Musi wa16 Chikunguru, magazini yepamusoro-soro yepasi rose inonzi Nature Medicine yakaburitsa ruzivo rwekutsvagisa nezveSHR-A1904, mushonga unodzivirira zvirwere (ADC) unoshandiswa pakurapa claudin 18.2 (CLDN18.2), wekurapa kenza yemudumbu yakakwira kana kenza yemudumbu (GC/GEJC). Vatsvagurudzi vakaita bvunzo yekutanga yekiriniki yePhase 1 muvanhu, ine matanho matatu, kuti vaongorore kushanda kweSHR-A1904 muvarwere 95 vakamborapwa nekenza yeG/GEJ ine CLDN18.2-positive.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Claudin-18 isoform 2 (CLDN18.2), protein ine tight junction inowanikwa mu epithelium yemudumbu isingauraye uye inoonekwa pamusoro pemasero egomarara panguva yekuchinja kwemasero egomarara, inyanzvi yekurapa kenza yemudumbu neyegastroesophageal junction (G/GEJ). SHR-A1904 iantibody-drug conjugate ine CLDN18.2-targeting monoclonal antibody, DNA topoisomerase I inhibitor payload uye cleavable peptide-based linker.
Muchikamu chekukwira kwemuyero (0.6–8.0 mg kg−1), chepfu dzinoderedza muyero dzakaonekwa muvarwere vaviri pa4.8 mg kg−1 (febrile neutropenia yegiredhi rechitatu uye kuwedzera kwebilirubin muropa yegiredhi rechitatu) uye mumurwere mumwe chete pa6.0 mg kg−1 (gastric mucosal lesion yegiredhi rechitatu). Muyero wepamusoro wakabvumidzwa hauna kusvikwa, uye 6.0 mg kg−1 uye 8.0 mg kg−1 zvakasarudzwa kuti zviwedzere pharmacokinetic uye efficiency. Zviitiko zvisina kunaka zvekurapa zvakaitika muvarwere vese 95, kazhinji anemia (72 (75.8%)), kuda kurutsa (64 (67.4%), hypoalbuminemia (61 (64.2%) uye kudzikira kwehuwandu hwemasero machena eropa (56 (58.9%)). Pamusoro pezvo, varwere 59 (62.1%) vakasangana nezviitiko zvisina kunaka zvine chekuita nemishonga yegiredhi rechitatu kana kupfuura. Hapana rufu rwakakonzerwa nekurapwa rwakataurwa. Pakati pevarwere vakaongororwa, chiyero chekupindura chakasimbiswa chaive 24.2% (95% confidence interval (CI), 11.1–42.3) pa6.0 mg kg−1 uye 25.0% (95% CI, 12.1–42.2) pa8.0 mg kg−1. Avhareji yekurarama pasina kufambira mberi yaive mwedzi 5.6 (95% CI, 3.0–6.9) pa6.0 mg kg−1 uye mwedzi 5.8 (95% CI, 3.0–8.6) pa8.0 mg kg−1. Mukupedzisa, SHR-A1904 yakaratidza kuchengetedzeka kunogoneka uye kukurudzira kushanda kwekudzivirira bundu muvarwere vane CLDN18.2-positive G/GEJ cancer, zvichireva kuti kuongororwa kwakawanda kwaizoitwa.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Nguva yekutumira: Chikunguru-24-2025