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    Summary
    EudraCT Number:2021-003380-95
    Sponsor's Protocol Code Number:CDYP688A12101
    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:2022-07-27
    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 number2021-003380-95
    A.3Full title of the trial
    A Phase I/II, multi-center, open label study of DYP688 in patients with metastatic uveal melanoma (MUM) and other GNAQ/11 mutant melanomas
    Estudio de fase I/II, multicéntrico y abierto de DYP688 en pacientes con melanoma uveal metastásico (MUM) y otros melanomas con mutación GNAQ/11
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/II study of DYP688 treatment alone in patients with eye cancer and other types of cancers of the skin and mucosal membranes in the body
    Ensayo de fase I/II de DYP688 en monoterapia en pacientes con cáncer de ojo y otros tipos de cáncer de la piel y las membranas mucosas del cuerpo
    A.4.1Sponsor's protocol code numberCDYP688A12101
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 90 0353036
    B.5.5Fax number34 93 2479903
    B.5.6E-maileecc.novartis@novartis.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 nameDYP688
    D.3.2Product code DYP688
    D.3.4Pharmaceutical form Powder 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 INNNot established yet
    D.3.9.2Current sponsor codeDYP688
    D.3.9.3Other descriptive nameDYP688
    D.3.9.4EV Substance CodeSUB257572
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    MUM and other non-uveal, GNAQ/11 mutant melanomas
    MUM y otros melanomas no uveales con mutación GNAQ/11
    E.1.1.1Medical condition in easily understood language
    Metastatic Uveal Melanoma
    Melanoma Uveal Metastásico
    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 PT
    E.1.2Classification code 10081431
    E.1.2Term Uveal melanoma
    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 10027481
    E.1.2Term Metastatic melanoma
    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 HLT
    E.1.2Classification code 10030052
    E.1.2Term Ocular melanomas
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: To characterize the safety and tolerability and to identify the MTD and/or RD and regimen for future studies of DYP688 as a single agent
    Phase II: To evaluate the anti-tumor activity of DYP688 as a single agent
    Fase I: caracterizar la seguridad y la tolerabilidad e identificar la dosis máxima tolerada (MTD) y/o la dosis recomendada (DR) y la pauta posológica para futuros estudios de DYP688 en monoterapia.
    Fase II: evaluar la actividad antitumoral de DYP688 en monoterapia.
    E.2.2Secondary objectives of the trial
    Phase I
    •To characterize the pharmacokinetics (PK) of DYP688 as a single agent
    •To assess the immunogenicity (IG) of DYP688 as a single agent
    •To evaluate the preliminary anti-tumor activity of DYP688 as a single agent
    Phase II
    •To further evaluate the anti-tumor activity of DYP688 as a single agent
    •To evaluate overall survival of DYP688 as a single agent
    •To further characterize the safety and tolerability of DYP688 as a single agent
    •To further characterize the PK of DYP688 as a single agent
    Fase I
    - Caracterizar la farmacocinética (PK) de DYP688 en monoterapia.
    - Evaluar la inmunogenicidad (IG) de DYP688 en monoterapia.
    - Evaluar la actividad antitumoral preliminar de DYP688 en monoterapia
    Fase II
    - Evaluar más detalladamente la actividad antitumoral de DYP688 en monoterapia.
    - Evaluar la supervivencia global de DYP688 en monoterapia.
    - Caracterizar más detalladamente la seguridad y la tolerabilidad de DYP688 en monoterapia.
    - Caracterizar más detalladamente la PK de DYP688 en monoterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients in the dose escalation part must be ≥ 18 years of age at the time of informed consent (ICF) signature. In the phase II part, patients ≥ 12 years of age at the time of informed consent may be eligible for enrollment. Patients must have a minimum weight of 40 kg.
    2.ECOG performance status ≤ 1 for patients ≥ 18 years of age; Karnofsky performance status ≥ 70 for patients ≥ 16 and < 18 years of age; Lansky performance status ≥ 70 for patients ≥ 12 and < 16 years of age
    3.Patients must be suitable and willing to undergo study required biopsies according to the treating institution’s own guidelines and requirements, if medically feasible.
    For all patients in Dose Escalation
    4.MUM: uveal melanoma with histologically or cytologically confirmed metastatic disease. Patient must be either treatment naive or have received any number of prior lines and progressed on most recent therapy
    5.Non-MUM: advanced cutaneous or mucosal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 mutation based on local data
    For patients in Phase II
    6.Tebentafusp naïve group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies
    7.Tebentafusp pre-treated group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease. Patients must be previously treated with tebentafusp and have progressed
    8.Non-MUM: patients with diagnosis of cutaneous or mucosal melanomas harboring GNAQ/11 mutations based on local data, with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies

    Other protocol defined criteria may apply.
    1. Los pacientes de la parte de escalada de dosis deben tener >=18 años de edad en el momento de la firma del consentimiento informado (FCI). Los pacientes que tengan >=12 años de edad en el momento de la firma del consentimiento informado podrían ser aptos para participar en la fase II. Los pacientes deben tener un peso mínimo de 40 kg.
    2. Estado funcional ECOG <=1 en los pacientes que tengan >=18 años de edad; estado funcional de Karnofsky >=70 en los pacientes que tengan >=16 y <18 años; y estado funcional de Lansky >=70 en los pacientes que tengan >=12 y <16 años de edad.
    3. Los pacientes deben ser aptos y estar dispuestos a que se les realicen las biopsias necesarias para el estudio de acuerdo con las pautas y los requisitos del centro donde se lleve a cabo el tratamiento, si es viable desde un punto de vista médico.
    Para todos los pacientes de la escalada de dosis
    4. MUM: melanoma uveal con enfermedad metastásica confirmada histológica o citológicamente. El paciente debe o bien no haber recibido tratamiento o bien haber recibido cualquier número de líneas anteriores y haber progresado con el tratamiento más reciente
    5. Melanoma no uveal metastásico: melanoma cutáneo o mucoso avanzado con enfermedad metastásica confirmada histológica o citológicamente que haya progresado después de tratamientos estándares o para el que no haya tratamientos alternativos satisfactorios y presente evidencia de mutación GNAQ/11 basándose en datos locales.
    Para los pacientes de la fase II
    6. Grupo no tratado con tebentafusp: diagnóstico de melanoma uveal con enfermedad metastásica confirmada histológica o citológicamente que haya progresado después de tratamientos estándares o para el que no haya tratamientos alternativos satisfactorios.
    7. Grupo tratado previamente con tebentafusp: diagnóstico de melanoma uveal con enfermedad metastásica confirmada histológica o citológicamente. Los pacientes deben haber sido tratados previamente con tebentafusp y haber progresado.
    8. Melanoma no uveal metastásico: pacientes con diagnóstico de melanoma cutáneo o mucoso con mutación GNAQ/11, basándose en datos locales, con enfermedad metastásica confirmada histológica o citológicamente que haya progresado después de tratamientos estándares o para el que no haya tratamientos alternativos satisfactorios.

    Pueden aplicar otros criterios definidos por protocolo
    E.4Principal exclusion criteria
    1.Malignant disease, other than that being treated in this study.
    2.Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease.
    3.Evidence of active bleeding or bleeding diathesis or significant coagulopathy (including familial) or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
    4.History of anaphylactic or other severe hypersensitivity / infusion reactions to ADCs or monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
    5.Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
    •≤ 2 weeks for fluoropyrimidine therapy
    •≤ 4 weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment.
    •≤ 4 weeks or ≤ 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
    •≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosoureas and mitomycin C.
    •≤ 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.
    6.Clinically significant and / or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA grade ≥ 2) or clinically significant arrhythmia despite medical treatment.

    Other protocol defined criteria may apply.
    1. Enfermedad maligna distinta a la tratada en este estudio.
    2. Metástasis cerebrales activas, es decir, metástasis cerebrales sintomáticas o enfermedad leptomeníngea conocida.
    3. Evidencia de hemorragia activa, diátesis hemorrágica o coagulopatía significativa (incluida la coagulopatía familiar) o cualquier estado de salud que requiera anticoagulación sistémica a largo plazo que pueda interferir en las biopsias.
    4. Antecedentes de reacciones anafilácticas u otras reacciones graves de hipersensibilidad a CAF o a anticuerpos monoclonales o reacciones graves a su perfusión, que según la opinión del investigador puedan suponer un mayor riesgo de reacción grave a la perfusión.
    5. Tratamiento con alguna de las siguientes terapias antineoplásicas antes de la primera dosis del tratamiento del estudio durante los periodos indicados:
    - <= 2 semanas en el caso de tratamiento con fluoropirimidina.
    - <= 4 semanas en el caso de radioterapia o radiación de campo limitado de carácter paliativo durante <= 2 semanas antes de la primera dosis del tratamiento del estudio.
    - <= 4 semanas o <= 5 vidas medias (el menor de estos valores) en el caso de quimioterapia o terapia biológica (que incluya anticuerpos monoclonales), tratamiento con moléculas pequeñas continuo o intermitente o cualquier otro fármaco en investigación.
    - <= 6 semanas en el caso de fármacos citotóxicos con toxicidades retardadas importantes, como nitrosoureas y mitomicina C.
    - <= 4 semanas en el caso de terapia inmunooncológica, como antagonistas de CTLA-4, PD-1 o PD-L1.
    6. Cardiopatía clínicamente significativa o no controlada como insuficiencia cardíaca congestiva que requiera tratamiento (grado >=2 de la NYHA) o arritmia clínicamente significativa a pesar del tratamiento médico.

    Pueden aplicar otros criterios definidos por protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Phase I: Incidence and severity of dose limiting toxicities (DLTs) during the first 28 days of treatment.
    2. Phase I: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs
    3. Phase I: Frequency of dose interruptions, reductions, and discontinuations
    4. Phase II: Overall Response rate (ORR) per RECIST 1.1
    1. Fase I: Incidencia e intensidad de las toxicidades limitantes de la dosis (DLT) durante los primeros 28 días del tratamiento.
    2. Fase I: Incidencia e intensidad de los acontecimientos adversos (AA) y los acontecimientos adversos graves (AAG), incluidos los cambios en los valores de laboratorio, electrocardiogramas (ECG) y las constantes vitales.
    3. Fase I: Frecuencia de las interrupciones, reducciones y discontinuaciones de las dosis.
    4. Fase II: Tasa de respuesta global (ORR) según RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.: 28 days
    2. and 3.: 9 months
    4.: 17 months
    1.: 28 días
    2. y 3.: 9 meses
    4.: 17 meses
    E.5.2Secondary end point(s)
    1. Phase I and Phase II: PK parameters for total mAb, conjugated active and inactive payload, and unconjugated active payloads (e.g., AUC, Cmax, CL, half-life)
    2. Phase I: Prevalence and incidence of anti-DYP688 antibodies
    3. Phase I: Best Overall Response (BOR)
    4. Phase I: Overall Response Rate (ORR) per RECIST v1.1
    5. Phase II: Duration of response (DoR), progression free survival (PFS) and DCR per RECIST v1.1
    6. Phase II: Overall survival (OS)
    7. Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs
    8. Phase II: Frequency of dose interruptions, reductions, and discontinuations
    PK parameters for total mAb, conjugated active and inactive payload, and unconjugated active payloads (e.g., AUC, Cmax, CL, half-life)
    1. Fase I y fase II: Parámetros de PK como anticuerpo monoclonal (AM) total, carga útil activa e inactiva conjugada y cargas útiles activas no conjugadas (p. ej., AUC, Cmax, CL y vida media).
    2. Fase I: Prevalencia e incidencia de anticuerpos anti-DYP688.
    3. Fase I: Mejor respuesta global (BOR)
    4. Fase I: Tasa de respuesta global (ORR) según RECIST v1.1.
    5. Fase II: Duración de la respuesta (DoR), supervivencia libre de progresión (PFS) y tasa de control de la enfermedad (DCR) según RECIST v1.1.
    6. Fase II: Supervivencia global (OS).
    7. Fase II: Seguridad: incidencia e intensidad de los acontecimientos adversos (AA) y los acontecimientos adversos graves (AAG), incluidos los cambios en los valores de laboratorio, electrocardiogramas (ECG) y las constantes vitales.
    8. Fase II: Tolerabilidad: frecuencia de las interrupciones, reducciones y discontinuaciones de las dosis.
    Parámetros de PK como AM total, carga útil activa e inactiva conjugada y cargas útiles activas no conjugadas (p. ej., AUC, Cmax, CL y vida media).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.: 26 months
    2. and 3.: 9 months
    4. to 8.: 17 months
    1.: 26 meses
    2. y 3.: 9 meses
    4. a 8.: 17 meses
    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 No
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    United States
    France
    Netherlands
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    Norway
    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
    última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 6
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 124
    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 Decision2022-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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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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