計劃書編號ROMast-001
NCT Number(ClinicalTrials.gov Identfier)NCT06174987
尚未開始召募
2024-02-01 - 2028-04-15
其他
召募中2
ICD-10C18.8
大腸重疊部位之惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9153.8
大腸其他特定部位之惡性腫瘤
一項提供持續取得試驗藥物與評估試驗藥物之長期安全性的主展期試驗
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試驗申請者
艾昆緯股份有限公司
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試驗委託 / 贊助單位名稱
艾昆緯股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
大腸直腸癌實質固態瘤
試驗目的
主要目的為替持續自試驗藥物為主的治療獲得臨床效益的受試者提供治療，並繼續監測試驗藥物持續治療的長期安全性。
藥品名稱
Trastuzumab deruxtecan
主成份
Trastuzumab deruxtecan
劑型
Lyophilized powder for injection
劑量
100
評估指標
導致試驗藥物停藥和/或劑量減少的 TEAEs、治療期間出現的嚴重不良事件 (TESAEs) 和治療期間出現的特別關注之不良事件 (AESIs)。
主要納入條件
Inclusion Criteria:
-Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.
-Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
-No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).
-Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.
-Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
-No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).
主要排除條件
Exclusion Criteria:
-Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
-Participant who has been off T-DXd therapy for >18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study
-Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
-Participant who has been off T-DXd therapy for >18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study
試驗計畫預計收納受試者人數
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台灣人數
5 人
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全球人數
150 人
