Ngomhlaka-16 kuJulayi, iphephabhuku lomhlaba wonke elihamba phambili i-Nature Medicine lashicilela idatha yocwaningo nge-SHR-A1904, i-antibody-drug conjugate (ADC) ehlose i-claudin 18.2 (CLDN18.2), yokwelapha umdlavuza wesisu osezingeni eliphezulu noma umdlavuza we-gastroesophageal junction (GC/GEJC). Abacwaningi benze isivivinyo somtholampilo sokuqala esisebantwini, esinezigaba ezintathu, seSigaba 1 ukuhlola ukusebenza kahle kwe-SHR-A1904 ezigulini ezingu-95 ezelashwe ngaphambilini ezinomdlavuza we-G/GEJ osezingeni eliphezulu we-CLDN18.2.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
I-Claudin-18 isoform 2 (CLDN18.2), iphrotheni ehlanganisiwe ebonakala ku-epithelium yesisu engalimazanga futhi ivezwe ebusweni beseli lesimila ngesikhathi sokuguqulwa okulimazayo, iyisithako esithembisayo sokwelapha umdlavuza wesisu kanye ne-gastroesophageal junction (G/GEJ). I-SHR-A1904 iyi-antibody-drug conjugate equkethe i-CLDN18.2-targeting monoclonal antibody, i-DNA topoisomerase I inhibitor payload kanye ne-linker esuselwe ku-peptide eqhekekayo.
Esigabeni sokwanda komthamo (0.6–8.0 mg kg−1), ubuthi obukhawulela umthamo bubonwe ezigulini ezimbili ku-4.8 mg kg−1 (i-neutropenia yezinga lesi-3 enomkhuhlane kanye ne-bilirubin yegazi eyandayo yebanga lesi-3) kanye nesiguli esisodwa ku-6.0 mg kg−1 (isilonda sesisu sebanga lesi-3). Umthamo omkhulu obekezelelwe awuzange ufinyelelwe, kanti u-6.0 mg kg−1 kanye no-8.0 mg kg−1 bakhethwa ukuze kukhuliswe i-pharmacokinetic kanye nokusebenza kahle. Izehlakalo ezimbi ezivelela ukwelashwa zenzeka kuzo zonke iziguli ezingu-95, ikakhulukazi i-anemia (72 (75.8%)), isicanucanu (64 (67.4%)), i-hypoalbuminemia (61 (64.2%) kanye nokwehla kwenani lamaseli amhlophe egazi (56 (58.9%)). Ngaphezu kwalokho, iziguli ezingu-59 (62.1%) zithole izehlakalo ezimbi ezihlobene nemithi zebanga lesi-3 noma ngaphezulu. Azikho izehlakalo ezibikiwe ezihlobene nokwelashwa. Phakathi kweziguli ezihlolwa impendulo, izinga lokuphendula eliqinisekisiwe eliqondile lalingu-24.2% (95% isikhathi sokuzethemba (CI), 11.1–42.3) ku-6.0 mg kg−1 kanye no-25.0% (95% CI, 12.1–42.2) ku-8.0 mg kg−1. Ukusinda okuphakathi nendawo okungenalo ukuqhubekela phambili kwakuyizinyanga ezingu-5.6 (95% CI, 3.0–6.9) ku-6.0 mg kg−1 kanye nezinyanga ezingu-5.8 (95% CI, 3.0–8.6) ku-8.0 mg kg−1. Ekuphetheni, i-SHR-A1904 ibonise iphrofayili yokuphepha elawulekayo futhi ikhuthaza umsebenzi wokulwa nomdlavuza ezigulini ezinomdlavuza we-G/GEJ one-CLDN18.2, odinga uphenyo olwengeziwe.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Julayi-24-2025