一项评估首创 XmAb819 (ENPP3 x CD3) 在复发或难治性透明细胞肾细胞癌 (ccRCC) 患者中的安全性和耐受性的 1 期多剂量研究 (NCT05433142).pdf

1、A Phase 1 study of XmAb819(ENPP3 x CD3)in subjects with relapsed or refractory clear cell renal cell carcinoma(ccRCC)Ritesh KotechaMemorial Sloan Kettering Cancer CenterProprietary;do not reproduceIntroduction Ectonucleotide pyrophosphatase/phosphodiesterase 3(ENPP3)is differentially expressed in RC

2、C The expression of ENPP3 in normal human tissues is generally low and localized XmAb819 is a humanized,anti-ENPP3 x anti-CD3 bispecific antibody that directs Tcell-mediated cytotoxicity(Figure)The XmAb 2+1 format antibody provides avid tumor targeting and selectivityFigure:XmAb819:2+1 ENPP3 x CD3Bi

3、specific Fc Domainanti-ENPP32 Fabsanti-CD31 scFvTrial DesignDose Escalation:IV and SC CohortsCycle 1Cycle 2Cycle 3ScanScanScanScreeningOngoingThe priming cycle has priming,step-up,and target doses.Each subsequent cycle has target doses.This is a Phase 1,first-in-human study of XmAb819 in patients wi

4、th relapsed or refractory ccRCC measurable by RECIST 1.1 The study is planned to enroll globallyPrimingVisionStudy ObjectivesPrimarySafety and tolerabilityIdentify recommended dosesSecondaryPharmacokinetics Antitumor activityExploratoryPeripheral pharmacodynamicsENPP3 expressionDetermine recommended dose&open expansion to enroll ccRCC and other solid tumors expressing ENPP3,including papillary RCC