Ngomhla we-16 kweyeKhala, iphephancwadi lehlabathi eliphambili iNature Medicine lapapasha idatha yophando kwi-SHR-A1904, i-antibody-drug conjugate (ADC) ejolise kwi-claudin 18.2 (CLDN18.2), yokunyanga umhlaza wesisu ophucukileyo okanye umhlaza we-gastroesophageal junction (GC/GEJC). Abaphandi benze uvavanyo lweklinikhi lokuqala ebantwini, olunezigaba ezintathu, lweSigaba soku-1 ukuvavanya ukusebenza kakuhle kwe-SHR-A1904 kwizigulana ezingama-95 ezazinyangwe ngaphambili zinomhlaza we-G/GEJ ophucukileyo we-CLDN18.2.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
I-Claudin-18 isoform 2 (CLDN18.2), iprotheyini ye-tight junction ebonakala kwi-epithelium yesisu engeyiyo ebangela umhlaza kwaye ivezwe kumphezulu weseli yethumba ngexesha lokuguqulwa kwe-malignant, yindawo ethembisayo yonyango lwe-gastric and gastroesophageal junction (G/GEJ). I-SHR-A1904 yi-antibody-drug conjugate equka i-CLDN18.2-target monoclonal antibody, i-DNA topoisomerase I inhibitor payload kunye ne-cleavable peptide-based linker.
Kwinqanaba lokunyuka kwedosi (0.6–8.0 mg kg−1), ubuthi obuthintela idosi bubonwe kwizigulana ezibini kwi-4.8 mg kg−1 (i-neutropenia ye-febrile yebanga lesi-3 kunye ne-bilirubin yegazi eyonyukileyo yebanga lesi-3) nakwisigulane esinye kwi-6.0 mg kg−1 (isilonda se-mucosal yebanga lesi-3). Idosi ephezulu evunyelweyo ayifikelelwanga, kwaye i-6.0 mg kg−1 kunye ne-8.0 mg kg−1 zikhethwe ukuze kuphuculwe i-pharmacokinetic kunye nokusebenza kakuhle. Iziganeko ezimbi ezivele ngonyango zenzeke kuzo zonke izigulana ezingama-95, ikakhulu i-anemia (72 (75.8%)), isicaphucaphu (64 (67.4%)), i-hypoalbuminemia (61 (64.2%) kunye nokwehla kwenani leeseli ezimhlophe zegazi (56 (58.9%)). Ukongeza, izigulana ezingama-59 (62.1%) ziye zafumana iziganeko ezimbi ezinxulumene neziyobisi zebanga lesi-3 okanye ngaphezulu. Akukho kufa kuxeliweyo. Phakathi kwezigulane ezivavanywayo, izinga lokuphendula eliqinisekisiweyo yayiyi-24.2% (95% isithuba sokuzithemba (CI), 11.1–42.3) kwi-6.0 mg kg−1 kunye ne-25.0% (95% CI, 12.1–42.2) kwi-8.0 mg kg−1. Ukusinda okuphakathi okungenankqubela phambili yayiyiinyanga ezi-5.6 (95% CI, 3.0–6.9) kwi-6.0 mg kg−1 kunye neenyanga ezi-5.8 (95% CI, 3.0–8.6) kwi-8.0 mg kg−1. Ukuqukumbela, i-SHR-A1904 ibonise iprofayili yokhuseleko elawulekayo kwaye ikhuthaza umsebenzi wokulwa nethumba kwizigulane ezine-CLDN18.2-positive G/GEJ cancer, nto leyo edinga uphando olongezelelweyo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha leposi: Julayi-24-2025