研究单位：[1]Turning Point Therapeutics, Inc.[2]Zai Lab (Shanghai) Co., Ltd.[3]Yuma Regional Medical Center PHASE 2,Yuma,Arizona,United States,85364[4]City of Hope PHASE 2,Duarte,California,United States,91010[5]Adventist Health Glendale PHASE 2,Glendale,California,United States,91206[6]MemorialCare Long Beach PHASE 2,Long Beach,California,United States,90806[7]Pacific Shores Oncology PHASE 2,Long Beach,California,United States,90813[8]UC Irvine Health, Chao Family Comprehensive Cancer Center PHASE 1 (recruiting) & PHASE 2 (recruiting),Orange,California,United States,92868[9]Ventura County Hematology Oncology Specialists PHASE 2,Oxnard,California,United States,93030[10]UC San Diego Moores Cancer Center PHASE 2,San Diego,California,United States,92093[11]St Joseph's Heritage Healthcare PHASE 2,Santa Rosa,California,United States,95403[12]University of Colorado Denver PHASE 1 (recruiting) & PHASE 2 (recruiting),Aurora,Colorado,United States,80045[13]Georgetown Lombardi Comprehensive Cancer Center PHASE 2,Washington,District of Columbia,United States,20007[14]Johns Hopkins Kimmel Cancer Center PHASE 2,Washington,District of Columbia,United States,20016[15]Memorial Healthcare System PHASE 2,Hollywood,Florida,United States,33021[16]Cancer Specialists of North Florida PHASE 2,Jacksonville,Florida,United States,32256[17]Ocala Oncology PHASE 2,Ocala,Florida,United States,34474[18]Moffitt Cancer Center PHASE 2,Tampa,Florida,United States,33612[19]University Cancer and Blood Center PHASE 2,Athens,Georgia,United States,30607[20]Columbus Regional Research Institute PHASE 2,Columbus,Georgia,United States,31904[21]Hawaii Cancer Care PHASE 2,Honolulu,Hawaii,United States,96813[22]University of Chicago PHASE 2,Chicago,Illinois,United States,60637[23]Illinois Cancer Care PHASE 2,Peoria,Illinois,United States,61615[24]Fort Wayne Medical Oncology and Hematology PHASE 2,Fort Wayne,Indiana,United States,46845[25]Beacon Health PHASE 2,South Bend,Indiana,United States,46601[26]Pontchartrain Cancer Center (QCCA) PHASE 2,Covington,Louisiana,United States,70433[27]University of Maryland School of Medicine PHASE 2,Baltimore,Maryland,United States,21201[28]The Center for Cancer & Blood Disorders - Maryland PHASE 2,Bethesda,Maryland,United States,20817[29]Frederick Health - James M Stockman Cancer Institute PHASE 2,Frederick,Maryland,United States,21702[30]Massachusetts General Hospital PHASE 1 (recruiting) & PHASE 2 (recruiting),Boston,Massachusetts,United States,02114[31]MGH Satellite - Dana-Farber Cancer Institute PHASE 2,Boston,Massachusetts,United States,02215[32]Southcoast PHASE 2,Fairhaven,Massachusetts,United States,02719[33]University of Michigan Rogel Cancer Center PHASE 2,Ann Arbor,Michigan,United States,48109[34]Karmanos Cancer Institute PHASE 2,Detroit,Michigan,United States,48201[35]Henry Ford Health System PHASE 2,Detroit,Michigan,United States,48202[36]Sparrow Health System PHASE 2,Lansing,Michigan,United States,48912[37]Regions Hospital Cancer Care Center PHASE 2,Saint Paul,Minnesota,United States,55101[38]Central Care Cancer Center PHASE 2,Bolivar,Missouri,United States,65613[39]Mosaic Life Care PHASE 2,Saint Joseph,Missouri,United States,64507[40]Washington University Siteman Cancer Center PHASE 2,Saint Louis,Missouri,United States,63110[41]New Jersey Cancer Care and Blood Disorders PHASE 2,Belleville,New Jersey,United States,07109[42]Summit Medical Group PHASE 2,Berkeley Heights,New Jersey,United States,07932[43]Rutgers Cancer Institute PHASE 2,New Brunswick,New Jersey,United States,08901[44]NYU Langone Health PHASE 2,New York,New York,United States,10016[45]Memorial Sloan Kettering Cancer Center PHASE 1 (recruiting) & PHASE 2 (Recruiting),New York,New York,United States,10065[46]Southeastern Medical Oncology Center PHASE 2,Goldsboro,North Carolina,United States,27534[47]Gabrail Cancer Center PHASE 2,Canton,Ohio,United States,44718[48]TriHealth Cancer Institute PHASE 2,Cincinnati,Ohio,United States,45220[49]Cleveland Clinic PHASE 2,Cleveland,Ohio,United States,4419[50]Ohio State Wexner Medical Center PHASE 2,Columbus,Ohio,United States,43210[51]OhioHealth PHASE 2,Columbus,Ohio,United States,43214[52]University of Toledo PHASE 2,Toledo,Ohio,United States,22031[53]Oklahoma Cancer Specialists and Research Institute Tulsa, OK (OCSRI) (QCCA) PHASE 2,Tulsa,Oklahoma,United States,74146[54]Gettysburg PHASE 2,Gettysburg,Pennsylvania,United States,17325[55]Fox Chase Cancer Center PHASE 2,Philadelphia,Pennsylvania,United States,19111[56]Sanford Health PHASE 2,Sioux Falls,South Dakota,United States,57104[57]Avera Cancer Institute Center for Precision Oncology PHASE 2,Sioux Falls,South Dakota,United States,57105[58]Baptist Memorial Hospital Baptist Cancer Center PHASE 2,Memphis,Tennessee,United States,38120[59]UT Southwestern Medical Center PHASE 2,Dallas,Texas,United States,75390[60]MD Anderson Cancer Center - The University of Texas PHASE 2,Houston,Texas,United States,77030[61]Oncology Consultants P.A. PHASE 2,Houston,Texas,United States,77030[62]Lumi Research PHASE 2,Kingwood,Texas,United States,77339[63]Utah Cancer Specialists PHASE 2,Salt Lake City,Utah,United States,84106[64]Virginia Cancer Specialists PHASE 2,Fairfax,Virginia,United States,22031[65]Hematology Oncology Associates of Fredericksburg PHASE 2,Fredericksburg,Virginia,United States,22408[66]PeaceHealth - Bellingham (NW) PHASE 2,Bellingham,Washington,United States,98225[67]UW Seattle Cancer Care Alliance PHASE 2,Seattle,Washington,United States,98109[68]ThedaCare PHASE 2,Appleton,Wisconsin,United States,54911[69]The Chris O-Brien Lifehouse PHASE 2,Camperdown,New South Wales,Australia,2050[70]Flinders Medical Centre PHASE 2,Bedford Park,South Australia,Australia,5042[71]Peter MacCallum Cancer Center PHASE 2,Melbourne,Victoria,Australia,3501[72]UZA Research Unit Oncology- route 55 PHASE 2,Edegem,Belgium,B-2650[73]UZ Leuven - Campus Gasthuisberg PHASE 2,Leuven,Belgium,B-3000[74]Cross Cancer Institute PHASE 2,Edmonton,Alberta,Canada,T6G 1Z2[75]BC Cancer PHASE 2,Vancouver,British Columbia,Canada,V5Z 4E11[76]William Osler Health System PHASE 2,Brampton,Ontario,Canada,L6R 37R[77]The Ottawa Hospital PHASE 2,Ottawa,Ontario,Canada,K1H 8L6[78]Princess Margaret Cancer Center at University Health Network PHASE 2,Toronto,Ontario,Canada,M5G 2C1[79]Anhui Provincial Hospital/Oncology Department PHASE 2,Hefei,Anhui,China[80]Cancer Hospital Chinese Academy of Medical Sciences/Cancer Institute PHASE 2,Chaoyang,Beijing,China[81]Beijing Cancer Hospital/Oncology Department PHASE 2,Haidian,Beijing,China[82]West China Hospital Sichuan University/Lung cancer center PHASE 2,Wenjiang,Chengdu,China[83]Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center PHASE 2,Daping,Chongqing,China[84]The first Hospital Affiliated to AMU (Southwest Hospital)/Pneumology Department PHASE 2,Shapingba,Chongqing,China[85]The First Affiliated Hospital of Xiamen University/Medical oncology Department PHASE 2,Fujian,Fujian,China[86]Fujian Provincial Cancer Hospital/Thoracic oncology Department PHASE 2,Fuzhou,Fujian,China[87]Guangdong Provincial People''s Hospital PHASE 2,Guangzhou,Guangdong,China[88]The Affiliated Tumor Hospital of Harbin Medical University/Medical Oncology Department PHASE 2,Heilongjiang,Heilongjiang,China[89]Henan Cancer Hospital/The 1st pneumology department PHASE 2,Zhengzhou,Henan,China[90]Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department PHASE 2,Wuhan,Hubei,China[91]The Second XIANGYA Hospital Of Central South University/Oncology Department PHASE 2,Changsha,Hunan,China[92]The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine PHASE 2,Changsha,Hunan,China[93]Nanjing Drum Tower Hospital PHASE 2,Nanjing,Jiangsu,China[94]XuZhou Central Hospital/Oncology Department PHASE 2,Xuzhou,Jiangsu,China[95]Jilin Cancer Hospital/Medical Oncology Department PHASE 2,Jilin,Jilin,China[96]The First Hospital of Jilin University/Oncology Center Department PHASE 2,Jilin,Jilin,China[97]Liaoning Cancer hospital PHASE 2,Shenyang,Liaoning,China[98]Jinan Central Hospital/Medical Oncology Department PHASE 2,Shandong,Shandong,China[99]Weifang People''s Hospital/Medical Oncology Department PHASE 2,Shandong,Shandong,China[100]Shanghai Chest Hospital/Chest Cancer Institute PHASE 2,Shanghai,Shanghai,China[101]Shanghai Chest Hospital/Oncology Department PHASE 2,Shanghai,Shanghai,China[102]Shanxi Bethune Hospital PHASE 2,Shanxi,Shanxi,China[103]Tangdu Hospital PHASE 2,Shanxi,Shanxi,China[104]Sichuan Cancer Hospital/Medical Oncology Department PHASE 2,Sichuan,Sichuan,China[105]Hunan Cancer Hospital/Medical Oncology Department PHASE 2,Yuelu,Yuelu,China[106]The First Affiliated Hospital of Gannan Medical University PHASE 2,Zhanggong,Zhanggong,China[107]Sir Run Run Shaw Hospital Zhejiang University School of Medicine/Oncology Department PHASE 2,Hangzhou,Zhejiang,China[108]Zhejiang Cancer Hospital/Thoracic Oncology Department PHASE 2,Hangzhou,Zhejiang,China[109]The First Affiliated Hospital Zhejiang University School of Medicine/Respiratory medicine Department PHASE 2,Zhejiang,Zhejiang,China[110]Rigshospitalet, University Hospital of Copenhagen PHASE 2,Copenhagen,Denmark,2100[111]Centre Hospitalier Regional Vuniversitaire Brest PHASE 2,Brest,France,29200[112]Centre Georges-Francois PHASE 2,Dijon,France,21079[113]Centre Hospitalier Universitarie Arie Grenoble Alpes (CHUGA) PHASE 2,Grenoble,France,38043[114]Hospital de la Timone PHASE 2,Marseille,France,13005[115]Centre Antoine Lacassagne Phase 2,Nice,France,06189[116]CHU Poitiers PHASE 2,Poitiers,France,86000[117]Hopital D''Instruction Des Armees Begin PHASE 2,Saint-Mandé,France,94160[118]Institut Gustave Roussy PHASE 2,Villejuif,France,94805[119]Evangelische Lungenklinik Berlin PHASE 2,Berlin,Germany,13125[120]Centrum für Integrierte Onkologie - Universitaetsklinikum Koeln PHASE 2,Cologne,Germany,50937[121]University Clinic Carl Gustav Carus PHASE 2,Dresden,Germany,01307[122]University Hospital Heidelberg PHASE 2,Heidelberg,Germany[123]Queen Mary Hospital PHASE 2,Hong Kong,Hong Kong[124]Queen Mary Hospital PHASE 2,Hong Kong,Hong Kong[125]Hong Kong United Oncology Centre PHASE 2,Kowloon,Hong Kong[126]Prince of Wales Hospital PHASE 2,Sha Tin,Hong Kong[127]Semmelweis Egyetem PHASE 2,Budapest,Hungary,1083[128]Országos Korányi TBC és Pulmonológiai Intézet Budapest PHASE 2,Budapest,Hungary,1121[129]Centro Di Riferimento PHASE 2,Aviano,Italy,33081[130]Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico PHASE 2,Milan,Italy,20122[131]Fondazione IRCCS Istituto Nazionale Dei Tumori PHASE 2,Milan,Italy,20133[132]Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cerevello" PHASE 2,Palermo,Italy[133]Arcispedale S. Maria Nuova PHASE 2,Reggio Emilia,Italy,42123[134]IRCCS Istituto Regina Elena Oncologia Medica 1 PHASE 2,Roma,Italy,144[135]Azienda Ospedaliera Santa Maria di Terni - PHASE 2,Terni,Italy,5100[136]Nagoya University Hospital PHASE 2,Nagoya-shi,Aichi,Japan,466-8560[137]National Cancer Center Hospital East PHASE 2,Kashiwa,Chiba,Japan,277-8577[138]Ehime University PHASE 2,Toon-shi,Ehime,Japan,791-0295[139]Hokkaido University Hospital PHASE 2,Sapporo-shi,Hokkaido,Japan,060-8648[140]Kanagawa Cancer Center, Yokohama PHASE 2,Yokohama-shi,Kanagawa,Japan,241-8515[141]Osaka City General Hospital PHASE 2,Osaka-shi,Osaka,Japan,534-0021[142]Osaka International Cancer Institute PHASE 2,Osaka-shi,Osaka,Japan,541-8567[143]National Cancer Center Hospital, Tokyo PHASE 2,Chuo-ku,Tokyo,Japan,104-0045[144]Tottori University Hospital PHASE 2,Yonago-shi,Tottori,Japan,683-8504[145]Chungbuk National University Hospital PHASE 2,Cheongju-si,Chungcheongbuk-do,Korea, Republic of,28644[146]Chonnam National University Hwasun Hospital PHASE 2,Hwasun,Jeollanam-do,Korea, Republic of,58128[147]Seoul National University Hospital PHASE 2,Seoul,Korea, Republic of,03080[148]Konkuk University Medical Center PHASE 2,Seoul,Korea, Republic of,05030[149]Asan Medical Center PHASE 2,Seoul,Korea, Republic of,05505[150]Samsung Medical Center PHASE 2,Seoul,Korea, Republic of,06351[151]Seoul Saint Mary''s Hospital PHASE 2,Seoul,Korea, Republic of,06591[152]Seoul National University Hospital PHASE 1 (recruiting) and PHASE 2 (not yet recruiting),Seoul,Korea, Republic of,110-744[153]Yonsei Cancer Center, Severance Hospital PHASE 1 (recruiting) & PHASE 2 (recruiting),Seoul,Korea, Republic of,120-752[154]Samsung Medical Center PHASE 1,Seoul,Korea, Republic of,135-710[155]Netherlands Cancer Institute PHASE 2,Amsterdam,Netherlands,1066 CX[156]Universiair Medisch Centrum Groningen PHASE 2,Groningen,Netherlands,9713 GZ[157]Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radioterapii PHASE 2,Gdańsk,Poland,80-214[158]Katedra I Klinika Pneumonologii, Onkologii I Alergologii Uniwersytetu Medycznego w Lublinie PHASE 2,Lublin,Poland,20-609[159]Med Polonia, ul. Obornicka PHASE 2,Poznan,Poland,60693[160]Centrum Medyczne Dom Lekarski PHASE 2,Szczecin,Poland,70784[161]Maria Sklodowska-Curie Cancer Centre and Institute PHASE 2,Warszawa,Poland,02-781[162]National University Hospital PHASE 2,Singapore,Central Singapore,Singapore,119704[163]National Cancer Center Singapore PHASE 2,Singapore,Central Singapore,Singapore,169610[164]Clinica Universidad de Navarra PHASE 2,Pamplona,Navarra,Spain,31008[165]Hospital Universitario Dexeus - Grupo Quironsalud PHASE 2,Barcelona,Spain,08028[166]Vall d''Hebron University Hospital PHASE 2,Barcelona,Spain,08035[167]Fundacion MD Anderson PHASE 2,Madrid,Spain,28033[168]START Madrid-FJD PHASE 2,Madrid,Spain,28040[169]Hospital Universitario 12 de Octubre PHASE 2,Madrid,Spain,28041[170]Hospital HM Sanchinarro PHASE 2,Madrid,Spain,28050[171]Instituto Valenciano de Oncología PHASE 2,Valencia,Spain,46009[172]National Cheng Kung University Hospital PHASE 2,Tainan,Taiwan,704[173]National Taiwan University Hospital PHASE 2,Taipei,Taiwan,100[174]Mackay Memorial Hospital PHASE 2,Taipei,Taiwan[175]The Royal Marsden NHS Foundation Trust PHASE 2,London,United Kingdom,SW3 6JJ[176]Imperial College London - Hammersmith Hospital PHASE 2,London,United Kingdom,W12 0HS[177]Sarah Cannon Research Institute PHASE 2,London,United Kingdom,W1G 6AD[178]The Christie NHS Foundation Trust PHASE 2,Manchester,United Kingdom,M20 4BX
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
