Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Primo nello studio umano di M6223

13 aprile 2026 aggiornato da: EMD Serono Research & Development Institute, Inc.

Studio di fase I, primo nell'uomo, in aperto, a dose ascendente multipla per studiare la sicurezza, la tollerabilità, la farmacocinetica, la farmacodinamica e l'attività clinica di M6223, un inibitore di TIGIT, come agente singolo e in combinazione con Bintrafusp Alfa (anti- PDL1/ TGFß Trap) in partecipanti con tumori solidi non resecabili metastatici o localmente avanzati

Lo scopo principale di questo studio è determinare la sicurezza, la tollerabilità, la farmacocinetica (PK), l'immunogenicità e (se osservata) la dose massima tollerata (MTD) di M6223 come singolo agente (Parte 1A) sia per ogni 2 settimane (Q2W ) e il regime ogni 3 settimane (Q3W) e di M6223 combinato con bintrafusp alfa (Parte 1B) per il regime Q2W in partecipanti con tumori solidi non resecabili metastatici o localmente avanzati.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

58

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
      • Toronto, Canada
        • Princess Margaret Cancer Centre
  • Stati Uniti
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, Stati Uniti, 78229
        • NEXT Oncology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • - I partecipanti hanno istologicamente o citologicamente dimostrato tumori maligni localmente avanzati o solidi avanzati che sono refrattari o sono progrediti con il trattamento standard e non hanno altre opzioni terapeutiche note per conferire beneficio clinico
  • Partecipanti con stato delle prestazioni dell'Eastern Cooperative Oncology Group (ECOG PS) da 0 a 1 allo screening
  • - Il partecipante ha un blocco incluso in paraffina fissato in formalina contenente tessuto tumorale o un minimo di 15 (preferibilmente 25) vetrini tumorali non colorati adatti per la colorazione basata sull'immunoistochimica dell'espressione proteica
  • Partecipanti con un'aspettativa di vita di almeno 12 settimane
  • Partecipanti con malattia misurabile secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1)
  • Adeguata funzionalità ematologica, epatica e renale come definito nel protocollo
  • Possono essere applicati altri criteri di inclusione definiti dal protocollo

Criteri di esclusione:

  • Partecipanti con tossicità persistente correlata alla terapia precedente Grado superiore a (>) 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Versione 5.0, tuttavia, alopecia, neuropatia sensoriale Grado inferiore o uguale a (<=) 2, o altro Grado <= 2 non immuno-correlato che non costituisca un rischio per la sicurezza
  • - Partecipanti con precedente trapianto di organi, incluso trapianto allogenico di cellule staminali
  • Partecipanti con precedente tossicità correlata a un inibitore del checkpoint immunitario Grado maggiore di uguale a (>=) 3 NCI-CTCAE Versione 5.0 a meno che non sia stato risolto al Grado <= 1 prima dell'inclusione nello studio
  • - Partecipanti con attuali anomalie significative della conduzione cardiaca, incluso il prolungamento dell'intervallo QT corretto (QTcF, corretto con la formula di Fridericia) di> 450 millisecondi (ms) su triplicato ECG a 12 derivazioni o funzione cardiovascolare compromessa, tachicardia ventricolare, ipokaliemia o storia di parossistica atriale fibrillazione, grave aritmia cardiaca e storia familiare di morte improvvisa o sindrome del QT lungo
  • Una storia di malattia vascolare, cardiovascolare o cerebrovascolare come, incidente vascolare cerebrale/ictus (meno di [<] 6 mesi prima dell'arruolamento), infarto del miocardio (<6 mesi prima dell'arruolamento), angina instabile, insufficienza cardiaca congestizia (New York Heart Classificazione di associazione Classe >= II), trombosi venosa profonda (<3 mesi prima dell'arruolamento) o trombosi/embolia polmonare (<3 mesi prima dell'arruolamento)
  • Possono essere applicati altri criteri di esclusione definiti dal protocollo

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Parte 1A: M6223 Monoterapia
Droga: M6223
Participants received an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) or every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Droga: M6223
Participants received an IV infusion of M6223 at escalated doses Q2W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression.
Sperimentale: Parte 1B: M6223 + Bintrafusp alfa
Droga: M6223
Participants received an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) or every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Droga: M6223
Participants received an IV infusion of M6223 at escalated doses Q2W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression.
Droga: Bintrafusp alfa
Participants received an IV infusion of bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) until confirmed disease progression.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1A and 1B: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0
Lasso di tempo: Day 1 to Day 28
A DLT is defined as any Grade ≥ 3 non-hematologic AE or any Grade ≥ 4 hematologic AE according to the NCI-CTCAE, occurring during the DLT observation period (28 days from first administration of study intervention) that is not clearly related to the underlying disease or any previous or concomitant medication, concomitant disease or unrelated illness. A DLT must be confirmed by the Safety Monitoring Committee. DLT is considered if the following related AEs occur: • Grade ≥ 3 neutropenia with clinical signs/symptoms (e.g., febrile neutropenia). • Grade ≥ 3 thrombocytopenia with medically concerning bleeding. • A study intervention-related treatment-emergent AE that in the opinion of the SMC is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk. • Grade ≥ 3 hematological AE with symptoms that require growth factor support or transfusion to prevent further damage to the participant.
Day 1 to Day 28
Part 1A and 1B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
Lasso di tempo: Approximately 2 years 11 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events that started or worsened after first dose of study intervention until 30 days after last dose. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With TEAES With Severity of Grade Greater or Equal to 3 and TEAEs Leading to Deaths
Lasso di tempo: Approximately 2 years 11 months
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of the study intervention, regardless of causality. A serious AE results in death, is life-threatening, requires/prolongs hospitalization, causes disability/incapacity, leads to a congenital anomaly/birth defect, or is otherwise medically significant. Treatment-emergent adverse events (TEAEs) are those that begin or worsen after the first dose through 30 days post-treatment, and include both serious and non-serious events. Treatment-related TEAEs are those reasonably related to the study intervention. Severity is graded per CTCAE v24.1: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe/medically significant), Grade 4 (life-threatening/disabling), Grade 5 (death related to AE).
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values
Lasso di tempo: Approximately 2 years 11 months
Number of participants with clinically meaningful change from baseline in laboratory parameters were reported. Clinically meaningful abnormalities (identified as laboratory values having CTCAE grades >= 3). Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)
Lasso di tempo: Approximately 2 years 11 months
Number of participants with clinically significant change from baseline in ECG parameters were reported. Clinical Significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
Lasso di tempo: Approximately 2 years 11 months
Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical Relevance was decided by the investigator. Number of participants with clinically relevant change from baseline in vital signs were reported. Clinical relevance was defined as increase more than equal to (>=) 3° temperature, >40 beats heart rate increase, >40 mmHG increase in systolic or diastolic blood pressure, >10 breaths in respiratory rate increase.
Approximately 2 years 11 months
Part 1A and 1B: Number of Participants With Worsened Post Baseline Shift in Eastern Cooperative Oncology Group Performance Status
Lasso di tempo: Approximately 2 years 11 months
The number of participants who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.
Approximately 2 years 11 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M6223
Lasso di tempo: Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule. The full form of unit of measure h*mcg/mL is hours · micrograms per milliliter.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of M6223
Lasso di tempo: Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Area Under Serum Concentration-Time Curve Over a Dosing Interval From Time Zero to Tau (AUC-tau) of M6223
Lasso di tempo: Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycle 1 (Cycle is of 21 days in Q3W regimen)
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycle 1 (Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Maximum Observed Serum Concentration (Cmax) of M6223
Lasso di tempo: Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of M6223
Lasso di tempo: Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Ctrough is the concentration prior to study drug administration.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1A and Part 1B: Time to Reach Maximum Serum Concentration (Tmax) of M6223
Lasso di tempo: Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
Time taken to reach maximum concentration of M66223 after admistration is reported.
Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
Part 1A and Part 1B: Apparent Terminal Half-Life (t1/2) of M6223
Lasso di tempo: Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
Part 1A and Part 1B: Elimination Rate Constant (Lambda z) of M6223
Lasso di tempo: Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
Part 1B: Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa
Lasso di tempo: Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp Alfa
Lasso di tempo: Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Ctrough is the concentration prior to study drug administration.
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
Part IA and 1B: Number of Participants With Positive Antidrug Antibody (ADA) Assays
Lasso di tempo: Pre-dose of Day 1 Cycle 1 (Each Cycle is of 14 days in Q2W regimen and 21 days in Q3W regimen) up to end of safety follow-up visit ( approximately 2 years 11 months)
Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.
Pre-dose of Day 1 Cycle 1 (Each Cycle is of 14 days in Q2W regimen and 21 days in Q3W regimen) up to end of safety follow-up visit ( approximately 2 years 11 months)
Part 1A and IB: Best Overall Response According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Lasso di tempo: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
The ORR is defined as the number of participants with a documented BOR (complete response (CR) or partial response (PR)) by the investigator during treatment with avelumab plus axitinib as firstline therapy. The BOR is defined as the best tumor response recorded during the observation period. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD], not Evaluable [NE]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
Part 1A and 1B: Duration of Response (DOR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Lasso di tempo: From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
Part 1A and 1B: Time to Tumor Response (TTR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Lasso di tempo: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
TTR was defined for participants who achieved objective response as time from first study drug administration to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as a score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
Part 1A and 1B: Disease Control According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Lasso di tempo: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
Disease control rate was defined as percentage of participants with disease control. Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD). CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than <mediastinum but <=liver) with or without a residual mass on Positron Emission Tomography 5-Point Scale, for lymph nodes and extra lymphatic sites; no new lesions; no evidence of fluorodeoxyglucose -avid disease in bone marrow. PR: >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in Sum of the Products of Diameters of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
Part 1A and 1B: Progression-free Survival Time According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
Lasso di tempo: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
Progression Free Survival (PFS) time is defined as the time from start date of treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first. The tumor response will be determined according to RECIST 1.1 and assessed by the investigator.
From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
Part 1A and 1B: Overall Survival
Lasso di tempo: From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)
Overall survival was defined as the time (in months) from first study drug administration to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaboratori

Merck KGaA, Darmstadt, Germany

Investigatori

  • Direttore dello studio: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 luglio 2020

Completamento primario (Effettivo)

23 giugno 2023

Completamento dello studio (Effettivo)

23 giugno 2023

Date di iscrizione allo studio

Primo inviato

30 giugno 2020

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2020

Primo Inserito (Effettivo)

7 luglio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MS201430_0001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Ci impegniamo a migliorare la salute pubblica attraverso la condivisione responsabile dei dati delle sperimentazioni cliniche. A seguito dell'approvazione di un nuovo prodotto o di una nuova indicazione per un prodotto approvato sia negli Stati Uniti che nell'Unione Europea, lo sponsor dello studio e/o le sue società affiliate condivideranno i protocolli dello studio, i dati anonimi del paziente e i dati a livello di studio e i rapporti degli studi clinici redatti con ricercatori scientifici e medici qualificati, su richiesta, se necessario per condurre ricerche legittime. Ulteriori informazioni su come richiedere i dati sono disponibili sul nostro sito web bit.ly/IPD21

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Tumori solidi metastatici

Prove cliniche su M6223

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Cote d'Ivoire

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi