Spots Global Cancer Trial Database for EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
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Trial Identification
Brief Title: EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
Official Title: A Phase 2 Multi-arm, Open Label Study to Assess the Safety and Efficacy of EP0057 in Combination With Olaparib in Defined Populations of Patients With Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
Study ID: NCT05411679
Study Description
Brief Summary: 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.
Detailed Description: EP0057 - 202 is a Phase 2 multi arm, open label study in defined populations of patients with SCLC and GC. The Primary objectives of Arm 1 will be to investigate the efficacy, as defined by best Objective Response Rate (ORR) of EP0057 in combination with Olaparib in patients with ataxia-telangiectasia mutated protein (ATM)-negative relapsed, advanced GC. The Primary objectives of Arm 2 will be to investigate the efficacy, as defined by the best ORR of EP0057 in combination with Olaparib in patients with relapsed extensive stage SCLC. The secondary objectives of both arms will be to further investigate the efficacy of EP0057 in combination with olaparib in the target patient population of each arm by assessment of the following: * Progression-free survival (PFS) * Overall survival (OS) * Duration of overall response (DoR) * Disease control rate (DCR) Secondary objectives of arms 1 and 2 also include exploring the safety and tolerability of EP0057 when combined with olaparib in patients with GC and SCLC. Exploratory objectives may or may not be performed during the course of the study, but if so, where available at the time of publication, results from these analyses will be reported in the clinical study report (CSR). Exploratory objectives are to: * Examine the PK characteristics of EP0057 in combination with olaparib * Investigate the impact of HRD (homologous recombination deficiency) status on primary and secondary endpoints, as analysed by sub-groups of HRD status. It is estimated that approximately 115 patients will be enrolled into the study. The study will aim to recruit 34 patients across both arms of the study in stage 1. The study will then aim to recruit an additional 81 patients across both arms in the second stage.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Shanghai Chest Hospital, Shanghai, Changning District, 交通大学 邮政编码, China
Fudan University Shanghai Cancer Center, Shanghai, Dongan Rd, 270, Xuhui District, China
Henan Cancer Hospital, Henan, Jinshui District, Zhengzhou, China
Linyi Cancer Hospital, Linyi, Linyi, Lanshan District, Shandong, China
The First Affiliated Hospital of Xiamen University, Fujian, Siming District, Xiamen, China
Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South, Changsha, Tongzipo Road, Yuelu District, China
Shanxi Cancer Hospital, Shanxi, Xinghualing District, Taiyuan, China
Affiliated Hospital of Hebei University, Baoding, Yuhua East Road 212, Lianchi District, China
Seoul St. Mary Hospital, Seoul, Banpo-daero 222, Banpo-dong, Seocho-gu, Korea, Republic of
Dong-A University Hospital, Busan, Daesingongwon-ro 26, Seo-gu, Korea, Republic of
Seoul National University Bundang Hospital, Seoul, Gumi-ro 82 173(baekchilsipsam)beo, Bundang-gu, Seongnam-si, Korea, Republic of
Samsung Medical Center, Seoul, Irwon-ro 81, Gangnam-gu, Korea, Republic of
South Korea University Hospital, Seoul, Jongno-gu, Daehak-ro, 101, Korea, Republic of
Asan Medical Center, Seoul, Olympic-ro 88 43-gil, Songpa-gu, Korea, Republic of
Chungbuk National University Hospital, Cheongju-si, Sunhuanro 776 (1), Heungduk-gu, Cheongju-city, Korea, Republic of
Cha University Bundang Medical Center, Gyeonggi-do, Yatap-ro 59, Bundang-gu, Seongnam, Korea, Republic of
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, No. 100號, Ziyou 1st Rd, Sanmin District, Taiwan
Changhua Christian Hospital, Changhua, No. 176, Zhonghua Rd, Taiwan
Tapei Medical University - Shuang-Ho Hospital Ministry of Health and Welfare, New Taipei City, No. 291, Zhongzheng Rd, Zhonghe District, Taiwan
Chang Gung Medical Foundation Linkou, Taoyuan, No.5, Fuxing St., Guishan Dist, Taiwan
Chi Mei Hospital Liouying, Tainan, Yongkang District, Zhonghua Rd, 710, Taiwan
Contact Details
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