一项1期试验(NCT05029882)的数据显示,靶向c-Met的新型ADC药物ABBV-400在BRAF野生型、微卫星稳定型(MSS)/错配修复良好型(pMMR)晚期结直肠癌(CRC)患者中显示出初步的抗肿瘤活性,且患者耐受性良好。港安健康国际医疗介绍,ABBV-400将c-Met靶向抗体telisotuzumab与拓扑异构酶1抑制剂有效载荷相结合。c-Met的过表达在...
Part4:ABBV-400单药,未携带BRAF V600E突变和dMMR+/MSI-Hi晚期CRC; Part5:ABBV-400单药,MET扩增,不限癌种; Part6:ABBV-400单药,MET突变,不腺癌种; Part7:ABBV-399联合贝伐珠单抗,结直肠癌CRC; Part8:ABBV-399联合贝伐珠单抗或曲氟尿苷替匹嘧啶(TA...
在2.4 mg/kg和3.0 mg/kg剂量下,ABBV-400在CRC患者中显示出良好的抗肿瘤活性,同时具有可接受的安全性和可控的副作用。 中国上市:近日,国家药品监督管理局药品审评中心(CDE)正式将艾伯维临床研发阶段的输注用无菌冻干粉Telisotuzumab Vedotin(Teliso-V)纳入突破性治疗药物品种名单,拟用于治疗在铂类药物治疗期间或治...
在剂量扩增期间,CRC患者被随机分配接受ABBV-400,剂量分别为1.6mg/kg、2.4mg/kg或3.0mg/kg,每3周一次,以优化剂量并确定第二阶段推荐剂量(RP2D)。 试验的主要终点是评估ABBV-400单药治疗的安 全性、耐受性和药代动力学;获得初步的抗肿瘤活性,包括ORR、CBR、DOR、无进展生存期(PFS)和总生存期;以及确定RP2D。港...
There are no approved therapies specific for c-Met–overexpressing tumors in CRC. The antibody-drug conjugate ABBV-400 comprises c-Met–targeting antibody telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload. A phase 1 study of ABBV-400 was initiated for adults with advanced ...
ABBV-400 conjugate average concentration was a better predictor of response and showed that higher exposure correlated with higher probability of response (n=122 CRC, ORR, p < 0.05) and safety events (n=204, Gr 鈮 3 neutropenia, anemia and thrombocytopenia, p < 0.001). Dose intensity ...
c-Met overexpression frequently occurs in a variety of tumors, including CRC. ABBV-400 is a c-Met–directed antibody-drug conjugate composed of the monoclonal antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. Preliminary data from the first-in-human study of ABBV-...