Thaum Lub Xya Hli 16, phau ntawv xov xwm thoob ntiaj teb zoo tshaj plaws Nature Medicine tau tshaj tawm cov ntaub ntawv tshawb fawb txog SHR-A1904, ib qho tshuaj antibody-drug conjugate (ADC) uas tsom mus rau claudin 18.2 (CLDN18.2), rau kev kho mob qog nqaij hlav plab lossis qog nqaij hlav gastroesophageal junction (GC/GEJC). Cov kws tshawb fawb tau ua thawj zaug hauv tib neeg, peb theem, Theem 1 kev sim tshuaj los ntsuas qhov ua tau zoo ntawm SHR-A1904 hauv 95 tus neeg mob uas tau kho mob yav dhau los uas muaj CLDN18.2-zoo qog nqaij hlav G/GEJ.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Claudin-18 isoform 2 (CLDN18.2), ib qho protein sib txuas nruj uas qhia tawm hauv cov epithelium gastric uas tsis yog malignant thiab raug rau ntawm qhov chaw ntawm cov qog nqaij hlav thaum lub sijhawm hloov pauv malignant, yog lub hom phiaj kho mob zoo rau cov qog nqaij hlav gastric thiab gastroesophageal junction (G/GEJ). SHR-A1904 yog ib qho antibody-drug conjugate uas muaj CLDN18.2-targeting monoclonal antibody, ib qho DNA topoisomerase I inhibitor payload thiab ib qho cleavable peptide-based linker.
Nyob rau theem ntawm kev nce koob tshuaj (0.6–8.0 mg kg−1), cov tshuaj lom uas txwv tsis pub siv tau pom nyob rau hauv ob tus neeg mob ntawm 4.8 mg kg−1 (qib 3 febrile neutropenia thiab qib 3 nce cov ntshav bilirubin) thiab hauv ib tus neeg mob ntawm 6.0 mg kg−1 (qib 3 gastric mucosal lesion). Tsis tau txog qhov siab tshaj plaws ntawm cov tshuaj uas kam rau siab, thiab 6.0 mg kg−1 thiab 8.0 mg kg−1 tau raug xaiv rau kev nthuav dav pharmacokinetic thiab kev ua haujlwm zoo. Cov xwm txheej tsis zoo ntawm kev kho mob tshwm sim rau tag nrho 95 tus neeg mob, feem ntau yog anemia (72 (75.8%)), xeev siab (64 (67.4%), hypoalbuminemia (61 (64.2%)) thiab txo cov qe ntshav dawb (56 (58.9%)). Tsis tas li ntawd, 59 tus neeg mob (62.1%) tau ntsib cov xwm txheej tsis zoo ntawm qib 3 lossis siab dua ntawm kev siv tshuaj. Tsis muaj kev tuag ntsig txog kev kho mob tau tshaj tawm. Ntawm cov neeg mob uas tau ntsuam xyuas cov lus teb, qhov feem pua lus teb tau lees paub yog 24.2% (95% kev ntseeg siab (CI), 11.1–42.3) ntawm 6.0 mg kg−1 thiab 25.0% (95% CI, 12.1–42.2) ntawm 8.0 mg kg−1. Qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib yog 5.6 lub hlis (95% CI, 3.0–6.9) ntawm 6.0 mg kg−1 thiab 5.8 lub hlis (95% CI, 3.0–8.6) ntawm 8.0 mg kg−1. Xaus lus, SHR-A1904 tau ua pov thawj txog kev nyab xeeb thiab txhawb kev ua haujlwm tiv thaiv qog hauv cov neeg mob uas muaj mob qog noj ntshav G/GEJ CLDN18.2-zoo, uas tsim nyog tshawb nrhiav ntxiv.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Lub sijhawm tshaj tawm: Lub Xya Hli-24-2025