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    Summary
    EudraCT Number:2022-001596-14
    Sponsor's Protocol Code Number:TYR300-101
    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 number2022-001596-14
    A.3Full title of the trial
    A Multicenter, Open-label Phase 1/2 Study of TYRA 300 in Advanced Urothelial Carcinoma and Other Solid Tumors with Activating FGFR3 Gene Alterations (SURF 301)
    Estudio multicéntrico, abierto, de fase I/II sobre el uso de TYRA‑300 en el carcinoma urotelial avanzado y otros tumores sólidos con alteraciones activadoras en el gen FGFR3 (SURF-301)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open-label Phase 1/2 Study of TYRA 300 in Advanced Urothelial Carcinoma and Other Solid Tumors
    Estudio multicéntrico, abierto, de fase I/II sobre el uso de TYRA‑300 en el carcinoma urotelial avanzado y otros tumores sólidos
    A.3.2Name or abbreviated title of the trial where available
    SURF 301
    SURF 301
    A.4.1Sponsor's protocol code numberTYR300-101
    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 SponsorTyra Biosciences, Inc.
    B.1.3.4CountryUnited States
    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 supportTyra Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials Limited
    B.5.2Functional name of contact pointElicia Castaneda
    B.5.3 Address:
    B.5.3.1Street Address600 Park Offices Drive, Suite 200
    B.5.3.2Town/ cityResearch Triangle Park
    B.5.3.3Post codeNC 27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1210640.5636
    B.5.6E-mailelicia.castaneda@worldwide.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.3.2Product code TYRA-300
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.3Other descriptive nameTYRA-300-B01
    D.3.9.4EV Substance CodeSUB297606
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Urothelial Carcinoma and Other Solid Tumors with Activating FGFR3 Gene Alterations
    carcinoma urotelial avanzado y otros tumores sólidos con alteraciones activadoras en el gen FGFR3
    E.1.1.1Medical condition in easily understood language
    Advanced Urothelial Carcinoma and Other Solid Tumors
    carcinoma urotelial avanzado y otros 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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    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
    • To determine the optimal and MTDs, and RP2D of TYRA-300 in participants with advanced solid tumors (Phase 1, Parts A and B)
    • To evaluate the preliminary antitumor activity of TYRA-300 at the RP2D in participants in selected tumor expansion cohorts with activating FGFR3 gene alterations (Phase 2)
    • Determinar la dosis óptima, la dosis máxima tolerada (DMT) y la dosis recomendada para la fase II (DRFII) de TYRA‑300 en participantes con tumores sólidos avanzados (partes A y B de la fase I).
    • Evaluar la actividad antineoplásica preliminar de TYRA‑300 a la DRFII en participantes de cohortes de ampliación de la dosis con tumores seleccionados y alteraciones activadoras en el gen del receptor 3 del factor de crecimiento fibroblástico (FGFR3, por su sigla en inglés) (fase II).
    E.2.2Secondary objectives of the trial
    • To characterize the safety and tolerability of TYRA-300 in participants with advanced cancer (Phase 1, Parts A and B, and Phase 2)
    • To conduct a preliminary characterization of the pharmacokinetics (PK) and pharmacodynamics in participants treated with TYRA-300 (Phase 1, Parts A and B, and Phase 2)
    • To characterize ORR in participants with activating FGFR3 gene alterations (Phase 1, Part B)
    • To characterize DOR (Phase 1, Part B and Phase 2)
    • To characterize DCR >12 weeks (Phase 1, Part B and Phase 2)
    • To characterize TTR (Phase 1, Part B and Phase 2)
    • To characterize PFS in participants treated with TYRA-300 in specific tumor expansion cohorts (Cohorts 1 and 2 of Phase 2 only)
    • Caracterizar la seguridad y la tolerabilidad de TYRA‑300 en participantes con cáncer avanzado (partes A y B de la fase I y fase II).
    • Realizar una caracterización preliminar de la farmacocinética (FC) y la farmacodinámica (FD) de TYRA‑300 en participantes tratados con el fármaco (partes A y B de la fase I y fase II).
    • Caracterizar la tasa global de remisión (TGR) en participantes con alteraciones activadoras en el gen FGFR3 (parte B de la fase I).
    • Caracterizar la duración de la remisión (DdR) (parte B de la fase I y fase II).
    • Caracterizar la tasa de control de la enfermedad (TCE) tras 12 semanas (parte B de la fase I y fase II).
    • Caracterizar el tiempo transcurrido hasta la obtención de una remisión (TTR) (parte B de la fase I y fase II).
    • Caracterizar la supervivencia sin progresión (SSP) en participantes con tumores seleccionados tratados con TYRA‑300 en cohortes de ampliación de la dosis (exclusivamente cohortes 1 y 2 de la fase II).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase 1, Part A
    1. Male and female participants who are 18 years of age or older on the day of signing the ICF.
    2. Life expectancy >12 weeks.
    3. Ability to understand and sign the ICF and comply with study procedures.
    4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1.
    Note: Refer to Appendix 14.4 for ECOG PS.
    5. Participants with any histologically confirmed advanced solid tumor who have exhausted standard therapeutic options.
    6. Ability to swallow capsules.
    7. Disease evaluable by RECIST v1.1.
    8. Adequate organ and bone marrow function
    9. Participants and their partners should practice contraception and reproduction restrictions of the study
    10. Negative test result for COVID-19

    Phase 1, Part B
    1. Male and female participants who are 18 years of age or older on the day of signing the ICF.
    2. Life expectancy >12 weeks.
    3. Ability to understand and sign the ICF and comply with study procedures.
    4. ECOG PS ≤1.
    5. Participants with any histologically confirmed advanced solid tumor who have exhausted standard therapeutic options.
    6. Ability to swallow capsules.
    7. At least 1 measurable lesion by RECIST v1.1.
    8. Adequate organ and bone marrow function
    9. Participants and their partners should practice contraception and reproduction restrictions of the study
    10. Negative test result for COVID-19

    Phase 2
    1. Male and female participants who are 12 years of age or older on the day of signing the ICF.
    2. Life expectancy >12 weeks.
    3. Ability to understand and willingness to sign the ICF. For participants under 18 years of age (or country equivalent), a parent/legal guardian with the ability to understand and sign the informed consent and the child with the ability to understand and sign the Assent Form.
    4. ECOG PS 0 to 2. KPS >70 for participants aged 12 to 17 years.
    Note: Refer to Appendix 14.4 for ECOG PS and Appendix 14.8 for KPS.
    5. Participants must have a histologically confirmed locally advanced/metastatic tumor in 1 of the following categories:
    a. Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who have progressed on a prior FGFR inhibitor and presence of a resistance mutation or other kinase domain mutation likely to respond to TYRA-300 identified using the CTA or an FDA authorized/approved CDx or a CLIA (or regional equivalent) validated local test performed in a certified laboratory.
    b. Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement identified by the central CTA or an FDA authorized/approved CDx or a CLIA (or regional equivalent) validated local test performed in a certified laboratory who have not received a prior FGFR inhibitor.
    c. Any solid tumor with an eligible FGFR3 gene mutation or rearrangement identified via an authorized/approved or CLIA (or regional equivalent) validated local test result in a certified laboratory.
    i. With medical monitor approval, participants who progressed on a prior FGFR inhibitor may be enrolled if they have a documented FGFR3 resistance mutation or other kinase domain mutation for which TYRA-300 is likely to be active based on preclinical studies.
    6. Ability to swallow capsules.
    7. At least 1 measurable lesion by RECIST v1.1.
    8. Adequate organ and bone marrow function
    10. Negative test result for COVID-19
    Parte A de la fase I
    1.Participantes de sexo masculino y femenino a partir de los 18 años el día de la firma del documento de consentimiento informado (DCI).
    2. Esperanza de vida >12 semanas.
    3. Capacidad para entender y firmar el DCI y cumplir los procedimientos del estudio.
    4. Puntuación ECOG PS ≤1.
    Nota: Ver apéndice 14.4 para ECOG PS.
    5. Participantes con cualquier tumor sólido avanzado confirmado mediante un estudio histológico que hayan agotado todas las opciones de tratamiento habitual.
    6. Capacidad para tragar cápsulas.
    7. Enfermedad evaluable mediante los criterios RECIST v1.1.
    8. Función orgánica y medular adecuada.
    9. Los/las participantes y sus parejas deberán utilizar medidas anticonceptivas y aplicar las restricciones reproductivas del estudio
    10. Resultado negativo para la enfermedad por coronavirus de 2019 (COVID 19)

    Parte B de la fase I
    1. Participantes de sexo masculino y femenino a partir de los 18 años el día de la firma del DCI.
    2. Esperanza de vida >12 semanas.
    3. Capacidad para entender y firmar el DCI y cumplir los procedimientos del estudio.
    4. Puntuación ECOG PS ≤1.
    5. Participantes con cualquier tumor sólido avanzado confirmado mediante un estudio histológico que hayan agotado todas las opciones de tratamiento habitual.
    6. Capacidad para tragar cápsulas.
    7. Al menos una lesión medible mediante los criterios RECIST v1.1.
    8. Función orgánica y medular adecuada
    9. Los/las participantes y sus parejas deberán utilizar medidas anticonceptivas y aplicar las restricciones reproductivas del estudio
    10. Resultado negativo para la COVID‑19
    Fase II
    1. Participantes de sexo masculino y femenino a partir de los 12 años el día de la firma del DCI.
    2. Esperanza de vida >12 semanas.
    3. Capacidad de entender y voluntad de firmar el DCI. En el caso de participantes menores de 18 años (o la edad legal en el país correspondiente), padre/madre/tutor(a) legal con capacidad de entender y firmar el documento de consentimiento informado y menor con capacidad de entender y firmar el documento de asentimiento.
    4. Puntuación ECOG PS de 0 a 2. Puntuación KPS >70 en el caso de participantes de 12 a 17 años.
    5. Los/las participantes deben presentar un tumor avanzado a nivel local/metastásico
    6. Capacidad para tragar cápsulas.
    7. Al menos una lesión medible mediante los criterios RECIST v1.1.
    8. Función orgánica y medular adecuada
    9. Los/las participantes y sus parejas deberán utilizar medidas anticonceptivas y aplicar las restricciones reproductivas del estudio,
    10. Resultado negativo para la COVID‑19
    E.4Principal exclusion criteria
    1. Participant received chemotherapy, targeted therapy, immunotherapy, or an investigational therapy within 2 weeks or 5 half-lives (within 6 weeks for nitrosoureas and mitomycin) before the first dose of study drug.
    2. Participant has not recovered from reversible toxicity of prior anticancer therapy (except toxicities that are not clinically significant including, but not limited to, alopecia, skin discoloration, or Grade 1 neuropathy).
    3. Had major surgery within 4 weeks prior to enrollment.
    4. Any reason that, in the view of the investigator, would substantially impair the ability of the participant to comply with study procedures and increase the risk to the participant. Examples include poorly controlled diabetes (glycated hemoglobin [HbA1c] >8%) and ongoing active infection requiring intravenous (IV) antibiotics.
    5. Females who are pregnant, breastfeeding, or planning to become pregnant within 120 days after the last dose of TYRA-300 and males who plan to father a child while enrolled in this study or within 120 days after the last dose of TYRA-300.
    6. Has impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions.
    7. Has a serum phosphorus level >ULN during screening (within 14 days of treatment and prior to Cycle 1, Day 1) that remains >ULN despite medical management with phosphate binders.
    8. Any ocular condition likely to increase the risk of eye toxicity, including:
    a. History of or current evidence of central serous retinopathy (CSR; including ≥Grade 2 CSR while receiving a prior FGFR inhibitor) or retinal vascular occlusion (RVO).
    b. Active wet, age-related macular degeneration (AMD).
    c. Diabetic retinopathy with macular edema.
    d. Uncontrolled glaucoma (per local standard of care).
    9. History of or current uncontrolled cardiovascular disease including:
    a. Unstable angina, myocardial infarction, or known congestive heart failure Class II to IV within the preceding 12 months.
    b. Cerebrovascular accident or transient ischemic attack within the preceding 3 months.
    c. Pulmonary embolism within the preceding 2 months.
    10. Active, symptomatic, or untreated brain metastases.
    a. Prior brain metastases treated at least 3 weeks prior to signing the full-study ICF or that are clinically and radiographically stable for at least 1 month prior to Cycle 1, Day 1 and do not require chronic corticosteroid treatment are allowed.
    11. Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300.
    12. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
    a. Participants with a history of HIV on antiviral therapy with undetectable viral load by PCR are allowed.
    b. Participants with a history of hepatitis B virus infection with positive hepatitis B surface antibody, or positive hepatitis B core antibody with a negative PCR test, are allowed.
    c. Participants with hepatitis C infection previously treated with antiviral therapy and negative for hepatitis C virus by PCR are allowed.
    13. History of a second primary malignancy within 3 years of signing the ICF (except definitively treated early-stage cancer such as resected skin cancers and/or completely resected prostate cancer).
    14. Known allergy to TYRA-300 or any excipients of the formulated product.
    15. Participants taking strong inhibitors and/or inducers of CYP3A4 enzymes are prohibited.
    a. Participants who can switch to a similar medication without a CYP3A4 interaction will require a washout period of 2 weeks prior to starting TYRA-300.
    1. El/la participante recibió quimioterapia, una terapia dirigida, inmunoterapia o un tratamiento en investigación en las 2 semanas o 5 semividas (6 semanas en el caso de nitrosoureas y mitomicina) anteriores a la administración de la primera dosis del fármaco en estudio.
    2. El/la participante no se recuperó de la toxicidad reversible de un tratamiento antineoplásico anterior (a excepción de toxicidades que carecen de trascendencia clínica, como la alopecia, el cambio de color de la piel o la neuropatía de grado 1).
    3. El/la participante se sometió a cirugía mayor en las 4 semanas anteriores al momento de la inscripción.
    4. Cualquier motivo que, en opinión del/de la investigador/a, podría afectar de forma considerable a la capacidad del/de la participante de cumplir los procedimientos del estudio y aumentar el riesgo para dicho/a participante, como una diabetes mal controlada (niveles de hemoglobina glucosilada [HbA1c] >8 %) y una infección activa en curso que requiera tratamiento antibiótico por vía intravenosa (i.v.).
    5. Mujeres embarazadas, en período de lactancia o que planean quedarse embarazadas en los 120 días anteriores a la administración de la última dosis de TYRA‑300 y hombres que planean engendrar un bebé mientras participan en este estudio o en los 120 días después de recibir la última dosis de TYRA‑300.
    6. Capacidad de cicatrización de heridas disminuida definida como la presencia de úlceras de piel/decúbito, úlceras crónicas en las piernas, úlceras gástricas conocidas o incisiones sin cicatrizar.
    7. Niveles de fósforo sérico superiores al LSN durante la fase de selección (en los 14 días anteriores al inicio del tratamiento y antes del día 1 del ciclo 1) que continúan siendo más elevados que el LSN a pesar de su tratamiento médico con quelantes de fosfato.
    8. Cualquier afección ocular que pueda aumentar el riesgo de una toxicidad ocular, entre ellos:
    a. Antecedentes o pruebas actuales de una retinopatía serosa central (RSC), incluida una RSC de grado ≥2 durante el transcurso de un tratamiento anterior con un inhibidor del FGFR, o una oclusión vascular retiniana (OVR).
    b. Degeneración macular senil (DMS) húmeda activa.
    c. Retinopatía diabética con edema macular.
    d. Glaucoma no controlado (según el tratamiento de referencia local).
    9. Antecedentes de cardiopatía o cardiopatía actual no controlada, entre ellos:
    a. Angina de pecho inestable, infarto de miocardio o insuficiencia cardíaca congestiva conocida de clase II a IV en los últimos 12 meses.
    b. Accidente cerebrovascular o accidente isquémico transitorio en los 3 meses anteriores.
    c. Embolia pulmonar en los 2 meses anteriores.
    10. Metástasis cerebrales activas, sintomáticas o no tratadas.
    a. Se permiten las metástasis cerebrales anteriores tratadas al menos 3 semanas antes de la firma del DCI del estudio completo o que se hayan mantenido estables desde un punto de vista clínico y radiográfico durante al menos 1 mes antes del día 1 del ciclo 1 y que no requieran tratamiento crónico con corticoides.
    11. Trastornos gastrointestinales que afectarían a la administración oral o la absorción de TYRA‑300.
    12. Antecedentes conocidos de una infección por el virus de la inmunodeficiencia humana (VIH) o infección activa por hepatitis B o C.
    a. Se permite la inclusión de participantes con antecedentes de VIH que estén recibiendo tratamiento antiviral y que presenten una carga vírica indetectable mediante una prueba de PCR.
    b. Se permite la inclusión de participantes con antecedentes de una infección por el virus de la hepatitis B con positividad para el anticuerpo de superficie de la hepatitis B o con positividad para el anticuerpo del núcleo de la hepatitis B y una prueba PCR negativa.
    c. Se permite la inclusión de participantes con una infección por hepatitis C que hayan recibido un tratamiento antiviral previo y que presenten una prueba PCR negativa para el virus de la hepatitis C.
    13. Antecedentes de una segunda neoplasia primaria en los 3 años anteriores a la firma del DCI (a excepción de un cáncer incipiente tratado de forma definitiva, como los cánceres de piel resecados o el cáncer de próstata extirpado por completo).
    14. Alergia conocida a TYRA‑300 o a cualquier excipiente del producto formulado.
    15. Se prohíbe la participación de participantes que consuman inhibidores o inductores potentes de enzimas del citocromo P450 (CYP3A4).
    a. Los/las participantes que puedan cambiar a un medicamento similar sin que se produzca una interacción con el CYP3A4 tendrán que completar un período de reposo farmacológico de 2 semanas antes de iniciar el tratamiento con TYRA 300.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for Phase 1 (Parts A and B) is:
    • Incidence of DLT events during the DLT evaluation period (Cycle 1 [28 days])
    The primary endpoint for Phase 2 is:
    • Investigator-assessed ORR, defined as either a complete response (CR) or a partial response (PR) by RECIST v1.1
    Fase I (partes A y B): incidencia de acontecimientos de TLD durante el período de evaluación de TLD (ciclo 1 [28 días]).
    Fase II: TGR evaluada por el/la investigador/a y definida por una RC o una RP conforme a los criterios RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various
    Varios
    E.5.2Secondary end point(s)
    The secondary endpoints for Phase 1 (Parts A and B) and Phase 2 are:
    • Incidence of AEs characterized by study phase, cohort, seriousness, relationship to study drug, timing, and severity
    • Changes in clinical laboratory parameters, vital signs, ECG parameters, and physical examination status
    • Single-dose and steady-state PK parameters, including but not limited to accumulation ratio, Cmax, Tmax, AUC0-last, AUCTau, AUC0-∞(after first dose only), Vd/F, CL/F, and t1/2
    Additional secondary endpoint for Phase 1, Part B only:
    • ORR
    Additional secondary endpoints for Phase 1, Part B and Phase 2:
    • DOR
    • DCR, defined as CR, PR, or stable disease (SD) for >12 weeks
    • TTR
    Additional secondary endpoint for Phase 2 only:
    • PFS in Cohorts 1 and 2.
    Fase I (partes A y B) y fase II:
    • Incidencia de AA caracterizada por fase del estudio, cohorte, gravedad, relación con el fármaco en estudio, momento de aparición e intensidad.
    • Cambios en los parámetros analíticos, las constantes vitales, los parámetros electrocardiográficos (ECG) y la exploración física.
    • Parámetros FC tras una única dosis y en estado de equilibrio, entre ellos, el coeficiente de acumulación, la concentración máxima (Cmáx), el tiempo máximo (Tmáx), el área bajo la curva desde el momento cero hasta la última concentración medible (AUC0-last, por su sigla en inglés), el área bajo la curva desde el momento cero hasta el final del período de administración de la dosis (AUCTau, por su sigla en inglés), área bajo la curva desde el momento cero hasta el infinito (AUC0-∞, por su sigla en inglés; exclusivamente tras la administración de la primera dosis), volumen de distribución aparente sobre la fracción biodisponible (Vd/F), aclaramiento aparente sobre la fracción biodisponible (CL/F) y semivida (t1/2).
    • Criterio secundario de valoración adicional para la fase I (parte B exclusivamente):
    o TGR
    • Criterios secundarios de valoración adicionales para las fases I (parte B) y II:
    o DdR
    o TCE, definida como una RC, RP o EE durante >12 semanas
    o TTR
    • Criterios secundarios de valoración adicionales exclusivamente para la fase II:
    o SSP en las cohortes 1 y 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various
    Varios
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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.8.3 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 EEA6
    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
    Australia
    Canada
    Korea, Republic of
    Taiwan
    United States
    France
    Netherlands
    Spain
    Czechia
    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 years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 310
    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
    Ninguno
    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 Decision2023-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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