ZymeWorks Has Dosed The First Patient In The First-In-Human Phase 1 Trial To Evaluate The Safety And Tolerability Of The Investigational Therapy ZW171 For Advanced Or Metastatic Ovarian Cancer, NSCLC, And Other MSLN-expressing Cancers
ZymeWorks Has Dosed The First Patient In The First-In-Human Phase 1 Trial To Evaluate The Safety And Tolerability Of The Investigational Therapy ZW171 For Advanced Or Metastatic Ovarian Cancer, NSCLC, And Other MSLN-expressing Cancers
The Phase 1 study is a two-part, open-label multi-center study that is expected to enroll approximately 160 adult patients with advanced MSLN-expressing cancers. Part 1 of the study will evaluate the safety and tolerability of ZW171 and involve dose escalation in patients with advanced ovarian and NSCLC, with secondary endpoints assessing pharmacokinetics and confirmed objective response rate. Part 2 of the study will involve dose expansion in three cohorts (ovarian cancer, NSCLC, and a basket cohort enrolling patients with any MSLN-expression) and will evaluate the anti-tumor activity of ZW171, with primary endpoints focused on safety and tolerability and secondary endpoints assessing progression-free survival, duration of response rates, and overall survival. The Company expects to conduct the Phase 1 study at investigator sites in the United States, Europe, and the Asia-Pacific region.
第1階段研究是一個兩部分的、開放標籤的多中心研究，預計將招募大約160名患有愛文思控股的癌症的成年患者。研究的第1部分將評估ZW171的安全性和耐受性，並涉及劑量逐步增加，納入患有晚期卵巢癌和非小細胞肺癌的患者，輔助終點評估藥代動力學和確認的客觀反應率。研究的第2部分將在三個隊列中進行劑量擴大（卵巢癌、非小細胞肺癌以及一個籃子隊列，納入任何MSLN表達的患者），並評估ZW171的抗腫瘤活性，其主要終點將集中在安全性和耐受性上，次要終點評估無進展生存期、反應持續時間和總存活率。公司預計將在美國、歐洲和亞太地域板塊的調查地點進行第1階段研究。
譯文內容由第三人軟體翻譯。
