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    Summary
    EudraCT Number:2021-002181-41
    Sponsor's Protocol Code Number:ACT16902
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-002181-41
    A.3Full title of the trial
    A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with advanced and metastatic gastrointestinal cancer (Pegasus Gastrointestinal 203)
    Studio di fase 2, non randomizzato, in aperto, multi-coorte, multicentrico per valutare il beneficio clinico di SAR444245 (THOR-707) in combinazione con altre terapie antitumorali per il trattamento di pazienti con tumori gastrointestinali avanzati e metastatici (Pegasus Gastrointestinal 203)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of SAR444245 combined with other anticancer therapies for the treatment of participants with gastrointestinal cancer (Master protocol)
    Studio di SAR444245 in combinazione con altre terapie antitumorali per il trattamento di pazienti con tumori gastrointestinali (protocollo principale)
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    A.4.1Sponsor's protocol code numberACT16902
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1251-4981
    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 SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.r.l.
    B.5.2Functional name of contact pointContact Point
    B.5.3 Address:
    B.5.3.1Street AddressViale Luigi Bodio 37/B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800536389
    B.5.5Fax number000000
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 Yes
    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 nameTocilizumab
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate for 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 INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 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 Yes
    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.3.1Product nameErbitux
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 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
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V. - numero MA: EU/1/15/1024/002
    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.3.1Product nameKeytruda
    D.3.2Product code [NA]
    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.3.9.2Current sponsor codeNA
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 nameNA
    D.3.2Product code [SAR444245]
    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.3.9.1CAS number 2573074-47-0
    D.3.9.2Current sponsor codeSAR444245
    D.3.9.4EV Substance CodeSUB219171
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Advanced and metastatic gastrointestinal cancer
    Tumori gastrointestinali avanzati e metastatici
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal cancer
    Tumori gastrointestinali
    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 PT
    E.1.2Classification code 10061534
    E.1.2Term Oesophageal 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 10030137
    E.1.2Term Oesophageal adenocarcinoma
    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 10017758
    E.1.2Term Gastric 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 10073071
    E.1.2Term Hepatocellular 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 10061451
    E.1.2Term Colorectal 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the antitumor activity of SAR444245 in combination with other anticancer therapies
    Determinare l’attività antitumorale di SAR444245 in combinazione con altre terapie antitumorali
    E.2.2Secondary objectives of the trial
    - To assess the safety of SAR444245 when combined with other anticancer therapies
    - To assess other indicators of antitumor activity
    - To assess the pharmacokinetics of SAR444245 when given in combination with other anticancer therapies
    - To assess the immunogenicity of SAR444245
    - Only for sub study 04 – Cohort D2: To assess active concentrations of cetuximab when given in combination with SAR444245
    - Valutare la sicurezza di SAR444245 in combinazione con altre terapie antitumorali
    - Valutare altri indicatori di attività antitumorale
    - Valutare la farmacocinetica (PK) di SAR444245 in combinazione con altre terapie antitumorali
    - Valutare l’immunogenicità di SAR444245
    - Solo per il sottostudio 04 – Coorte D2: Valutare le concentrazioni attive di cetuximab quando somministrato in combinazione con SAR444245
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: - Sub-study01: A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with pembrolizumab for the treatment of participants with advanced and metastatic esophageal squamous cell carcinoma. Protocol number: ACT16902-S01, version 01 dated on 2021-08-30
    - Sub-study02: A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with pembrolizumab for the treatment of participants with advanced and metastatic gastric cancer or gastro-esophageal
    junction adenocarcinoma. Protocol number: ACT16902-S02, version 01 dated on 2021-08-30
    - Sub-study03: A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with pembrolizumab for the treatment of participants with advanced and metastatic hepatocellular carcinoma. Protocol number: ACT16902-S03, version 01 dated on 2021-08-30
    - Sub-study04: A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with pembrolizumab or cetuximab for the treatment of participants with advanced and metastatic colorectal cancer. Protocol number: ACT16902-S04, version 01 dated on 2021-08-30
    For related objectives, refer to E.2.1 and E.2.2.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: - Sottostudio01: Studio di fase 2, non randomizzato, in aperto, multi-coorte, multicentrico per valutare il beneficio clinico di SAR444245 (THOR-707) in combinazione con pembrolizumab per il trattamento di pazienti con carcinoma esofageo a cellule squamose avanzato e metastatico. Numero di protocollo: ACT16902-S01, versione 01 del 30-08-2021
    - Sottostudio02: Studio di fase 2, non randomizzato, in aperto, multi-coorte, multicentrico per valutare il beneficio clinico di SAR444245 (THOR-707) in combinazione con pembrolizumab per il trattamento di pazienti con tumore gastrico o adenocarcinoma della giunzione gastro-esofagea avanzato e metastatico. Numero di protocollo: ACT16902-S02, versione 01 del 30-08-2021
    - Sottostudio03: Studio di fase 2, non randomizzato, in aperto, multi-coorte, multicentrico per valutare il beneficio clinico di SAR444245 (THOR-707) in combinazione con pembrolizumab per il trattamento di pazienti con carcinoma epatocellulare avanzato e metastatico. Numero di protocollo: ACT16902-S03 versione 01 del 30-08-2021
    - Sottostudio04: Studio di fase 2, non randomizzato, in aperto, multi-coorte, multicentrico per valutare il beneficio clinico di SAR444245 (THOR-707) in combinazione con pembrolizumab o cetuximab per il trattamento di pazienti con tumore colorettale avanzato e metastatico. Numero di protocollo: ACT16902-S04 versione 01 del 30-08-2021
    Per i relativi obiettivi, fare riferimento a E.2.1 e E.2.2.
    E.3Principal inclusion criteria
    Participant must be >=18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
    Participants with:
    - Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype
    - Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ.
    - Sub-study03: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic HCC, or clinically by AASLD criteria in cirrhotic patients.
    - Sub-study04: Histologically or cytologically confirmed diagnosis of advanced unresectable or mCRC. Only patients with non-MSI-H disease are eligible.
    Participants (all sub-studies) must have at least one measurable lesion
    Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01, sub-study02 and sub-study04. On-treatment biopsy for at least 20 participants in sub-study04. On-treatment biopsies are otherwise optional per Investigator’s discretion for the other cohorts.

    Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
    - to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment
    - and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.

    Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.

    Capable of giving signed informed consent
    Il/La paziente deve avere >=18 anni d’età (o aver raggiunto la maggiore età legale del Paese, se >18 anni) al momento della firma del consenso informato.
    - Sottostudio01: Diagnosi istologicamente o citologicamente confermata di carcinoma esofageo avanzato non resecabile o metastatico del sottotipo carcinoma a cellule squamose.
    - Sottostudio02: Diagnosi confermata istologicamente o citologicamente di GC o GGE Siewert di tipo 2 e 3 avanzato non resecabile o metastatico
    - Sottostudio03: Diagnosi confermata istologicamente o citologicamente di HCC avanzato non resecabile o metastatico o clinicamente in base ai criteri AASLD nei/nelle pazienti cirrotici/che
    - Sottostudio04: Diagnosi istologicamente o citologicamente confermata di tumore colorettale Avanzato non resecabile o metastatico. Sono eleggibili solo i/le pazienti con malattia non-MSI-H.
    I pazienti (tutti i sottostudi) devono avere almeno una lesione misurabile.
    Biopsia obbligatoria al basale per i primi 20 pazienti arruolati nel sottostudio01, sottostudio02 e sottostudio04. Biopsia durante il trattamento per almeno 20 pazienti arruolati nel sottostudio04. Per le altre coorti le biopsie durante il trattamento sono altrimenti facoltative a discrezione dello sperimentatore.
    - Una paziente di sesso femminile è idonea a partecipare se non è in gravidanza o in allattamento, non è una donna in età fertile (WOCBP - woman of childbearing potential) o se è una WOCBP che accetta:
    - Di utilizzare un metodo contraccettivo approvato e sottoporsi a regolari test di gravidanza prima del trattamento e per almeno 180 giorni dopo l'interruzione del trattamento in studio
    - e ad astenersi dal donare o crioconservare gli ovuli per 180 giorni dopo l'interruzione del trattamento in studio.
    - I maschi possono partecipare se accettano di astenersi dal donare o crioconservare lo sperma e si astengono da rapporti eterosessuali OPPURE utilizzano contraccettivi approvati durante il trattamento in studio e per almeno 210 giorni dopo l'interruzione del trattamento in studio.
    - In grado di fornire un consenso informato scritto
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Eastern Cooperative Oncology Group (ECOG) performance status of >=2
    - Poor organ function
    - Active brain metastases or leptomeningeal disease.
    - History of allogenic or solid organ transplant.
    - Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery within 28 days prior to first IMP administration
    - Comorbidity requiring corticosteroid therapy
    - Antibiotic use (excluding topical antibiotics) <=14 days prior to first dose of IMP
    - Severe or unstable cardiac condition within 6 months prior to starting study treatment
    - Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
    - Participants with baseline SpO2 <=92% (without oxygen therapy).
    - Participant has received prior IL2-based anticancer treatment.
    - Participants on sub-study02 cohort B1 and B2 or sub-study 04 – cohort D1 with prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
    - Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
    I pazienti sono esclusi dallo studio se presentano uno qualsiasi dei seguenti criteri:
    - Performance Status >=2 in base all’indice ECOG (Eastern Cooperative Oncology Group).
    - Scarsa funzionalità degli organi
    - Metastasi cerebrali o metastasi leptomeningee attive
    - Anamnesi di trapianto allogenico di tessuto/organo solido
    - Ultima somministrazione di terapia antitumorale precedente o di qualsiasi trattamento sperimentale entro 28 giorni o meno di 5 volte l’emivita, a seconda di quale sia il periodo più breve; intervento chirurgico maggiore entro 28 giorni precedenti la prima somministrazione dell’IMP.
    - Comorbidità che richiede terapia con corticosteroidi
    - Uso di antibiotici (esclusi antibiotici topici) <=14 giorni prima della prima dose dell’IMP
    - Condizione cardiaca grave o instabile nei 6 mesi precedenti l’inizio del trattamento dello studio
    - Malattia autoimmune attiva, nota o sospetta, che abbia richiesto un trattamento sistemico negli ultimi 2 anni
    - Pazienti con SpO2 basale <=92% (senza ossigenoterapia).
    - Pazienti che hanno ricevuto un precedente trattamento antitumorale a base di IL2.
    - Pazienti del sottostudio02 coorte B1 e B2 o del sottostudio 04 – coorte D1 con precedente trattamento con un agente che blocca la via PD-1/PD-L1.
    -Ricezione di un vaccino con virus vivi nei 28 giorni precedenti l’inizio previsto del trattamento. I vaccini antinfluenzali stagionali che non contengono virus vivi sono consentiti.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR)
    Tasso di risposta obiettiva (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to the date of first documentation of progression, assessed approximatively up to 9 months after the first dose
    dal baseline fino alla data della prima documentazione di progressione, valutata approssimativamente fino a 9 mesi dopo la prima dose
    E.5.2Secondary end point(s)
    1- Assessment of SAR444245 safety profile when combined with other anti-cancer therapies
    2- Time to response
    3- Duration of response
    4- Clinical benefit rate
    5- Progression-free survival
    6- Concentrations of SAR444245
    7- Incidence of anti-drug antibodies (ADAs) against SAR444245
    8- Ctrough of infusion of cetuximab
    9- Cend of infusion of cetuximab
    1- Valutazione del profilo di sicurezza SAR444245 in combinazione con altre terapie antitumorali
    2- Tempo alla risposta
    3- Durata della risposta
    4- Tasso di beneficio clinico
    5- Sopravvivenza libera da progressione
    6- Concentrazioni di SAR444245
    7- Incidenza di anticorpi anti-farmaco (ADA) contro SAR444245
    8- Ca valle dell'infusione di cetuximab
    9- Ca fine dell'infusione di cetuximab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1:SAE:from 1st IMP dose up to 90 days after the last dose of IMP AE/TEAE:from 1st IMP dose up to 30 days after the last dose of IMP
    2to5:Baseline to the date of first documentation of progression, assessed approximatively up to 18 months after the last patient-in
    6:At Day1, 2, 3 of Cycle1 and Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21days), maximum is up to approximately 24 months
    7:At Day 1 and 15 of Cycle1, at Day 1 of Cycle 2-4-7-10 + every 5th cycle and 30 days after last IMP administration, maximum is up to approximately 24 months
    8:Day1 of Cycle1-2-4-7-10 + every 5th cycle and 30 days after last IMP administration, maximum is up to approximately 24 months
    9:Day1 of Cycle1-2-4-7-10 + every 5th cycle, maximum is up to approximately 24 months
    1: SAE:dalla 1a dose di IMP fino a 90 gg dopo l'ultima dose di IMP AE/TEAE:dalla 1a dose di IMP fino a 30 gg dopo l'ultima dose di IMP
    da 2 a 5: dal baseline fino alla data della prima documentazione di progressione, valutata approssimativamente fino a 18 mesi dopo l'ultimo paziente-incluso
    6: Al gg 1, 2, 3 del ciclo 1 e al gg 1 del ciclo 2-4-7-10 + ogni 5 cicli (ogni ciclo è di 21 gg), il massimo è fino a circa 24 mesi
    7: Al gg 1 e 15 del ciclo1, al gg 1 del ciclo 2-4-7-10 + ogni 5 cicli e 30 gg dopo l'ultima somministrazione di IMP, il massimo è fino a circa 24 mesi
    8: gg 1 del ciclo1-2-4-7-10 + ogni 5 cicli e 30 gg dopo l'ultima somministrazione di IMP, il massimo è fino a circa 24 mesi
    9: gg 1 del ciclo1-2-4-7-10 + ogni 5 cicli, il massimo è fino a circa 24 mesi
    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 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) No
    E.7.1.1First administration to humans No
    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 No
    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.8.1.7.1Other trial design description
    Studio in aperto
    open label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    NA
    NA
    E.8.2.4Number of treatment arms in the trial7
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    China
    Korea, Republic of
    Russian Federation
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    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
    LVLS
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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 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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 210
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 350
    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
    nessuna
    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 Decision2021-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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