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    Summary
    EudraCT Number:2019-000907-34
    Sponsor's Protocol Code Number:H-200-001
    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:2021-07-08
    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 number2019-000907-34
    A.3Full title of the trial
    A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers
    Estudio en fase I/II de los vectores TheraT® que expresan antígenos específicos del virus papiloma humano 16 positivo (VPH 16+) en pacientes con cánceres VPH 16+ confirmados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test the regimen of two cancer treatment vaccines in patients with human papillomavirus 16 confirmed cancers.
    Un ensayo clínico para comprobar el régimen de dos vacunas para el tratamiento del cáncer en pacientes con cánceres de virus papiloma humano 16 confirmados
    A.4.1Sponsor's protocol code numberH-200-001
    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 SponsorHookipa Biotech GmbH
    B.1.3.4CountryAustria
    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 supportHookipa Biotech
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHookipa Biotech
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressHelmut-Qualtinger-Gasse 2
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1030
    B.5.3.4CountryAustria
    B.5.4Telephone number+431 890 63 60 301
    B.5.6E-mailoffice@hookipapharma.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 nameHB -201
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 2632271-13-5
    D.3.9.2Current sponsor codeHB-201
    D.3.9.3Other descriptive nameLymphocytic choriomeningitis vector expressing Human papillomavirus type 16 E6/E7 fusion protein
    D.3.9.4EV Substance CodeSUB216934
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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.3.1Product nameHB-202
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNNot available
    D.3.9.2Current sponsor codeHB-202
    D.3.9.3Other descriptive namePichinde virus vector expressing Human papillomavirus type 16 E6/E7 fusion protein
    D.3.9.4EV Substance CodeSUB217985
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5700000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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: 3
    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 KEYTRUDA 25 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp &Dohme Limited
    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 Concentrate for solution for infusion
    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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Yes
    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: 4
    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 KEYTRUDA 50 mg Powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp &Dohme Limited
    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 concentrate for solution for infusion
    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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    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 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 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 Yes
    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
    E.1.1.1Medical condition in easily understood language
    Human papilloma virus (HPV 16) associated cancer
    Cáncer asociado a virus papiloma humano (VPH 16)
    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 10081287
    E.1.2Term HPV positive oropharyngeal squamous cell carcinoma
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10041823
    E.1.2Term Squamous cell carcinoma
    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 10063569
    E.1.2Term Metastatic squamous cell carcinoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10046885
    E.1.2Term Vaginal cancer
    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 LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061424
    E.1.2Term Anal cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10034299
    E.1.2Term Penile cancer
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047777
    E.1.2Term Vulvar cancer
    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
    1.To determine the RP2D in terms of safety and tolerability for:
    •IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC
    •IT admin of HB-201 in patients with HPV 16+ confirmed cancers
    •IV admin of HB-202 in patients with HPV 16+ confirmed HNSCC
    •IV admin of HB-202 in patients with HPV 16+ confirmed cancers
    Phase II Dose Expansion
    1. To assess the preliminary antitumor activity of:
    •IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC
    •IT admin of HB-201 followed by IV administration of HB-201 in patients with HPV 16+ confirmed cancers
    •IV administration of HB 201 in combination with pembrolizumab in patients with HPV 16+ confirmed HNSCC
    •Sequential alternating IV admin of HB-201 & HB-202 in patients with HPV 16+ confirmed HNSCC
    •IT admin of HB-201 followed by sequential alternating IV admin of HB 201 & HB 202 in patients with HPV 16+ confirmed cancers
    Please refer to Protocol section for full list in Protocol section 2.
    Fase I de aumento de la dosis
    1. Determinar la DRF2 en términos de seguridad y tolerabilidad para:
    •Administración i.v. de HB-201 en pacientes con CCECC VPH 16+ confirmado
    •Administración IT de HB-201 en pacientes con cánceres confirmados VPH 16+
    •Administración i.v. de HB-202 en pacientes con CCECC VPH 16+ confirmado
    •Administración i.v. de HB-202 en pacientes con cánceres confirmados VPH 16+
    Fase II de expansión de la dosis
    1. Valorar la actividad antineoplásica preliminar de:
    •Administración i.v. de HB-201 en pacientes con CCECC VPH 16+ confirmado
    •Administración IT de HB-201 seguida de administración i.v. de HB-201 en pacientes con cánceres confirmados VPH 16+
    •Administración i.v. de HB-201 en combinación con pembrolizumab en pacientes con CCECC VPH 16+ confirmado
    •Administración i.v. secuencial de HB‐201 y HB-202 alternados en pacientes con CCECC VPH 16+ confirmado
    Por favor consulte la sección 2 del Protocolo para obtener la lista completa
    E.2.2Secondary objectives of the trial
    Phase I Dose Escalation
    1. To assess the safety and tolerability of:
    •IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC
    •IT admin of HB-201 followed by IV administration of HB 201 in patients with HPV 16+ confirmed cancers
    •Sequential alternating IV administration of HB 201 & HB 202 in patients with HPV 16+ confirmed HNSCC
    •IT admin of HB-201 followed by sequential alternating IV administration of HB 201 & HB 202 in patients with HPV 16+ confirmed cancers
    •HB-201 in combination with pembrolizumab in patients with HPV 16+ confirmed cancers
    •HB-201 & HB-202 alternating two-vector therapy in combination with pembrolizumab in patients with HPV 16+ confirmed cancers.
    2. To assess the preliminary antitumor activity of:
    •IV admin of HB-201 as a continuous in patients with HPV 16+ confirmed HNSCC
    •IV administration of HB 201 as a 3-dose treatment in patients with HPV 16+ confirmed HNSCC
    Phase II Dose Expansion
    Please refer to Protocol section for full list in Protocol section 2.
    Fase I de aumento de la dosis
    1. Evaluar la seguridad y la tolerabilidad de:
    •Administración i.v. de HB-201 en pacientes con CCECC VPH 16+ confirmado
    •Administración IT de HB-201 seguida de administración i.v. de HB-201 en pacientes con cánceres confirmados VPH 16+
    •Administración i.v. secuencial de HB‐201 y HB-202 alternados en pacientes con CCECC VPH 16+ confirmado
    •Administración IT de HB-201 seguida de administración i.v. secuencial de HB‐201 y HB-202 alternados en pacientes con cánceres VPH 16+ confirmados
    •HB-201 en combinación con pembrolizumab en pacientes con cánceres VPH 16+ confirmados
    •Tratamiento de dos vectores con HB-201 y HB-202 alternados en combinación con pembrolizumab en pacientes con cánceres VPH 16+ confirmados
    2. Valorar la actividad antineoplásica preliminar de:
    •Administración i.v. de HB-201 como tratamiento continuo en pacientes con CCECC VPH 16+ confirmado
    Por favor consulte la sección 2 del Protocolo para obtener la lista completa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Patients:
    -18 years of age or older
    -≥ 1 measurable lesion by imaging for tumor response following RECIST and iRECIST
    -ECOG performance status of 0 to 1.
    -Prior curative radiation therapy must have been completed ≥ 4 weeks prior to study treatment administration. Prior focal palliative
    radiotherapy must have been completed ≥ 2 weeks prior to study treatment administration.
    -Screening laboratory values must meet protocol-specified criteria Treatment Group 1, Group 3, Group 4, Group 5 Group A, or Group D:
    -Documentation of confirmed HPV 16+ HNSCC via genotype testing
    -Tumor progression or recurrence on standard of care therapy, including ≥ 1 systemic therapy or be a patient for whom standard of care therapy is contraindicated.
    Treatment Group 2, Group 4, Group C, or Group F:
    -Documentation of confirmed HPV 16+ cancer via genotype testing
    -Tumor progression or recurrence on standard of care therapy, including ≥ 1 systemic therapy
    -Safe and accessible tumor site amenable for biopsy and IT administration
    -Apart from the tumor site(s) amenable for biopsy and IT administration ≥ 1 measurable lesion for RECIST assessment
    - Female patients who are of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test prior to the first administration of study treatment or be surgically/biologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal.
    - Male patients with sexual partners of childbearing potential can participate in the study if they agree to use barrier contraception from signing of the ICF through 5 months after the last study treatment administration.
    Treatment Group B or Group E:
    -Documentation of confirmed HPV 16+ HNSCC via genotype testing
    -Must be eligible, as per standard of care, to receive pembrolizumab
    Todos los pacientes:
    -18 años o más de edad
    -≥ 1 lesión medible por imagen para respuesta tumoral siguiendo los criterios RECIST e iRECIST
    -Estado general de 0 a 1 del Grupo oncológico cooperativo del este (ECOG)
    -La radioterapia curativa anterior debe haberse completado ≥4 semanas antes de la administración del tratamiento del estudio. La radioterapia paliativa localizada previa debe haberse completado ≥2 semanas antes de la administración del tratamiento del estudio
    -Los valores analíticos de la selección deben cumplir los criterios especificados en el protocolo para los grupos de tratamiento 1, 3, 4, 5, A, ó D:
    -Diagnóstico de cáncer CCECC VPH 16+ confirmado mediante análisis de genotipo
    -Progresión o recurrencia del tumor con el tratamiento habitual, incluido ≥1 tratamiento general o ser un paciente para el que el tratamiento de referencia esté contraindicado.
    Grupos de tratamiento 2, 4, C, ó F:
    -Diagnóstico de cáncer VPH 16+ confirmado mediante análisis de genotipo
    -Progresión o recurrencia del tumor con el tratamiento habitual, incluido ≥1 tratamiento general
    -Tejido tumoral en zona segura y accesible para biopsia y administración IT
    -≥ 1 lesión medible por criterios RECIST
    -Las pacientes en edad fértil deben mostrar un resultado negativo en la prueba de embarazo de gonadotropina coriónica humana β en suero (GCH-β) previa a la primera administración del tratamiento del estudio o estar esterilizadas quirúrgicamente (histerectomía u ovariectomía bilateral) o ser biológicamente estériles o posmenopáusicas.
    -Los pacientes de sexo masculino con parejas en edad fértil pueden participar en el estudio si aceptan utilizar un método anticonceptivo de barrera desde la firma del FCI hasta 5 meses después de la última dosis del tratamiento del estudio.
    Grupos de tratamiento B ó E:
    -Diagnóstico de cáncer CCECC VPH 16+ confirmado mediante análisis de genotipo
    -Debe ser apto para recibir pembrolizumab
    E.4Principal exclusion criteria
    -Untreated and/or symptomatic metastatic central nervous system (CNS) disease, and/or carcinomatous meningitis. With some exceptions
    for treated and stable brain/CNS metastases
    -Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation /
    treatment administration
    -Concurrent malignancy that is clinically significant or requires active intervention
    -Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy
    -Toxicity attributed to systemic prior anticancer therapy, including radiation and surgery, other than alopecia and fatigue that has not
    resolved to Grade 1 or Baseline prior to the first administration of study
    -Not meeting the protocol-specified washout periods for prohibited medications per the protocol
    -Treatment with any chemotherapy, biological, or investigational therapy for cancer within 28 days of the first administration of study treatment.,
    unless agreed otherwise between the Sponsor and the Investigator on a case-by-case basis based on the half-life of the anticancer therapy.
    Exception: Ongoing treatment with pembrolizumab is permitted if the subject is enrolling in a backfill cohort continuing pembrolizumab and
    adding either HB-201 monotherapy or HB-201 & HB-202 alternating two vector therapy.
    -Prior anaphylactic or other severe reaction to human immunoglobulin or
    antibody formulation administration
    -Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
    antibody, indicating acute or chronic infection
    -Known history of AIDS.
    For patients receiving pembrolizumab:
    -History of severe hypersensitivity reaction to pembrolizumab
    -Any contraindication to receiving pembrolizumab per package insert or
    SmPC
    -Allogeneic tissue/solid organ transplant.
    -History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
    -Pacientes con enfermedad metastásica del sistema nervioso central (SNC) o meningitis carcinomatosa sin tratar o sintomática. Con algunas excepciones para metástasis tratadas y estables en el cerebro/SNC
    -Cualquier trastorno médico grave o no controlado que, en opinión del investigador, pueda aumentar el riesgo asociado con la participación en el estudio o la administración del tratamiento del estudio
    -Neoplasia maligna importante desde el punto de vista clínico o que requiere intervención activa
    -Trastornos autoinmunitarios o inflamatorios activos, conocidos o sospechosos, que requieran tratamiento inmunodepresor
    -Toxicidad atribuida a un tratamiento antineoplásico general previo, incluidas radioterapia y cirugía diferente a la alopecia y cansancio que no se haya restaurado a grado 1 o a la situación inicial antes de la primera administración del tratamiento del estudio.
    -No cumplir con los periodos de lavado especificados en el protocolo para medicación prohibida por protocolo
    -Tratamiento oncológico con cualquier quimioterapia, biológico o en investigación en los 28 días anteriores a la primera administración del tratamiento del estudio, a menos que se acuerde lo contrario entre el promotor y el investigador caso por caso, en función de la semivida del tratamiento antineoplásico.
    Excepción: Se permite el tratamiento continuo con pembrolizumab si el sujeto se inscribe en una cohorte de sujetos adicionales que continúa con pembrolizumab y se añade HB-201 en monoterapia o tratamiento de dos vectores con HB-201 y HB-202 alternados.
    -Reacción anafiláctica anterior u otra reacción grave a la administración de la inmunoglobulina humana o la formulación de anticuerpos
    -Resultado positivo en la prueba de detección del antígeno de superficie de la hepatitis B (HBsAg) o del anticuerpo del virus de la hepatitis C (VHC), que indique una infección aguda o crónica.
    -Antecedentes conocidos de SIDA
    Para los pacientes que reciben pembrolizumab:
    -Antecedentes de reacción de hipersensibilidad grave al pembrolizumab
    -Cualquier contraindicación a recibir el pembrolizumab según el prospecto o el RCP.
    -Alotrasplante de vísceras macizas/tejido.
    -Antecedentes de neumonitis (no infecciosa), que precisó corticoesteroides o neumonitis en curso.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I Dose Escalation
    •Incidence of DLTs from the first study drug administered during the DLT observation period

    Phase II Dose Expansion
    Tumor responses will be assessed using RECIST and iRECIST by the Investigator:
    •Objective response rate
    •Disease control rate
    Fase I de aumento de la dosis
    •Incidencia de las TLD desde el primer fármaco del estudio administrado durante el periodo de observación de las TLD

    Fase II de expansión de la dosis
    El investigador evaluará las remisiones tumorales mediante los criterios RECIST e iRECIST:
    •Tasa total de remisión
    •Tasa de control de la enfermedad
    E.5.1.1Timepoint(s) of evaluation of this end point
    continuous
    continuo
    E.5.2Secondary end point(s)
    Phase I Dose Escalation
    •Safety: type, frequency, and severity of AEs and SAEs
    •Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values
    •Tumor responses will be assessed using RECIST and iRECIST by the Investigator:
    -Objective response rate
    -Disease control rate

    Phase II Dose Expansion
    Tumor responses will be assessed using RECIST and iRECIST by the Investigator:
    •Overall survival
    •Progression-free survival
    •Duration of response

    •Safety: type, frequency, and severity of AEs and SAEs
    •Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values
    Fase I de aumento de la dosis
    •Seguridad: tipo, frecuencia e intensidad de los AA y AAG
    •Tolerabilidad: interrupciones de la dosis, reducciones e intensidad de la dosis y evaluaciones de los valores analíticos
    •El investigador evaluará las remisiones tumorales mediante los criterios RECIST e iRECIST:
    -Tasa total de remisión
    -Tasa de control de la enfermedad
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuous
    continuo
    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 No
    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.7.1.3.1Other 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial12
    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 EEA15
    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
    United States
    European Union
    United Kingdom
    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 study will end when long-term follow up (including progression-free survival and/or overall survival) has been completed for all patients as described in Section 6.1.5, or in the event of early termination of the study (Section 3.3).
    El estudio finalizará cuando se haya completado el seguimiento a largo plazo (incluida la supervivencia libre de progresión y / o la supervivencia global) para todos los pacientes, como se describe en la Sección 6.1.5, o en el caso de la finalización anticipada del estudio (Sección 3.3).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 50
    F.4.2.2In the whole clinical trial 200
    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 Decision2021-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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