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Первое исследование M6223 на людях

13 апреля 2026 г. обновлено: EMD Serono Research & Development Institute, Inc.

Фаза I, первое открытое исследование на людях с множественными возрастающими дозами для изучения безопасности, переносимости, фармакокинетики, фармакодинамики и клинической активности M6223, ингибитора TIGIT, в качестве отдельного агента и в комбинации с бинтрафуспом альфа (анти- Ловушка PDL1/TGFß) у участников с метастатическими или местнораспространенными солидными нерезектабельными опухолями

Основная цель этого исследования - определить безопасность, переносимость, фармакокинетику (ФК), иммуногенность и (если наблюдается) максимально переносимую дозу (MTD) M6223 в качестве монотерапии (часть 1A) как каждые 2 недели (Q2W ) и режим каждые 3 недели (Q3W), а также M6223 в сочетании с бинтрафуспом альфа (часть 1B) для режима Q2W у участников с метастатическими или местно-распространенными солидными неоперабельными опухолями.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

58

Фаза

  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • Участники имеют гистологически или цитологически подтвержденные местно-распространенные или распространенные солидные злокачественные новообразования, которые рефрактерны или прогрессировали при стандартном лечении и не имеют других вариантов лечения, которые, как известно, приносят клиническую пользу.
  • Участники со статусом эффективности Восточной кооперативной онкологической группы (ECOG PS) от 0 до 1 при скрининге
  • У участника есть фиксированный формалином залитый в парафин блок, содержащий опухолевые ткани, или как минимум 15 (предпочтительно 25) неокрашенных предметных стекол с опухолями, подходящих для иммуногистохимического окрашивания экспрессии белка.
  • Участники с ожидаемой продолжительностью жизни не менее 12 недель
  • Участники с измеримым заболеванием в соответствии с Критериями оценки ответа при солидных опухолях версии 1.1 (RECIST 1.1)
  • Адекватная гематологическая, печеночная и почечная функция, как определено в протоколе
  • Могут применяться другие критерии включения, определенные протоколом.

Критерий исключения:

  • Участники с сохраняющейся токсичностью, связанной с предшествующей терапией. Степень выше (>) 1. Общие критерии терминологии Национального института рака для нежелательных явлений (NCI-CTCAE), версия 5.0, однако алопеция, сенсорная невропатия. Степень ниже или равна (<=) 2, или другие не связанные с иммунитетом степени <= 2, не представляющие риска для безопасности
  • Участники с предшествующей трансплантацией органов, включая аллогенную трансплантацию стволовых клеток
  • Участники с предшествующей токсичностью, связанной с ингибитором иммунных контрольных точек. Степень выше, чем равна (>=) 3 NCI-CTCAE версии 5.0, если до включения в исследование не было принято решение о степени <= 1.
  • Участники с текущими значительными нарушениями сердечной проводимости, включая скорректированный интервал QT (QTcF, скорректированный с помощью формулы Fridericia), удлинение > 450 миллисекунд (мс) на трехкратной ЭКГ в 12 отведениях или нарушение сердечно-сосудистой функции, желудочковую тахикардию, гипокалиемию или пароксизм предсердий в анамнезе фибрилляция, серьезная сердечная аритмия и семейный анамнез внезапной смерти или синдром удлиненного интервала QT
  • Сосудистые, сердечно-сосудистые или цереброваскулярные заболевания в анамнезе, такие как инсульт/инсульт (менее [<] 6 месяцев до включения в исследование), инфаркт миокарда (< 6 месяцев до включения в исследование), нестабильная стенокардия, застойная сердечная недостаточность (New York Heart Класс классификации ассоциации >= II), тромбоз глубоких вен (< 3 месяцев до включения в исследование) или тромбоз/эмболию легких (< 3 месяцев до включения в исследование)
  • Могут применяться другие критерии исключения, определенные протоколом.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Часть 1A: Монотерапия M6223
Лекарство: 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.
Лекарство: 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.
Экспериментальный: Часть 1B: M6223 + бинтрафусп альфа
Лекарство: 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.
Лекарство: 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.
Лекарство: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

EMD Serono Research & Development Institute, Inc.

Соавторы

Merck KGaA, Darmstadt, Germany

Следователи

  • Директор по исследованиям: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

10 июля 2020 г.

Первичное завершение (Действительный)

23 июня 2023 г.

Завершение исследования (Действительный)

23 июня 2023 г.

Даты регистрации исследования

Первый отправленный

30 июня 2020 г.

Впервые представлено, что соответствует критериям контроля качества

30 июня 2020 г.

Первый опубликованный (Действительный)

7 июля 2020 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

13 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • MS201430_0001

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Мы стремимся укреплять общественное здравоохранение посредством ответственного обмена данными клинических испытаний. После утверждения нового продукта или нового показания для одобренного продукта как в США, так и в Европейском союзе спонсор исследования и/или его аффилированные компании будут делиться протоколами исследования, анонимными данными пациентов и данными уровня исследования, а также отредактированными отчетами о клинических исследованиях. с квалифицированными научными и медицинскими исследователями, по запросу, если это необходимо для проведения законных исследований. Дополнительную информацию о том, как запросить данные, можно найти на нашем веб-сайте bit.ly/IPD21.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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