SHR-A1904, CLDN18.2-Targeting ADC, Ikuwonetsa Ntchito Yolimbana ndi Chotupa mu Khansa Yapamwamba ya M'mimba/Gastroesophageal Junction: Zotsatira za Mayeso a Gawo 1

Pa Julayi 16, magazini yapamwamba yapadziko lonse ya Nature Medicine inafalitsa deta yofufuza za SHR-A1904, mankhwala opha tizilombo toyambitsa matenda (ADC) omwe amagwiritsidwa ntchito pochiza claudin 18.2 (CLDN18.2), pochiza khansa ya m'mimba yoopsa kapena khansa ya m'mimba yolumikizana (GC/GEJC). Ofufuzawo adachita kafukufuku woyamba wa Gawo 1 mwa anthu, wa magawo atatu, kuti awone momwe SHR-A1904 imagwirira ntchito mwa odwala 95 omwe adachiritsidwa kale ndi khansa ya CLDN18.2-positive G/GEJ.​

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Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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Claudin-18 isoform 2 (CLDN18.2), puloteni yolumikizana yomwe imaonekera mu epithelium ya m'mimba yopanda matenda ndipo imaonekera pamwamba pa maselo a chotupa panthawi yosintha kwa khansa, ndi njira yabwino kwambiri yothandizira khansa ya m'mimba ndi m'mimba (G/GEJ). SHR-A1904 ndi cholumikizira cha antibody-drug chomwe chili ndi CLDN18.2-target monoclonal antibody, DNA topoisomerase I inhibitor payload ndi cleavable peptide-based linker.

Mu gawo lokwera kwa mlingo (0.6–8.0 mg kg−1), poizoni wochepetsa mlingo unawonedwa mwa odwala awiri omwe anali ndi 4.8 mg kg−1 (febrile neutropenia ya giredi 3 ndi kuchuluka kwa bilirubin m'magazi a giredi 3) ndi wodwala m'modzi omwe anali ndi 6.0 mg kg−1 (chilonda cha mucosal cha giredi 3). Mlingo wapamwamba kwambiri womwe unaloledwa sunafike, ndipo 6.0 mg kg−1 ndi 8.0 mg kg−1 adasankhidwa kuti awonjezere mankhwala ndi mphamvu. Zochitika zoyipa zomwe zidachitika mwadzidzidzi pa chithandizo zidachitika mwa odwala onse 95, makamaka kuchepa kwa magazi m'thupi (72 (75.8%)), nseru (64 (67.4%), hypoalbuminemia (61 (64.2%)) ndi kuchepa kwa kuchuluka kwa maselo oyera m'magazi (56 (58.9%)). Kuphatikiza apo, odwala 59 (62.1%) adakumana ndi zovuta zokhudzana ndi mankhwala a giredi 3 kapena kupitirira apo. Palibe imfa zokhudzana ndi chithandizo zomwe zidanenedwa. Pakati pa odwala omwe adayesedwa kuti alandire chithandizo, kuchuluka kwa mayankho otsimikizika omwe adatsimikizika anali 24.2% (95% nthawi yodzidalira (CI), 11.1–42.3) pa 6.0 mg kg−1 ndi 25.0% (95% CI, 12.1–42.2) pa 8.0 mg kg−1. Kupulumuka kwapakati popanda kupita patsogolo kunali miyezi 5.6 (95% CI, 3.0–6.9) pa 6.0 mg kg−1 ndi miyezi 5.8 (95% CI, 3.0–8.6) pa 8.0 mg kg−1. Pomaliza, SHR-A1904 idawonetsa chitetezo chodalirika komanso kulimbikitsa ntchito yolimbana ndi chotupa mwa odwala omwe ali ndi khansa ya CLDN18.2-positive G/GEJ, zomwe zikufunika kufufuza kwina.

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Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

Nambala ya Foni: 4008803716

Chizindikiro cha WeChat: 17801183037

Email:myimmnet@163.com

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Nthawi yotumizira: Julayi-24-2025