Thaum Lub Rau Hli 6, phau ntawv xov xwm kho mob thoob ntiaj teb Journal of Hematology & Oncology tau tshaj tawm cov txiaj ntsig ntawm kev tshawb fawb theem I/II (KL264-01/MK-2870-001) ntawm TROP2 ADC sacituzumab tirumotecan (sac-TMT) tshiab ua kev kho mob ib leeg rau cov qog nqaij hlav uas tsis tuaj yeem phais tau lossis cov qog nqaij hlav metastatic uas tsis kho tau rau cov kev kho mob ib txwm muaj.
Sacituzumab tirumotecan (sac-TMT) yog ib qho tshuaj antibody-drug conjugate uas muaj ib qho anti-TROP2 monoclonal antibody txuas nrog ib qho cytotoxic belotecan-derived topoisomerase I inhibitor (KL610023) ntawm ib qho txuas tshiab.
Cov txheej txheem
Cov neeg mob muaj cov qog nqaij hlav hauv zos uas tsis tuaj yeem phais tau thiab tsis kho tau raws li cov kev kho mob ib txwm muaj. Hauv cov pawg neeg mob uas nce koob tshuaj theem 1, cov neeg mob muaj cov qog nqaij hlav hauv zos uas tsis tuaj yeem phais tau thiab tsis kho tau raws li cov kev kho mob ib txwm muaj. Sac-TMT tau muab los ntawm kev txhaj tshuaj rau hauv cov hlab ntsha txhua 2 lub lis piam ntawm 2 txog 12 mg/kg. Hauv theem 2, cov neeg mob uas muaj mob qog nqaij hlav hauv lub mis TNBC thiab HR+/HER2− tau txais sac-TMT raws li cov koob tshuaj pom zoo rau kev nthuav dav (RDEs) uas tau txheeb xyuas hauv theem 1. Lub hom phiaj tseem ceeb yog txiav txim siab qhov koob tshuaj siab tshaj plaws uas zam tau (MTD) ntawm sac-TMT thiab tsim RDEs (theem 1) thiab txiav txim siab ORR ib RECIST v1.1 los ntawm kev ntsuam xyuas ntawm tus kws tshawb nrhiav (theem 2). Cov xwm txheej tsis zoo tau raug soj ntsuam raws li NCI-CTCAE version 5.0.
Cov txiaj ntsig
Peb caug tus neeg mob tau raug sau npe rau theem 1 thiab tau txais sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), thiab 6 mg/kg (n = 7). Tsib tus neeg mob muaj kev lom tshuaj uas txwv tsis pub noj: mob qhov ncauj theem 3 ntawm 4, 5.5, thiab 6 mg/kg; mob pob khaus theem 3 ntawm 5 mg/kg; thiab mob urticaria theem 3 ntawm 6 mg/kg. MTD yog 5.5 mg/kg thiab RDEs yog 4 thiab 5 mg/kg. Hauv theem 2 koob tshuaj nthuav dav, ORR (95% CI) yog 34.8% (16.4%, 57.3%) hauv pawg 4-mg/kg (n = 23) thiab 38.9% (23.1%, 56.5%) hauv pawg 5-mg/kg (n = 36) rau TNBC. ORR (95% CI) yog 31.7% (18.1%, 48.1%) rau mob qog noj ntshav hauv lub mis HR+/HER2− (n = 41).
Cov Lus Xaus
Sac-TMT tau ua pov thawj tias muaj kev nyab xeeb rau cov neeg mob uas muaj cov qog nqaij hlav uas tsis tuaj yeem phais tau thiab muaj kev ua haujlwm tiv thaiv qog nqaij hlav hauv TNBC thiab HR+/HER2 − mob qog nqaij hlav mis uas kis mus rau lwm qhov. Sac-TMT tab tom raug tshawb nrhiav hauv kev tshawb fawb theem 3.
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.
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Lub sijhawm tshaj tawm: Lub Rau Hli-19-2025