計劃書編號ROMast-001
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
2026/04/01
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
Subjects must meet all of the following criteria to be eligible for enrollment into the study:
1. Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
1. 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).
2. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Methods considered as highly effective methods of contraception can be found in Section 10.3.1.
a. If the subject is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a
minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone test.
3. Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration.
4. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening, and throughout
the Treatment Period in the compound-specific sub-protocol (Appendix A) and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.Subjects who meet any of the following criteria will be disqualified from entering the study:
5. Subjects who permanently discontinued from the study drug in the parent study.
6. Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject.
7. Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.
Note: In countries where, according to local institutional requirements, it is not feasible to switch subjects to the
commercial drug through prescription, even if fully reimbursed, subjects will be considered eligible to participate in
the Rollover Study.
1. Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
1. 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).
2. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Methods considered as highly effective methods of contraception can be found in Section 10.3.1.
a. If the subject is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a
minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone test.
3. Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration.
4. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening, and throughout
the Treatment Period in the compound-specific sub-protocol (Appendix A) and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.Subjects who meet any of the following criteria will be disqualified from entering the study:
5. Subjects who permanently discontinued from the study drug in the parent study.
6. Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject.
7. Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.
Note: In countries where, according to local institutional requirements, it is not feasible to switch subjects to the
commercial drug through prescription, even if fully reimbursed, subjects will be considered eligible to participate in
the Rollover 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
