M6223에 대한 인체 연구 최초
2026년 4월 13일 업데이트: EMD Serono Research & Development Institute, Inc.
TIGIT의 억제제인 M6223의 안전성, 내약성, 약동학, 약력학 및 임상 활성을 단일 제제로 그리고 Bintrafusp Alfa(Anti- PDL1/ TGFß 트랩) 전이성 또는 국소적으로 진행된 절제 불가능한 고형 종양이 있는 참가자
이 연구의 주요 목적은 2주마다(Q2W) 두 가지 모두에 대해 단일 제제(파트 1A)로서 M6223의 안전성, 내약성, 약동학(PK), 면역원성 및 (관찰된 경우) 최대 허용 용량(MTD)을 결정하는 것입니다. ) 요법 및 매 3주(Q3W) 요법 및 빈트라푸스프 알파(파트 1B)와 병용한 M6223의 전이성 또는 국소 진행성 절제 불가능한 고형 종양이 있는 참가자의 Q2W 요법에 대해.
연구 개요
연구 유형
중재적
등록 (실제)
58
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 참가자는 조직학적 또는 세포학적으로 입증된 국소 진행성 또는 진행성 고형 악성 종양을 가지고 있으며 표준 치료에 불응하거나 진행되었으며 임상적 이점을 부여하는 것으로 알려진 다른 치료 옵션이 없습니다.
- 스크리닝 시 ECOG PS(Eastern Cooperative Oncology Group Performance Status)가 0에서 1인 참가자
- 참가자는 종양 조직을 포함하는 포르말린 고정 파라핀 포매 블록 또는 단백질 발현의 면역조직화학 기반 염색에 적합한 최소 15개(바람직하게는 25개)의 염색되지 않은 종양 슬라이드를 가지고 있습니다.
- 기대 수명이 12주 이상인 참여자
- 고형 종양 버전 1.1(RECIST 1.1)의 반응 평가 기준에 따라 측정 가능한 질병이 있는 참가자
- 프로토콜에 정의된 적절한 혈액학적, 간 및 신장 기능
- 다른 프로토콜 정의 포함 기준이 적용될 수 있습니다.
제외 기준:
- 이전 요법과 관련된 지속적인 독성이 있는 참가자 등급이 (>) 1 이상인 경우 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 버전 5.0, 단, 탈모증, 감각 신경병증 등급이 2 이하(<=)인 경우, 또는 안전 위험을 구성하지 않는 기타 비 면역 관련 등급 <= 2
- 동종이계 줄기 세포 이식을 포함한 이전 장기 이식을 받은 참가자
- 이전에 면역 체크포인트 억제제와 관련된 독성이 있는 참가자 연구 포함 전에 등급 <= 1로 해결되지 않는 한(>=) 3 NCI-CTCAE 버전 5.0 이상 등급
- 수정된 QT 간격(QTcF, Fridericia 공식으로 수정됨)을 포함하여 현재 심각한 심장 전도 이상이 있는 참가자 3중 12-유도 ECG에서 > 450밀리초(ms) 연장 또는 심혈관 기능 장애, 심실 빈맥, 저칼륨혈증 또는 발작성 심방 병력 세동, 심각한 심장 부정맥 및 돌연사의 가족력 또는 긴 QT 증후군
- 뇌혈관 사고/뇌졸중(등록 전 6개월 미만 [<]), 심근 경색증(등록 전 미만 6개월), 불안정 협심증, 울혈성 심부전(뉴욕 심장 협회 분류 클래스 >= II), 심부 정맥 혈전증(등록 전 < 3개월) 또는 폐 혈전증/색전증(등록 전 < 3개월)
- 다른 프로토콜 정의 제외 기준이 적용될 수 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 파트 1A: M6223 단독 요법
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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.
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.
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실험적: Part1B: M6223 + Bintrafusp 알파
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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.
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.
Participants received an IV infusion of bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) until confirmed disease progression.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Day 1 to Day 28
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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.
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Day 1 to Day 28
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Part 1A and 1B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
기간: Approximately 2 years 11 months
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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.
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Approximately 2 years 11 months
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Part 1A and 1B: Number of Participants With TEAES With Severity of Grade Greater or Equal to 3 and TEAEs Leading to Deaths
기간: Approximately 2 years 11 months
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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).
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Approximately 2 years 11 months
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Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values
기간: Approximately 2 years 11 months
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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.
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Approximately 2 years 11 months
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Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)
기간: Approximately 2 years 11 months
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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.
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Approximately 2 years 11 months
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Part 1A and 1B: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
기간: Approximately 2 years 11 months
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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.
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Approximately 2 years 11 months
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Part 1A and 1B: Number of Participants With Worsened Post Baseline Shift in Eastern Cooperative Oncology Group Performance Status
기간: Approximately 2 years 11 months
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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.
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Approximately 2 years 11 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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)
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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.
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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)
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Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of M6223
기간: 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)
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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.
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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)
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Part 1A and Part 1B: Area Under Serum Concentration-Time Curve Over a Dosing Interval From Time Zero to Tau (AUC-tau) of M6223
기간: 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)
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Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval.
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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)
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Part 1A and Part 1B: Maximum Observed Serum Concentration (Cmax) of M6223
기간: 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)
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Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
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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)
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Part 1A and Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of M6223
기간: 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)
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Ctrough is the concentration prior to study drug administration.
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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)
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Part 1A and Part 1B: Time to Reach Maximum Serum Concentration (Tmax) of M6223
기간: 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)
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Time taken to reach maximum concentration of M66223 after admistration is reported.
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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)
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Part 1A and Part 1B: Apparent Terminal Half-Life (t1/2) of M6223
기간: 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)
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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.
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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)
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Part 1A and Part 1B: Elimination Rate Constant (Lambda z) of M6223
기간: 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)
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Elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.
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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)
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Part 1B: Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa
기간: Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
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Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
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Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
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Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp Alfa
기간: Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
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Ctrough is the concentration prior to study drug administration.
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Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
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Part IA and 1B: Number of Participants With Positive Antidrug Antibody (ADA) Assays
기간: 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)
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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.
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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)
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Part 1A and IB: Best Overall Response According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
기간: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
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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.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
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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
기간: From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
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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.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
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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
기간: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
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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.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
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Part 1A and 1B: Disease Control According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
기간: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
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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.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
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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
기간: From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
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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.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
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Part 1A and 1B: Overall Survival
기간: From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)
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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.
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From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 7월 10일
기본 완료 (실제)
2023년 6월 23일
연구 완료 (실제)
2023년 6월 23일
연구 등록 날짜
최초 제출
2020년 6월 30일
QC 기준을 충족하는 최초 제출
2020년 6월 30일
처음 게시됨 (실제)
2020년 7월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 13일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
우리는 임상 시험 데이터의 책임 있는 공유를 통해 공중 보건을 향상시키기 위해 최선을 다하고 있습니다.
미국과 유럽 연합에서 승인된 제품에 대한 신제품 또는 새로운 적응증이 승인된 후, 연구 스폰서 및/또는 계열사는 연구 프로토콜, 익명화된 환자 데이터 및 연구 수준 데이터, 수정된 임상 연구 보고서를 공유합니다. 적법한 연구를 수행하는 데 필요한 경우 요청 시 자격을 갖춘 과학 및 의학 연구원과 공유합니다.
데이터 요청 방법에 대한 자세한 내용은 당사 웹사이트 bit.ly/IPD21에서 확인할 수 있습니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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AstraZeneca모집하지 않고 적극적으로Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, 위암, 유방암 및 난소암미국, 프랑스, 영국, 대한민국
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