这项开放标签、多中心、延续性研究将为从 Daiichi Sankyo, Inc.(DS)或 DS/Astra Zeneca(AZ)赞助的研究中所接受不同治疗并获得效益的参与者提供持续治疗。
适应症:Advanced Cancer、Metastatic Cancer
入组条件
纳入标准
- Participants must meet all of the following criteria to be eligible for enrollment into the study:
- Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
- No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).
- 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.
- a. If the participant 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.
- 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.
- 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 and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.
排除标准
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Participants who permanently discontinued from the study drug in the parent study.
- 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.
- Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年11月5日。