MK-1200 在晚期实体瘤参与者中的安全性和有效性
2026年5月11日 更新者：Merck Sharp & Dohme LLC
一项 1/2 期开放标签研究，旨在评估 MK-1200 对晚期实体瘤参与者的安全性和有效性
本研究的目的是评估 MK-1200 单药治疗对已接受或不耐受的晚期/转移性胃/胃食管交界处 (GEJ) 癌、食道癌、胆道癌和胰腺导管腺癌参与者的疗效和安全性所有已知可带来临床益处的治疗方法。
该研究的第 1 部分将是剂量递增以确定最大耐受剂量 (MTD)。
第 2 部分将评估 2 种不同剂量的 MK-1200 的安全性和有效性
研究概览
研究类型
介入性
注册 (实际的)
13
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100142
- Beijing Cancer hospital-Digestive Oncology ( Site 0401)
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Fujian
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Fuzhou、Fujian、中国、350000
- Fujian Cancer Hospital-oncology department ( Site 0409)
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Jiangsu
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Huai'an、Jiangsu、中国、223300
- First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)
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Haifa、以色列、3109601
- Rambam Health Care Campus-Oncology Division ( Site 0602)
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Jerusalem、以色列、9112001
- Hadassah Medical Center ( Site 0604)
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Petah Tikva、以色列、4941492
- Rabin Medical Center-Oncology ( Site 0603)
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Ramat Gan、以色列、5265601
- Sheba Medical Center ( Site 0605)
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Tel Aviv、以色列、6423906
- Sourasky Medical Center ( Site 0601)
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Region M. de Santiago
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Santiago、Region M. de Santiago、智利、8420383
- Bradfordhill-Clinical Area ( Site 0301)
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Victoria
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Melbourne、Victoria、澳大利亚、3004
- The Alfred Hospital ( Site 0103)
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Kentucky
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Louisville、Kentucky、美国、40202
- The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
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Michigan
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Grand Rapids、Michigan、美国、49546
- START Midwest ( Site 0014)
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Texas
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San Antonio、Texas、美国、78229
- South Texas Accelerated Research Therapeutics (START) ( Site 0005)
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Utah
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West Valley City、Utah、美国、84119
- START Mountain Region ( Site 0015)
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Virginia
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Charlottesville、Virginia、美国、22908
- University of Virginia Health System-Hematology-Oncology ( Site 0009)
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Seoul、韩国、06351
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 确诊的晚期（不可切除和/或转移性）实体瘤：胃癌（包括胃食管结合部癌）、食管癌、胆道癌或胰腺导管腺癌
- 由于之前的抗癌治疗而经历过不良事件 (AE) 的参与者必须已恢复到 < 1 级或基线
- 感染人类免疫缺陷病毒 (HIV) 的参与者必须在抗逆转录病毒治疗中艾滋病毒得到良好控制
- 乙型肝炎表面抗原 (HBsAg) 阳性参与者如果已接受乙型肝炎病毒 (HBV) 抗病毒治疗至少 4 周且 HBV 病毒载量未检测到，则符合资格
- 如果丙型肝炎病毒 (HCV) 病毒载量未检测到，有丙型肝炎病毒 (HCV) 感染史的参与者符合资格
- 在 1 或 2 种先前疗法中或之后接受并进展
排除标准：
- 活动性严重消化系统疾病
- 主要心血管疾病史
- 有急性心肌梗塞病史；不稳定型心绞痛；第一次研究干预前 6 个月内发生中风或短暂性脑缺血发作
- 心脏起搏器的使用
- 无法通过药物控制的糖尿病或高血压
- 有卡波西肉瘤和/或多中心卡斯尔曼病病史的艾滋病毒感染者
- 在研究干预前 4 周内接受过既往全身抗癌治疗，包括研究药物
- 研究干预开始后 2 周内接受过放射治疗，或有放射相关毒性，需要皮质类固醇
- 已知的其他恶性肿瘤正在进展或在过去 2 年内需要积极治疗
- 已知的活动性中枢神经系统 (CNS) 转移和/或癌性脑膜炎
- 活动性感染需要全身治疗
- 尚未从大手术中充分恢复或有持续的手术并发症
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：第 1 部分：MK-1200
在第 1 部分中，参与者将每两周 (Q2W) 通过静脉 (IV) 输注逐渐增加剂量的 MK-1200，直到满足任何停药标准。
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静脉输液
一种或多种预防性止吐药（例如
5-HT3 受体拮抗剂、地塞米松、神经激肽-1 受体拮抗剂等）可根据参与者之前对止吐药物的反应和个人因素进行选择，并在 MK-1200 输注之前按照批准的产品标签给药
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实验性的：Part 2: MK-1200 Cohort A
In Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met.
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静脉输液
一种或多种预防性止吐药（例如
5-HT3 受体拮抗剂、地塞米松、神经激肽-1 受体拮抗剂等）可根据参与者之前对止吐药物的反应和个人因素进行选择，并在 MK-1200 输注之前按照批准的产品标签给药
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实验性的：Part 2: MK-1200 Cohort B
In Part 2, participants in Cohort B will receive Dose 1 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met.
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静脉输液
一种或多种预防性止吐药（例如
5-HT3 受体拮抗剂、地塞米松、神经激肽-1 受体拮抗剂等）可根据参与者之前对止吐药物的反应和个人因素进行选择，并在 MK-1200 输注之前按照批准的产品标签给药
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1
大体时间：During the first two 14-day cycles (Up to approximately 28 days)
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The occurrence of any of the following toxicities within 28 days after the first dose of study intervention were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration:
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During the first two 14-day cycles (Up to approximately 28 days)
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Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2
大体时间：Up to approximately 12 months
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An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experienced an AE is reported for each arm.
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Up to approximately 12 months
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Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2
大体时间：Up to approximately 9 months
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An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who discontinued study intervention due to an AE is reported for each arm.
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Up to approximately 9 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) - Part 2 Cohort A
大体时间：Up to approximately 13 months
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ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR).
As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention.
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Up to approximately 13 months
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ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
大体时间：Up to approximately 13 months
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ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator.
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Up to approximately 13 months
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Area Under the Concentration Versus Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-1200-Antibody-Drug Conjugate (ADC) - Parts 1 and 2
大体时间：Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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AUC0-336 was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to 336 Hours.
Blood samples were collected at pre-specified timepoints to determine the AUC0-336 of the MK-1200-ADC.
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Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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AUC0-336 of the Conjugated Toxin Payload (KL610023) - Parts 1 and 2
大体时间：Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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AUC0-336 was defined as the area under the concentration versus time curve of KL610023 from time 0 to 336 Hours.
Blood samples were collected at pre-specified timepoints to determine AUC0-336 of KL610023.
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Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of MK-1200-ADC - Parts 1 and 2
大体时间：Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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AUC0-tau was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose).
Blood samples were collected at pre-specified timepoints to determine AUC0-tau of the MK-1200-ADC.
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Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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AUC0-tau of KL610023 - Parts 1 and 2
大体时间：Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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AUC0-tau is defined as the area under the concentration versus time curve of KL610023 from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose).
Blood samples were collected at pre-specified timepoints to determine AUC0-tau of KL610023.
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Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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Minimum Concentration (Cmin) of MK-1200-ADC - Part 1 & Part 2
大体时间：Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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Cmin was defined as the minimum concentration of MK-1200-ADC observed in plasma after its administration and just prior to administration of a subsequent dose.
Blood samples were collected at pre-specified timepoints to determine Cmin of the MK-1200-ADC.
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Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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Cmin of KL610023 - Part 1 & Part 2
大体时间：Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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Cmin was defined as the minimum concentration of KL610023 observed in plasma after its administration and just prior to administration of a subsequent dose.
Blood samples were collected at pre-specified timepoints to determine Cmin of KL610023.
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Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
|
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Maximum Concentration (Cmax) of MK-1200-ADC - Part 1 & Part 2
大体时间：Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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Cmax was defined as the maximum or 'peak' concentration of MK-1200-ADC observed after its administration.
Blood samples were collected at pre-specified timepoints to determine Cmax of the MK-1200-ADC.
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Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
|
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Cmax of KL610023 - Part 1 & Part 2
大体时间：Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
|
Cmax was defined as the maximum or 'peak' concentration of KL610023 observed after its administration.
Blood samples were collected at pre-specified timepoints to determine Cmax of KL610023.
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Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
|
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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
大体时间：Up to approximately 13 months
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For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from the first documented evidence of a CR or a PR until Progressive Disease (PD) or death due to any cause, whichever occurred first.
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions was also considered PD.
As pre-specified by the protocol, DOR for Part 2 Cohort A was planned to be assessed by BICR and was to include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention.
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Up to approximately 13 months
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DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
大体时间：Up to approximately 13 months
|
For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from the first documented evidence of a CR or a PR until PD or death due to any cause, whichever occurs first.
Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.
The appearance of one or more new lesions is also considered PD.
The DOR as assessed by the investigator is reported.
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Up to approximately 13 months
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Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
大体时间：Up to approximately 13 months
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PFS was defined as the time from randomization to the first documented PD by BICR or death due to any cause, whichever occurs first.
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions was also considered PD.
As pre-specified by the protocol, PFS for Part 2 Cohort A was planned to be assessed by BICR and was to only include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention.
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Up to approximately 13 months
|
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PFS Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
大体时间：Up to approximately 13 months
|
PFS was defined as the time from randomization to the first documented PD by investigator or death due to any cause, whichever occurs first.
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
The appearance of one or more new lesions was also considered PD.
PFS as assessed by the investigator is reported.
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Up to approximately 13 months
|
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Overall Survival (OS) - Part 1 & Part 2
大体时间：Up to approximately 13 months
|
OS was defined as the time from randomization to death due to any cause.
|
Up to approximately 13 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Medical Director、Merck Sharp & Dohme LLC
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年2月28日
初级完成 (实际的)
2025年6月17日
研究完成 (实际的)
2025年6月17日
研究注册日期
首次提交
2024年1月26日
首先提交符合 QC 标准的
2024年1月26日
首次发布 (实际的)
2024年2月5日
研究记录更新
最后更新发布 (实际的)
2026年6月5日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 1200-002
- U1111-1298-7820 (注册表标识符：UTN)
- MK-1200-002 (其他标识符：MSD)
- 2023-508684-68-00 (注册表标识符：EU CT)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.