o porfiria.
    9. Presentar cualquier otro trastorno médico o psiquiátrico concomitante, como insuficiencia cardíaca descompensada, angina inestable, arteriopatía coronaria, neumopatía o hepatopatía graves o ser un gran fumador, que, en opinión del investigador del estudio, haría que el paciente no fuese un buen candidato para participar en el estudio.
    10. Estar embarazada o en período de lactancia.
    • Las mujeres con capacidad de procrear (MCCP) deberán dar negativo en la prueba de embarazo en suero realizada antes de incorporarse al estudio.
    11. Los varones y las mujeres con capacidad de procrear que no estén dispuestos a utilizar un método anticonceptivo habitual y eficaz durante el tratamiento del estudio y hasta 90 días después del último tratamiento VTP con TOOKAD.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter on endoscopic evaluation. This outcome will be determined dichotomously as either failure or success in achieving complete response.

    Complete Response will be defined as absence of disease based on:
    •absence of visual tumor on endoscopy
    •no evidence of tumor on biopsy (if feasible)
    •negative urinary cytology by instrumented collection

    Additional information are part of the protocol (section Primary Endpoint/Estimand)
    El criterio de valoración principal de la eficacia es la ausencia de tumores del CU-VUA en todos los cálices, la pelvis renal y el uréter ipsilaterales en la exploración endoscópica. Esta variable se determinará de forma dicotómica como fracaso o éxito en la consecución de una respuesta completa.

    La respuesta completa se definirá como la ausencia de enfermedad según lo siguiente:

    • Ausencia de tumores visibles en la endoscopia.
    • Ausencia de signos tumorales en la biopsia (si es posible).
    • Resultado negativo en la citología urinaria realizada con muestras extraídas mediante instrumental.

    En el protocolo se incluye información adicional (section Primary Endpoint/Estimand) .
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be evaluated at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during the TOOKAD (padeliporfin) VTP induction treatment phase.
    Este criterio se evaluará en el momento de la evaluación principal de la respuesta (EPR) (28 +/–3 días después del último tratamiento) en la fase de tratamiento de inducción con terapia VTP con TOOKAD (padeliporfina).
    E.5.2Secondary end point(s)
    1.The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter
    2.The duration of response at the Treatment Area of the ipsilateral kidney will be defined as absence of disease in the ipsilateral Treatment Area
    3.Overall renal functional outcome
    4.Kidney organ loss or preservation
    5.Pathological evaluation of response performed in kidney tissue of patient that will undergo kidney surgical removal following at least ne TOOKAD VTP treatment
    6.Safety follow up based and recording of adverse events

    Additional information are part of the protocol (section secondary Endpoint/Estimands)
    1. La duración de la respuesta en todo el riñón ipsilateral se definirá como la ausencia de tumores en todos los cálices, la pelvis renal y el uréter ipsilaterales
    2. La duración de la respuesta en la zona de tratamiento del riñón ipsilateral se definirá como la ausencia de enfermedad en la zona de tratamiento ipsilateral
    3. Resultado de la evaluación de la función renal.
    4. La extirpación o conservación del riñón.
    5. Evaluación anatomopatológica de la respuesta en el tejido renal de los pacientes que se sometan a una extirpación quirúrgica del riñón después de al menos un tratamiento VTP con TOOKAD.
    6. Seguimiento de la seguridad y registro de los acontecimientos adversos.

    En el protocolo se incluye información adicional (section secondary Endpoint/Estimands).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Measured at the 3, 6, 9, 12, 18, 24, 36, 48, and 60 months post PRE
    2.Measured at the 3, 6, 9, 12, 18, 24, 36, 48, and 60 months post PRE
    3.Measured at the 6, 12, 18, 24, 36, 48, and 60 months post PRE
    4.Measured at the 3, 6, 9, 12, 18, 24, 36, 48, and 60 months post PRE
    5.Whenever possible for patients that will undergo kidney surgical removal post PRE
    6. Safety at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months post PRE
    Timepoints at 18 ,24 36, 48 and 60 month months post PRE for patients who have a CR in at the end of maintenance treatment phase or 6 and 12 months post PRE if the patient has not participated to Maintenance treatment phase or 6 and 12 months post last VTP for patient discontinued from the treatment phases.
    1. Se analizará a l s 3,6,9,12,18,24,36,48 y 60 meses después de la EPR.
    2. Se analizará a los 3,6,9,12,18,24,36,48 y 60 meses después de la EPR.
    3. Se analizará a los 6,12,18,24,36,48 y 60 meses después de la EPR.
    4. Se analizará a los 3,6,9,12,18,24,36,48 y 60 meses después de la EPR.
    5. Cuando sea posible pacientes que se sometan a una extirpación quirúrgica del riñón después de la EPR.
    6. Seguridad a los 3,6,9,12,18,24,36,48 y 60 meses después de la EPR.
    Puntos temporales a los 18,24,36,48 y 60 meses después de la EPR en los pacientes con RC en el fin de la fase de tto de mtto o a los 6 y 12 meses después de la EPR i los pacientes no han participado en la fase de tto de mtto o a los 6 y 12 meses despues de la ultima VTP por pacientes discontinuados de la fase de tto.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tumour genomic
    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) 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Israel
    United States
    Austria
    France
    Spain
    Germany
    Italy
    United Kingdom
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months7
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 27
    F.4.2.2In the whole clinical trial 100
    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 trial, the patient care will revert to their physicians
    Despues del estudio, el cuidado del paciente volverá a su médico.
    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 Decision2023-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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