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Zuerst in der Humanstudie von M6223

13. April 2026 aktualisiert von: EMD Serono Research & Development Institute, Inc.

Open-Label-Studie der Phase I, First-in-Human, Multiple Ascending Dose-Studie zur Untersuchung der Sicherheit, Verträglichkeit, Pharmakokinetik, Pharmakodynamik und klinischen Aktivität von M6223, einem Inhibitor von TIGIT, als Einzelwirkstoff und in Kombination mit Bintrafusp Alfa (Anti- PDL1/ TGFß Trap) bei Teilnehmern mit metastasierten oder lokal fortgeschrittenen soliden, nicht resezierbaren Tumoren

Der Hauptzweck dieser Studie besteht darin, die Sicherheit, Verträglichkeit, Pharmakokinetik (PK), Immunogenität und (falls beobachtet) die maximal tolerierte Dosis (MTD) von M6223 als Einzelwirkstoff (Teil 1A) sowohl alle 2 Wochen (Q2W )-Schema und das alle 3 Wochen (Q3W)-Schema und von M6223 in Kombination mit Bintrafusp alfa (Teil 1B) für das Q2W-Schema bei Teilnehmern mit metastasierten oder lokal fortgeschrittenen soliden, nicht resezierbaren Tumoren.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

58

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Die Teilnehmer haben histologisch oder zytologisch nachgewiesene lokal fortgeschrittene oder fortgeschrittene solide Malignome, die gegenüber der Standardbehandlung refraktär oder fortgeschritten sind und keine anderen Behandlungsoptionen haben, von denen bekannt ist, dass sie einen klinischen Nutzen bringen
  • Teilnehmer mit einem Eastern Cooperative Oncology Group Performance Status (ECOG PS) von 0 bis 1 beim Screening
  • Der Teilnehmer hat einen formalinfixierten, in Paraffin eingebetteten Block mit Tumorgewebe oder mindestens 15 (vorzugsweise 25) ungefärbte Tumorobjektträger, die für die immunhistochemische Färbung der Proteinexpression geeignet sind
  • Teilnehmer mit einer Lebenserwartung von mindestens 12 Wochen
  • Teilnehmer mit messbarer Erkrankung gemäß Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  • Angemessene hämatologische, hepatische und renale Funktion wie im Protokoll definiert
  • Andere protokolldefinierte Einschlusskriterien können gelten

Ausschlusskriterien:

  • Teilnehmer mit anhaltender Toxizität im Zusammenhang mit einer vorherigen Therapie Grad größer als (>) 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, jedoch Alopezie, sensorische Neuropathie Grad kleiner oder gleich (<=) 2, oder anderer nicht immunbezogener Grad <= 2, der kein Sicherheitsrisiko darstellt
  • Teilnehmer mit vorheriger Organtransplantation, einschließlich allogener Stammzelltransplantation
  • Teilnehmer mit früherer Toxizität im Zusammenhang mit einem Immun-Checkpoint-Inhibitor Grad größer als gleich (>=) 3 NCI-CTCAE Version 5.0, es sei denn, es wurde vor Studieneinschluss auf Grad <= 1 entschieden
  • Teilnehmer mit aktuellen signifikanten Herzleitungsstörungen, einschließlich korrigiertem QT-Intervall (QTcF, korrigiert mit Fridericia-Formel), Verlängerung von > 450 Millisekunden (ms) bei dreifachem 12-Kanal-EKG oder eingeschränkter kardiovaskulärer Funktion, ventrikulärer Tachykardie, Hypokaliämie oder paroxysmaler atrialer Vorgeschichte in der Vorgeschichte Vorhofflimmern, schwere Herzrhythmusstörungen und plötzlicher Tod in der Familienanamnese oder Long-QT-Syndrom
  • Eine Vorgeschichte von vaskulären, kardiovaskulären oder zerebrovaskulären Erkrankungen wie zerebraler vaskulärer Unfall/Schlaganfall (weniger als [<] 6 Monate vor der Einschreibung), Myokardinfarkt (< 6 Monate vor der Einschreibung), instabile Angina pectoris, dekompensierte Herzinsuffizienz (New York Heart Assoziationsklassifikation Klasse >= II), tiefe Venenthrombose (< 3 Monate vor Aufnahme) oder Lungenthrombose/-embolie (< 3 Monate vor Aufnahme)
  • Andere protokolldefinierte Ausschlusskriterien können gelten

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Teil 1A: M6223 Monotherapie
Arzneimittel: 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.
Arzneimittel: 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.
Experimental: Part1B: M6223 + Bintrafusp alfa
Arzneimittel: 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.
Arzneimittel: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

EMD Serono Research & Development Institute, Inc.

Mitarbeiter

Merck KGaA, Darmstadt, Germany

Ermittler

  • Studienleiter: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. Juli 2020

Primärer Abschluss (Tatsächlich)

23. Juni 2023

Studienabschluss (Tatsächlich)

23. Juni 2023

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juni 2020

Zuerst gepostet (Tatsächlich)

7. Juli 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MS201430_0001

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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