計劃書編號MK-1022-011
NCT Number(ClinicalTrials.gov Identfier)NCT06596694
試驗執行中
2024-10-01 - 2032-12-31
Phase I/II
召募中3
ICD-10C16.9
胃惡性腫瘤
ICD-10C7A.092
胃惡性類癌
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9151.9
胃惡性腫瘤
一項第1／2期試驗，評估Patritumab Deruxtecan對於胃腸道癌症的安全性和療效
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試驗申請者
美商默沙東藥廠股份有限公司台灣分公司
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試驗委託 / 贊助單位名稱
美商默沙東藥廠股份有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2026/06/17
試驗主持人及試驗醫院
適應症
胃腸道癌症
試驗目的
主要目的：
(1) 由盲性獨立中央審查（BICR）根據實體腫瘤反應評估標準第1.1版（RECIST 1.1）評估確認之客觀反應率（ORR）（第1群組、第2群組，以及在第3群組中接受初步建議的第2期劑量[RP2D]之受試者）
(2) 評估patritumab deruxtecan（HER3-DXd）的安全性和耐受性
藥品名稱
注射劑
主成份
HER3 directed ADC comprising a fully human anti-HER3 IgG1 patritumab, includes a topoisomerase I inhibitor payload (DXd MAAA-1181a)
劑型
270
劑量
100mg
評估指標
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主要納入條件
本試驗的對象為：
• 年滿18歲
• 患有視為晚期的大腸直腸癌、膽道癌或肝細胞癌
• 針對其癌症已接受1或2種先前療法
約130人將參加本試驗。即使您符合這些基本要求，也可能有會使您無法參加本試驗的原因。試驗醫師或人員將與您討論這些原因。
• 年滿18歲
• 患有視為晚期的大腸直腸癌、膽道癌或肝細胞癌
• 針對其癌症已接受1或2種先前療法
約130人將參加本試驗。即使您符合這些基本要求，也可能有會使您無法參加本試驗的原因。試驗醫師或人員將與您討論這些原因。
主要排除條件
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
Has evidence of any leptomeningeal disease
Has clinically significant corneal disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
The main exclusion criteria include but are not limited to the following:
Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
Has evidence of any leptomeningeal disease
Has clinically significant corneal disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
試驗計畫預計收納受試者人數
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台灣人數
9 人
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全球人數
180 人
