{"id":"https://openalex.org/W4286299173","doi":"https://doi.org/10.1200/jco.2022.40.16_suppl.e14560","title":"A phase 1 study of serplulimab, a novel humanized monoclonal anti-PD-1 antibody, in patients with advanced solid tumors.","display_name":"A phase 1 study of serplulimab, a novel humanized monoclonal anti-PD-1 antibody, in patients with advanced solid tumors.","publication_year":2022,"publication_date":"2022-06-01","ids":{"openalex":"https://openalex.org/W4286299173","doi":"https://doi.org/10.1200/jco.2022.40.16_suppl.e14560"},"language":"en","primary_location":{"id":"doi:10.1200/jco.2022.40.16_suppl.e14560","doi":"https://doi.org/10.1200/jco.2022.40.16_suppl.e14560","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2022.40.16_suppl.e14560","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","is_traditional":false,"indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5110361957","display_name":"Ching-Liang Ho","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1293718874","display_name":"Tri-Service General Hospital","ror":"https://ror.org/007h4qe29","country_code":"TW","type":"healthcare","lineage":["https://openalex.org/I1293718874"]},{"id":"https://openalex.org/I68171755","display_name":"National Defense Medical Center","ror":"https://ror.org/02bn97g32","country_code":"TW","type":"healthcare","lineage":["https://openalex.org/I68171755"]}],"countries":["TW"],"is_corresponding":false,"raw_author_name":"Ching-Liang Ho","raw_affiliation_strings":["Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan;","institution_ids":["https://openalex.org/I1293718874","https://openalex.org/I68171755"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5088731206","display_name":"Tsu\u2010Yi Chao","orcid":"https://orcid.org/0000-0002-2850-5137","observed_orcids":["https://orcid.org/0000-0002-2850-5137"]},"institutions":[{"id":"https://openalex.org/I4210121532","display_name":"Ministry of Health and Welfare","ror":"https://ror.org/024w0ge69","country_code":"TW","type":"government","lineage":["https://openalex.org/I4210121532","https://openalex.org/I4405257903"]},{"id":"https://openalex.org/I4210158385","display_name":"Taipei Medical University-Shuang Ho Hospital","ror":"https://ror.org/04k9dce70","country_code":"TW","type":"healthcare","lineage":["https://openalex.org/I4210158385"]},{"id":"https://openalex.org/I47519274","display_name":"Taipei Medical University","ror":"https://ror.org/05031qk94","country_code":"TW","type":"education","lineage":["https://openalex.org/I47519274"]}],"countries":["TW"],"is_corresponding":false,"raw_author_name":"Tsu-Yi Chao","raw_affiliation_strings":["Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare, Taipei, Taiwan;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare, Taipei, Taiwan;","institution_ids":["https://openalex.org/I4210121532","https://openalex.org/I4210158385","https://openalex.org/I47519274"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5102311421","display_name":"Chia lun Chang","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210142271","display_name":"Wan Fang Hospital","ror":"https://ror.org/058y0nn10","country_code":"TW","type":"healthcare","lineage":["https://openalex.org/I4210142271"]}],"countries":["TW"],"is_corresponding":false,"raw_author_name":"Chia lun Chang","raw_affiliation_strings":["Taipei Municipal Wanfang Hospital, Taipei, Taiwan;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Taipei Municipal Wanfang Hospital, Taipei, Taiwan;","institution_ids":["https://openalex.org/I4210142271"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5102766022","display_name":"Hsuan-Yu Lin","orcid":"https://orcid.org/0000-0002-2570-5379","observed_orcids":["https://orcid.org/0000-0002-2570-5379"]},"institutions":[{"id":"https://openalex.org/I4210159511","display_name":"Changhua Christian Hospital","ror":"https://ror.org/05d9dtr71","country_code":"TW","type":"healthcare","lineage":["https://openalex.org/I4210159511"]}],"countries":["TW"],"is_corresponding":false,"raw_author_name":"Hsuan-Yu Lin","raw_affiliation_strings":["Changhua Christian Hospital, Changhua, Taiwan;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Changhua Christian Hospital, Changhua, Taiwan;","institution_ids":["https://openalex.org/I4210159511"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5047118710","display_name":"Futang Yang","orcid":"https://orcid.org/0009-0003-4559-8608","observed_orcids":["https://orcid.org/0009-0003-4559-8608"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Futang Yang","raw_affiliation_strings":["Shanghai Henlius Biotech, Inc., Shanghai, China;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Shanghai Henlius Biotech, Inc., Shanghai, China;","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5115694881","display_name":"Qingyu Wang","orcid":"https://orcid.org/0009-0005-2716-611X","observed_orcids":["https://orcid.org/0009-0005-2716-611X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Qingyu Wang","raw_affiliation_strings":["Shanghai Henlius Biotech, Inc., Shanghai, China;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Shanghai Henlius Biotech, Inc., Shanghai, China;","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5102023700","display_name":"Jun Zhu","orcid":"https://orcid.org/0000-0003-4372-4546","observed_orcids":["https://orcid.org/0000-0003-4372-4546"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Jun Zhu","raw_affiliation_strings":["Shanghai Henlius Biotech, Inc., Shanghai, China;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Shanghai Henlius Biotech, Inc., Shanghai, China;","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":7,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"40","issue":"16_suppl","first_page":"e14560","last_page":"e14560"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10158","display_name":"Cancer Immunotherapy and Biomarkers","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10158","display_name":"Cancer Immunotherapy and Biomarkers","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10580","display_name":"Immunotherapy and Immune Responses","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10031","display_name":"T-cell and B-cell Immunology","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/serplulimab","display_name":"serplulimab","score":0.9980000257492065},{"id":"https://openalex.org/keywords/anti-pd-1-antibody","display_name":"anti-PD-1","score":0.8859999775886536},{"id":"https://openalex.org/keywords/humanized-antibody","display_name":"humanized monoclonal antibody","score":0.8610000014305115},{"id":"https://openalex.org/keywords/metastatic-solid-tumors","display_name":"metastatic solid tumors","score":0.7929999828338623},{"id":"https://openalex.org/keywords/recurrent-solid-tumors","display_name":"recurrent solid tumors","score":0.8450000286102295},{"id":"https://openalex.org/keywords/maximum-tolerated-dose","display_name":"maximum tolerated dose","score":0.8529999852180481},{"id":"https://openalex.org/keywords/dose-limiting-toxicity","display_name":"dose-limiting toxicity","score":0.9350000023841858},{"id":"https://openalex.org/keywords/safety-and-tolerability","display_name":"safety and tolerability","score":0.7789999842643738},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.9480000138282776},{"id":"https://openalex.org/keywords/bayesian-optimal-interval-design","display_name":"Bayesian optimal interval design","score":0.7450000047683716},{"id":"https://openalex.org/keywords/immune-checkpoint-inhibitors","display_name":"immune checkpoint inhibitors","score":0.5830000042915344},{"id":"https://openalex.org/keywords/pd-1-receptor","display_name":"PD-1 receptor","score":0.5120000243186951},{"id":"https://openalex.org/keywords/anti-drug-antibodies","display_name":"anti-drug antibodies","score":0.5410000085830688}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9178214073181152},{"id":"https://openalex.org/C72563966","wikidata":"https://www.wikidata.org/wiki/Q1303415","display_name":"Cohort","level":2,"score":0.7627840042114258},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.7358472943305969},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.5269758701324463},{"id":"https://openalex.org/C159654299","wikidata":"https://www.wikidata.org/wiki/Q79460","display_name":"Antibody","level":2,"score":0.4533521234989166},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.38004574179649353},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.3727417588233948},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.3726244866847992},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.36553120613098145},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.17439350485801697}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1200/jco.2022.40.16_suppl.e14560","doi":"https://doi.org/10.1200/jco.2022.40.16_suppl.e14560","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2022.40.16_suppl.e14560","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":1.0,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4410803798","https://openalex.org/W4390729674","https://openalex.org/W4282046381","https://openalex.org/W3011361209","https://openalex.org/W4306770612","https://openalex.org/W2890844400","https://openalex.org/W4284884589","https://openalex.org/W4206694122","https://openalex.org/W4411394987","https://openalex.org/W2898464548"],"abstract_inverted_index":{"e14560":[0],"Background:":[1],"Serplulimab,":[2],"a":[3,260,266,273,391,400],"novel":[4],"humanized":[5],"IgG4":[6],"monoclonal":[7],"antibody":[8],"against":[9],"PD-1":[10],"receptor,":[11],"increased":[12],"functional":[13],"activities":[14],"of":[15,39,100,109,124,154,168,180,207,222,253,263,269,276,332,351,374,386,393,397,403],"human":[16],"T":[17],"cells":[18],"and":[19,37,177,185,215,272,368,399,417],"showed":[20,418],"anti-tumor":[21,384,420],"activity":[22,421],"in":[23,41,72,146,298,422,435],"several":[24],"xenograft":[25],"models.":[26],"This":[27,50],"phase":[28,67,436],"1":[29,68,125,230,334],"study":[30,69,170],"was":[31,70,94,171,256,307,315,358,376,388,414],"designed":[32],"to":[33,57,64,96,150,172,348,411],"assess":[34],"the":[35,86,98,122,129,137,174,178,186,200,203,250,299,310,329,343,349],"safety":[36,175],"tolerability":[38],"serplulimab":[40,105,155,223,375,387,409],"patients":[42,73,143,212,255,279,322,423,440],"with":[43,74,217,259,281,292,346,424,441],"metastatic":[44,75,293,425],"or":[45,76,113,131,161,335,426],"recurrent":[46,77,427],"solid":[47,78,428],"tumors.":[48,429],"Methods:":[49],"prospective,":[51],"open-label,":[52],"two-cohort":[53],"(dose-finding":[54],"cohort":[55,62],"[up":[56,63],"30":[58],"patients];":[59],"dose":[60,138,148,221,302,344,380],"expansion":[61,139],"27":[65],"patients])":[66],"conducted":[71],"tumors":[79,284],"who":[80],"had":[81],"failed":[82],"standard":[83],"therapy.":[84],"In":[85,136,407],"dose-finding":[87,204],"cohort,":[88,140],"Bayesian":[89],"optimal":[90],"interval":[91],"(BOIN)":[92],"design":[93],"adopted":[95],"explore":[97],"MTD":[99,179,314],"serplulimab.":[101,181],"Patients":[102],"were":[103,144,189,213,290,340],"administered":[104],"(Q2W)":[106],"at":[107,156,218,285,324],"doses":[108,153],"0.3,":[110],"1,":[111],"3,":[112],"10":[114,242,412],"mg/kg":[115,225,231,237,243,301,413],"via":[116],"intravenous":[117],"infusion":[118],"until":[119],"disease":[120],"progression,":[121],"maximum":[123],"year,":[126],"withdrawal":[127],"from":[128,202],"study,":[130,330],"death,":[132],"whichever":[133],"occurred":[134],"first.":[135],"nine":[141],"eligible":[142],"enrolled":[145,214,254],"each":[147],"group":[149,303],"receive":[151],"fixed":[152],"200":[157],"(Q2W),":[158],"300":[159],"(Q3W)":[160],"400":[162],"mg":[163],"(Q4W).":[164],"The":[165,182,313,353,382],"primary":[166],"objective":[167],"this":[169],"identify":[173],"profile":[176,184],"PK":[183],"preliminary":[187,383],"efficacy":[188,385],"also":[190],"examined":[191],"as":[192],"secondary":[193],"objectives.":[194],"Results:":[195],"Here":[196],"we":[197],"only":[198],"report":[199],"results":[201],"cohort.":[205],"As":[206],"July":[208],"27,":[209],"2020,":[210],"29":[211],"treated":[216],"least":[219,325],"one":[220,296,326],"(0.3":[224],"group,":[226,232,238,244],"n":[227,233,239,245],"=":[228,234,240,246],"3;":[229],"4;":[235],"3":[236,300,437],"6;":[241],"16).":[247],"At":[248],"baseline,":[249,286],"mean":[251,261,267,274],"age":[252],"60.0":[257],"years,":[258],"BMI":[262],"24.7":[264],"kg/m2,":[265],"BSA":[268],"1.7":[270],"m2,":[271],"LVEF":[275],"67.1%.":[277],"All":[278],"presented":[280],"stage":[282],"IV":[283],"among":[287,342,439],"whom":[288],"79.3%":[289],"diagnosed":[291],"disease.":[294],"Only":[295],"patient":[297],"experienced":[304,323],"DLTs,":[305],"which":[306],"reported":[308,356],"during":[309,328],"first":[311],"cycle.":[312],"not":[316],"determined":[317],"yet.":[318],"Overall,":[319],"28":[320],"(96.6%)":[321],"TEAE":[327],"mostly":[331],"grade":[333],"2.":[336],"No":[337],"notable":[338],"differences":[339],"observed":[341,377],"groups":[345],"regard":[347],"incidence":[350],"TEAEs.":[352],"most":[354],"frequently":[355],"TEAEs":[357],"decreased":[359],"appetite":[360],"(41.4%),":[361],"fatigue":[362],"(31.0%),":[363],"nausea":[364],"(27.6%),":[365,367],"pyrexia":[366],"pleural":[369],"effusion":[370],"(27.6%).":[371],"Minimal":[372],"accumulation":[373],"following":[378],"multiple":[379],"administrations.":[381],"demonstrated":[389],"by":[390],"DCR":[392],"60.0%,":[394],"an":[395],"ORR":[396],"8.0%,":[398],"median":[401],"PFS":[402],"107.0":[404],"days.":[405],"Conclusions:":[406],"summary,":[408],"up":[410],"well":[415],"tolerated":[416],"promising":[419],"Serplulimab":[430],"is":[431],"currently":[432],"being":[433],"investigated":[434],"studies":[438],"NSCLC,":[442],"SCLC,":[443],"esophageal":[444],"cancer,":[445],"mCRC,":[446],"etc.":[447],"Clinical":[448],"trial":[449],"information:":[450],"NCT03468751.":[451]},"counts_by_year":[],"updated_date":"2026-10-01T08:54:57.152042","created_date":"2022-07-21T00:00:00"}