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    EudraCT Number:2016-003028-22
    Sponsor's Protocol Code Number:RGT100-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-003028-22
    A.3Full title of the trial
    A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects with Advanced or Recurrent Tumors
    Ensayo clínico de fase I/II, multicéntrico, abierto, de administración intratumoral / Intralesional de RGT100 a sujetos con tumores avanzados o recurrentes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first in man study of RGT100 injection into solid tumors
    Primer estudio de inyección de RGT100 en sujetos con tumores sólidos
    A.3.2Name or abbreviated title of the trial where available
    A Phase I/II trial of intralesional administration of RGT100
    Ensayo de fase I/II de administración intralesional de RGT100
    A.4.1Sponsor's protocol code numberRGT100-001
    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 SponsorRigontec GmbH
    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 supportRigontec GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigontec GmbH
    B.5.2Functional name of contact pointDr. Manuela Niewel
    B.5.3 Address:
    B.5.3.1Street AddressAm Klopferspitz 19
    B.5.3.2Town/ cityPlanegg
    B.5.3.3Post code82152
    B.5.4Telephone number+49228763701 11
    B.5.5Fax number+492287637018870
    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 RGT100-PEI
    D.3.4Pharmaceutical form Dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    Intratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRGT100
    D.3.9.2Current sponsor codeRGT100
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Advanced or recurrent tumors
    Tumores avanzados o recurrentes
    E.1.1.1Medical condition in easily understood language
    Advanced or recurrent tumors
    Tumores avanzados o recurrentes
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10024700
    E.1.2Term Liver metastases
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10024717
    E.1.2Term Liver tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluate the safety and tolerability of intratumoral/intralesional injections of RGT100-PEI
    • Determine the recommended Phase 2 dose feasible for intratumoral/intralesional injections of RGT100-PEI
    - Evaluar la seguridad y la tolerabilidad de las inyecciones intratumorales/intralesionales de RGT100-PEI
    - Determinar la dosis recomendada para la fase II viable para las inyecciones intratumorales/intralesionales de RGT100-PEI
    E.2.2Secondary objectives of the trial
    - Explore preliminary anti-tumor activity of RGT100-PEI on injected and un-injected tumor lesions
    The exploratory objectives:
    - Investigate the type of cytokine release in plasma upon treatment
    - Investigate the pharmacokinetics (PK) of RGT100-PEI in subjects with advanced or recurrent tumors
    - Evaluar la actividad antineoplásica preliminar de RGT100-PEI en las lesiones tumorales inyectadas y no inyectadas.
    Los objetivos exploratorios:
    - Investigar el tipo de liberación de citocinas en plasma con el tratamiento
    - Investigar la farmacocinética (FC) de RGT100-PEI en sujetos con tumores recidivantes o avanzados
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is a sub study wihtin the protocol to evaluate the following exploratory objectives, there is no seperate protocol.
    - Explore potential predictive biomarkers of tumor responses upon intratumoral/intralesional RGT100-PEI therapy
    - Evaluate the impact of RGT100-PEI therapy on immune infiltration of injected tumors
    These exploratory objectives will be evaluated in a separate sub-study. Results of these exploratory investigations will not be presented as part of the main Clinical Study Report.
    Hay un subestudio dentro del protocolo para evaluar los siguientes objetivos exploratorios, no hay un protocolo separado:
    - Estudiar los posibles biomarcadores predictivos de las respuestas tumorales al tratamiento intratumoral/intralesional con RGT100-PEI
    - Evaluar el efecto del tratamiento con RGT100-PEI en la infiltración linfocitaria de los tumores inyectados
    Estos objetivos exploratorios se evaluarán en un subestudio independiente. Los resultados de estas evaluaciones exploratorias no se presentarán en el informe del estudio clínico principal.
    E.3Principal inclusion criteria
    1. Male or female aged ≥ 18 years
    2. Histologically or cytologically confirmed diagnosis of advanced or recurrent tumors (including lymphomas) for whom RGT100-PEI is a suitable treatment option and:
    a. For Group A: has cutaneous, subcutaneous, or lymph node injectable tumors
    b. For Group B: has injectable liver tumors or liver metastases
    3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    4. Life expectancy > 3 months as assessed by the Investigator
    5. Adequate organ function:
    a. Bone marrow function: Hemoglobin ≥ 10 g/dL (pre-treatment transfusion allowed); lymphocyte count ≥ 0.5 × 109/L; absolute neutrophil count ≥ 0.5 × 109/L; platelet count ≥ 75 × 109/L
    b. Hepatic function: aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × upper limit of normal (ULN) (3 × ULN in the case of liver metastases); bilirubin ≤ 1.5 × ULN (2 × ULN in case of liver metastases)
    c. Renal function: creatinine < 1.5 × ULN and/or creatinine clearance ≥ 50 mL/min (Cockroft and Gault)
    6. Negative serum pregnancy test within 2 weeks before first dose of study drug if the subject is a woman of childbearing potential. Subjects and subjects’ partners of childbearing potential must agree to use birth control consistently and correctly during the study and for at least 6 months after the last study drug application.
    7. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and 1 separate injectable lesion with diameter ≥ 1 cm but < 7 cm
    8. Ability to provide written informed consent before any study drug-related screening procedures being performed
    1. Hombres y mujeres de 18 años o más.
    2. Diagnóstico de tumores avanzados o recidivantes (linfomas incluidos) confirmado histológica o citológicamente en el caso de sujetos para los que RGT100-PEI sea una opción de tratamiento adecuada y:
    a.Grupo A: tumores cutáneos, subcutáneos o en ganglios linfáticos que puedan tratarse con inyecciones.
    b.Grupo B: tumores o metástasis hepáticas que puedan tratarse con inyecciones.
    3. Estado funcional del Grupo Oncológico Cooperativo de la Costa Este (ECOG) de 0-2.
    4. Esperanza de vida > 3 meses, determinada por el investigador.
    5. Función adecuada de los órganos:
    a.Función de la médula ósea: hemoglobina≥10 g/dl (se admite la transfusión antes del tratamiento) recuento de linfocitos≥0,5 x 109/l; recuento absoluto de neutrófilos≥0,5 x 109/l; plaquetas≥75 x 109/l
    b.Función hepática: aspartato-aminotransferasa (ASAT) y alanina-aminotransferasa (ALAT)≤2 veces el límite superior de la normalidad (LSN) (3 veces el LSN en el caso de metástasis hepáticas); bilirrubina≤1,5 veces el LSN (2 veces el LSN en caso de metástasis hepáticas).
    c.Función renal: creatinina<1,5 veces el LSN y/o aclaramiento de creatinina≥50 ml/min (Cockroft y Gault).
    6. Prueba de embarazo en suero negativa en las dos semanas anteriores a la administración de la primera dosis del fármaco en estudio si el sujeto es una mujer fértil. Los sujetos del ensayo y sus parejas fértiles deberán acceder a utilizar anticonceptivos sistemática y correctamente durante el estudio y por lo menos 6 meses después de la administración de la última dosis del fármaco en estudio.
    7. Al menos una lesión mensurable en función de los Criterios de Evaluación de Respuesta en los Tumores Sólidos (RECIST) 1.1 y una lesión aparte con un diámetro≥1 cm pero 7 cm que admita inyecciones.
    8. Capacidad para otorgar su consentimiento informado por escrito antes de que se realice ningún procedimiento de selección relacionado con el fármaco en estudio.
    E.4Principal exclusion criteria
    1. Any tumor-directed therapy within 4 weeks before study treatment
    2. Treatment with investigational drugs within 4 weeks before study enrolment
    3. Systemic steroids at a dose of > 10 mg of prednisolone, > 2 mg of dexamethasone a day or equivalent, except topical (inhaled, topical, nasal) for the last 28 days and ongoing
    4. Subjects with rapidly progressing disease (as determined by the Investigator)
    5. Ongoing immune-related adverse events (irAEs) and/or AEs ≥ grade 2 not resolved from previous therapies except vitiligo, stable neuropathy grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
    6. Within 4 weeks of major surgery
    7. Prior splenectomy
    8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy
    9. Primary or secondary immune deficiency
    10. Active allergy requiring systemic medication or active infections requiring anti-infectious therapy
    11. Seropositive (except after vaccination) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
    12. Clinically significant cardiac disease including heart failure (New York Heart Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year before study entry
    13. Dementia or altered mental status that would prohibit informed consent
    14. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator
    15. History of stroke, seizures, encephalitis, or multiple sclerosis
    16. Gastric ulcer or inflammatory bowel disease or Crohn’s disease or ulcerative colitis in the last 6 months.
    17. Active drug or alcohol abuse
    18. Pregnant or breast feeding
    1. Someterse a un tratamiento para el tumor en las 4 semanas anteriores al tratamiento del estudio.
    2. Someterse a un tratamiento con fármacos experimentales en las 4 semanas anteriores a la inclusión en el estudio.
    3. Recibir corticoesteroides sistémicos en dosis 10 mg de prednisolone,>2 mg de dexametasona al día o equivalente, salvo por vía tópica (inhalada, tópica o nasal) en los 28 días previos y en el momento de la evaluación.
    4. Sujetos que experimenten una progresión acelerada (determinada por el investigador).
    5.Acontecimientos adversos relacionados con el sistema inmunitario (AAri) en curso y/o AA ≥ grado 2 no resueltos a consecuencia de tratamientos previos, excepto vitiligo, neuropatía estable de grado 2, pérdida de cabello y endocrinopatías estabilizadas con tratamiento de reposición hormonal.
    6. Durante las 4 semanas previas a una cirugía mayor.
    7. Esplenectomía previa.
    8. Antecedentes documentados de trastornos autoinmunitarios generalizados que requieran un tratamiento con inmunodepresores.
    9. Inmunodeficiencia primaria o secundaria.
    10. Alergia generalizada que precise la toma de medicamentos sistémicos o infecciones que precisen de un tratamiento con antiinfecciosos.
    11. Seropositivos para el virus de inmunodeficiencia humana (VIH), el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC) (salvo después de la vacunación).
    12. Cardiopatías significativas desde el punto de vista clínico, incluida la insuficiencia cardíaca (clase III o IV de la New York Heart Association), arritmias preexistentes, angina de pecho o infarto de miocardio no estabilizados el año anterior al inicio del estudio.
    13. Demencia o alteración del estado mental que incapacite para otorgar el consentimiento informado.
    14. Otros trastornos médicos o psiquiátricos o anomalías analíticas severos, agudos o crónicos que pueda aumentar el riesgo que implica el estudio, según considere el investigador.
    15. Antecedentes de accidente cerebrovascular, crisis epilépticas, encefalitis o esclerosis múltiple.
    16. Úlcera gástrica, enfermedad inflamatoria intestinal, enfermedad de Crohn o colitis ulcerosa en los últimos 6 meses.
    17. Alcoholismo o toxicomanía.
    18. Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence and severity of treatment-related adverse events (AEs) and laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE) v.4.03 criteria
    • Occurrence of serious adverse events (SAEs)
    • Occurrence of treatment discontinuation due to treatment-related AEs
    • Incidence and severity of dose limiting toxicities (DLTs)
    - Incidencia y severidad del tratamiento relaccionado con acontecinientos adversos (AEs) y discrepacias de laboratorio, medidos según National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE) v.4.03 criteria
    - Existencia de acontecimientos adversos graves (AAGs)
    - Existencia de discontinuación del tratamiento debido a acontecimientos adversos relacionados con el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after dose escalation and at the end of the trial
    tras aumento escalonado de dosis y al final del ensayo
    E.5.2Secondary end point(s)
    Objective response rate as evaluated radiologically using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
    The exploratory endpoints of the study are:
    • Type of cytokine release in plasma
    • Plasma concentrations of RGT100-PEI and, where feasible, standard PK parameters
    Exploratory end points:
    • Presence of predictive biomarkers of tumor responses
    • Evidence of immune infiltration of injected tumors
    Tasa de respuesta objetiva evaluada radiológicamente usando los Criterios de Evaluación de la respuesta inmune relacionados en tumores sólidos (irRECIST)
    Los criterios exploratorios del estudio son:
    - Tipo de liberación de citoquinas en el plasma
    - Concentraciones plasmáticas de RGT100-PEI y, en su caso, los parámetros farmacocinéticos estándar viables
    Criterios de valoración exploratorios:
    - Presencia de biomarcadores predictivos de respuesta tumoral
    -Evidencia de la infiltración immune
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the trial
    al final del ensayo
    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 Yes
    E.6.11Pharmacogenomic Yes
    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. trial type description
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 the study will be defined as the point when the last subject has completed the last study follow up visit (60 days). Survival follow up after this timepoint will occur but not as part of the study.
    El final del estudio se define como el momento en el que el último sujeto complete la última visita de seguimiento del estudio (60 días). Después de este momento, se llevará a cabo un seguimiento de la supervivencia, pero no en el marco de este estudio.
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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. Non interventional survival follow-up will be performed every 3 months for a period of 24 months after the last subject has completed the trial.
    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 Decision2017-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-18
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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