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    EudraCT Number:2019-003456-36
    Sponsor's Protocol Code Number:CL1-95012-001
    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
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-003456-36
    A.3Full title of the trial
    A first in human Phase 1/2 open-label, multicenter, dose escalation and expansion study of PRS-344/S095012 in patients with solid tumors
    Estudio de primera administración en humanos de fase I/II, abierto, multicéntrico, de escalada de dosis y expansión con PRS-344/S095012 en pacientes con tumores sólidos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of PRS-344/S095012 (PD-L1x4-1BB bispecific antibody) in patients with solid tumors
    Estudio con PRS-344/S095012 (anticuerpo biespecífico PPD-L1x4-1BB) en pacientes con tumores sólidos
    A.4.1Sponsor's protocol code numberCL1-95012-001
    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 SponsorInstitut de Recherches Internationales Servier
    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 supportLaboratorios Servier S. L.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier S.L.
    B.5.2Functional name of contact pointDpto. de Investigación y Desarrollo
    B.5.3 Address:
    B.5.3.1Street AddressAv. de Los Madroños 33
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.4Telephone number+34917489662
    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 nameS095012
    D.3.2Product code S095012
    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 INNS095012/PRS-344
    D.3.9.2Current sponsor codeS095012
    D.3.9.3Other descriptive namePRS-344
    D.3.9.4EV Substance CodeSUB207152
    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. 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 and/or metastatic solid tumors
    Tumores sólidos avanzados y/o metastásicos
    E.1.1.1Medical condition in easily understood language
    Solid tumors
    tumores sólidos
    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 10065252
    E.1.2Term Solid 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
    Phase 1:
    To evaluate the safety and tolerability profile of single-agent PRS-344/S095012
    To determine the maximum tolerated dose (MTD) if determined, or maximum administered dose (MAD) of PRS-344/S095012

    Phase 2:
    To evaluate the anti-tumor activity and efficacy of PRS-344/S095012, based on appropriate clinical standards for the specified tumor type.
    Fase 1 :
    -Evaluar el perfil de seguridad y tolerabilidad del agente único PRS-344/S095012
    -Determinar la dosis máxima tolerada (DMT) o la dosis máxima administrada (MAD) de PRS-344/S095012

    Fase 2:
    -Evaluar la actividad antitumoral y la eficacia de PRS-344/S095012, basándose en las normas clínicas apropiadas para el tipo de tumor especificado.
    E.2.2Secondary objectives of the trial
    Phase 1:
    To characterize the pharmacokinetics (PK) of PRS-344/S095012
    To evaluate the immunogenicity of PRS 344/S095012
    To assess the preliminary anti-tumor activity of PRS-344/S095012 as per RECIST v1.1

    Phase 2:
    To further describe the efficacy, through survival, duration of responses, clinical benefit
    To further characterize the safety and tolerability of PRS-344/S095012 in specific indications
    To further characterize the PK profile of PRS-344/S095012
    To evaluate those biomarkers potentially predictive of response from tumor and blood samples
    Fase 1 :
    - Caracterizar la farmacocinética (PK) de PRS-344/S095012
    - Evaluar la inmunogenicidad de PRS 344/S095012
    - Evaluar la actividad antitumoral preliminar de PRS-344/S095012 según RECIST v1.1.

    Fase 2 :
    - Descripción ampliada de la eficacia, a través de la supervivencia, la duración de las respuestas, el beneficio clínico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years on the day the consent is signed.
    2. Dose escalation and back-fill cohorts: Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
    3. Patient should have a documented disease progression on prior therapy before entry into this study.
    4. Patients must have at least one measurable target lesion as per RECIST 1.1
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    6. Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
    7. Adequate organ function as assessed by laboratory tests within 72 hours prior to the start of treatment.

    Dose Expansion:
    8. Patients who have had prior checkpoint inhibitor (CPI) treatment in the past 6 months must have documented confirmed radiographic progression from it prior to study entry.
    9. Patients with histologically diagnosed extensive stage small cell lung cancer or locally advanced or metastatic squamous cell carcinoma of the esophagus.
    10. Patients must have received and progressed on only one prior regimen in the metastatic setting comprising an PD-(L)1 plus chemotherapy.
    1. Edad ≥18 años el día de la firma del consentimiento.
    2. Cohortes de escalada de dosis y relleno: Pacientes con diagnóstico histológicamente confirmado de tumor sólido irresecable, localmente avanzado o metastásico para el que las opciones de tratamiento estándar no están disponibles, ya no son eficaces o no se toleran.
    3. El paciente debe tener una progresión documentada de la enfermedad con la terapia anterior antes de entrar en este estudio.
    4. Los pacientes deben tener al menos una lesión diana medible según RECIST 1.1
    5. Estado de rendimiento del Eastern Cooperative Oncology Group (ECOG) de 0 o 1
    6. Los pacientes que no dispongan de tejido biopsiado archivado deben tener una o más lesiones tumorales susceptibles de biopsia.
    7.Función orgánica adecuada evaluada mediante pruebas de laboratoio en las 72h anteriores al inicio del tratamiento

    Expansión de la dosis:
    8. Los pacientes que hayan recibido un tratamiento previo con inhibidores de puntos de control (IPC) en los últimos 6 meses deben tener documentada la progresión radiográfica ntes de la entrada en el estudio.
    9. Pacientes con cáncer de pulmón de células pequeñas en estadio avanzado diagnosticado histológicamente o carcinoma de células escamosas localmente avanzado o metastásico del esófago.
    10. Los pacientes deben haber recibido y progresado con un solo régimen previo en el estadio metastásico que comprenda un PD-(L)1 más quimioterapia.
    E.4Principal exclusion criteria
    1. Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid<10 mg/day prednisone or equivalent) is allowed
    2. Patients who have received prior:
    a. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
    b. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.
    c. Radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.
    3. Patients who have received 4-1BB agonists in the past.
    4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.

    Dose Expansion:
    5. Patient who received therapy with an irinotecan containing regimen
    6. Patients must not be on warfarin, strong cytochrome P450 (CYP) 3A4 inducers, strong CYP3A4 inhibitors, or strong UGT1A1 inhibitors.
    1. Los pacientes con metástasis cerebrales previamente tratadas pueden participar siempre que estén radiológicamente estables, clínicamente asintomáticos y estén fuera de las terapias inmunosupresoras durante al menos 4 semanas. Se permite una dosis baja de esteroides<10 mg/día de prednisona o equivalente.
    2. Pacientes que han recibido previamente:
    a. Inhibidores de molécula pequeña, y/u otro agente de investigación similar: ≤ 2 semanas o 5 vidas medias, lo que sea más corto.
    b. Quimioterapia, otros anticuerpos monoclonales, conjugados anticuerpo-fármaco u otras terapias experimentales similares: ≤ 3 semanas o 5 vidas medias, lo que sea más corto.
    c. Radioinmunoconjugados u otras terapias experimentales similares ≤ 6 semanas o 5 semividas, lo que sea más corto
    3. Pacientes que hubieran recibido agonistas 4-1BB en el pasado.
    4. Pacientes que hubieran sido intervenidos de cirugía mayor en las 4 semanas previas a la primera administración de IMP

    Expansión de dosis:
    5. Paciente que haya recibido tratamiento con un régimen conteniendo irinotecan.
    6. Los pacientes no deben estar tomando warfarina, inductores potentes del citocromo P450 (CYP) 3A4, inhibidores potentes de CYP3A4 o de UGT1A1.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    Incidence of dose-limiting toxicities (DLTs)
    Incidence and severity of adverse events (AEs)
    Discontinuing study treatment due to an AE
    Laboratory, ECG and vital sign measurements

    Phase 2:
    Objective Response Rate (ORR) : proportion of patients who have Complete Response (CR) or Partial Response (PR)
    Fase 1 :
    - Incidencia de toxicidades limitantes de la dosis (TLD)
    - Incidencia y gravedad de los acontecimientos adversos (AA)
    - Interrupción del tratamiento del estudio debido a un AA
    - Mediciones de laboratorio, ECG y signos vitales

    Fase 2 :
    - Tasa de respuesta objetiva (ORR): Definida como la proporción de pacientes que tienen Respuesta Completa (RC) o Respuesta Parcial (RP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT: End of cycle 1
    Others: All along the study
    TLD : fin del ciclo 1
    Otros : durante todo el estudio
    E.5.2Secondary end point(s)
    Phase 1:
    Serum PK parameters of PRS-344/S095012
    Presence of antidrug antibody (ADA), ORR
    Duration of Response (DOR): time from first demonstration of response to progression or death, whichever occurs first.
    Progression-free Survival (PFS): time from the first dose of treatment to first documented disease progression or death due to any cause, whichever occurs first.
    Overall Survival (OS): time from first dose of study drug to death due to any cause.

    AEs, SAEs, Laboratory, ECG, vital signs
    Serum PK parameters of PRS-344/S095012
    PD-L1, 4-1BB, and CD8 expression in the tumor
    Tumor mutational burden (TMB), in the tumor and/or blood, MSI status, specific mutations
    Gene expression profiling in the tumor and/or blood
    Fase 1 :
    - Parámetros PK de PRS-344/S095012 en suero
    - Presencia de anticuerpos antifármaco (ADA) , ORR
    - Duración de la respuesta (DOR): tiempo transcurrido desde la primera demostración de respuesta hasta la progresión o la muerte, lo que ocurra primero.
    - Supervivencia libre de progresión (SLP): tiempo transcurrido desde la primera dosis de tratamiento hasta la primera progresión documentada de la enfermedad o la muerte por cualquier causa, lo que ocurra primero
    - Supervivencia global (SG): tiempo transcurrido desde la primera dosis del fármaco del estudio hasta la muerte por cualquier causa.

    Fase 2 :
    - DCR, DOR, PFS, OS
    - AAs, AAGs, Laboratorio, ECG, signos vitales
    - Parámetros PK séricos de PRS-344/S095012
    - Expresión de PD-L1, 4-1BB y CD8 en el tumor
    - Carga mutacional del tumor (TMB), en el tumor y/o en la sangre, estado MSI, mutaciones específicas
    - Perfil de expresión génica en el tumor y/o en la sangre
    E.5.2.1Timepoint(s) of evaluation of this end point
    All along the study
    Durante todo el estudio
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    First in human - combined phase I/II
    Primero en humano - combinado faseI/II
    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 Yes
    E. trial design description
    Fase I/II
    Phase I/II
    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 trial1
    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 EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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 is defined as the last patient’s last visit, which includes the long-term safety follow-up visit, 90 days after the last dose of IMP or the last contact attempt if the last participant is declared lost to follow-up.
    El final del estudio se define como la última visita del último paciente, incluida la visita de seguimiento de seguridad, 90 días después de la última dosis del fármaco del estudio o la fecha del último intento de contacto si el paciente se declara perdido para el seguimiento.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 161
    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)
    The participants' treatment is left to the physician's discretion. As the study drug is not licensed yet at this time, it will not be available on the market.
    El tratamiento del paciente se deja a la discreción del médico. Como el fármaco del estudio aún no está autorizado en este momento, no estará disponible en el mercado.
    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 Decision2021-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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