研究单位：[1]Ellipses Pharma[2]Shanghai Chest Hospital,Shanghai,Changning District, 交通大学 邮政编码,China,200052[3]Fudan University Shanghai Cancer Center,Shanghai,Dongan Rd, 270, Xuhui District,China,200032[4]Henan Cancer Hospital,Henan,Jinshui District, Zhengzhou,China,450003[5]Linyi Cancer Hospital,Linyi,Linyi, Lanshan District, Shandong,China,276001[6]The First Affiliated Hospital of Xiamen University,Fujian,Siming District, Xiamen,China,361026[7]Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South,Changsha,Tongzipo Road, Yuelu District,China,410013[8]Shanxi Cancer Hospital,Shanxi,Xinghualing District, Taiyuan,China,030013[9]Affiliated Hospital of Hebei University,Baoding,Yuhua East Road 212, Lianchi District,China[10]Seoul St. Mary Hospital,Seoul,Banpo-daero 222, Banpo-dong, Seocho-gu,Korea, Republic of[11]Dong-A University Hospital,Busan,Daesingongwon-ro 26, Seo-gu,Korea, Republic of[12]Seoul National University Bundang Hospital,Seoul,Gumi-ro 82 173(baekchilsipsam)beo, Bundang-gu, Seongnam-si,Korea, Republic of[13]Samsung Medical Center,Seoul,Irwon-ro 81, Gangnam-gu,Korea, Republic of[14]South Korea University Hospital,Seoul,Jongno-gu, Daehak-ro, 101,Korea, Republic of,03080[15]Asan Medical Center,Seoul,Olympic-ro 88 43-gil, Songpa-gu,Korea, Republic of[16]Chungbuk National University Hospital,Cheongju-si,Sunhuanro 776 (1), Heungduk-gu, Cheongju-city,Korea, Republic of[17]Cha University Bundang Medical Center,Gyeonggi-do,Yatap-ro 59, Bundang-gu, Seongnam,Korea, Republic of[18]Kaohsiung Medical University Chung-Ho Memorial Hospital,Kaohsiung,No. 100號, Ziyou 1st Rd, Sanmin District,Taiwan,80756[19]Changhua Christian Hospital,Changhua,No. 176, Zhonghua Rd,Taiwan,500[20]Tapei Medical University - Shuang-Ho Hospital Ministry of Health and Welfare,New Taipei City,No. 291, Zhongzheng Rd, Zhonghe District,Taiwan,235[21]Chang Gung Medical Foundation Linkou,Taoyuan,No.5, Fuxing St., Guishan Dist,Taiwan[22]Chi Mei Hospital Liouying,Tainan,Yongkang District, Zhonghua Rd, 710,Taiwan
The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib (a PARP inhibitor) in two cancers where there is a high unmet need: extensive stage small cell lung cancer (SCLC) and ATM-negative gastric cancer (GC). EP0057-202 is a non-comparative, multi-arm, multi-centre, open label, Phase 2 study to determine the efficacy, safety, and tolerability of EP0057 in combination with olaparib (an approved PARP inhibitor) in defined patient populations with relapsed* GC and SCLC. *(see Eligibility Criteria for definition of "relapse" for each tumour type/population) The treatment cohorts will open sequentially at the Sponsor's discretion and patients may be enrolled into each cohort concurrently. EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.
