LASER – 177Lu-PSMA-617 作为肾细胞癌全身疗法的 II 期试验 (NCT06964958).pdf

1、LASER a Phase 2 trial of 177Lu-PSMA-617 as Systemic Therapy for Renal Cell CarcinomaPraful Ravi,Wanling Xie,Stephanie Berg,Michael Serzan,Bicky Thapa,Srinivas Viswanathan,Wenxin Xu,Bradley McGregor,Toni Choueiri,Heather JaceneDana-Farber Cancer Institute,Boston,MABackground&RationaleEXCLUSION ZONE N

2、ew therapeutic targets are needed in ccRCC PSMA is present on neovasculature of many solid tumors,including ccRCC Confirmed by IHC and RNAseq Can be imaged by PSMA-PET/CT 177Lu-PSMA-617 has proven activity in PSMA-positive prostate cancer,and is well-toleratedOvruchesky et al,Cancer 2024;Sadaghiani

3、et al,J Nuc Med 2024Trial DesignSingle-center ISTAdvanced ccRCC with 1 prior IO and 1 prior TKI1 PSMA-avid lesion and no PSMA-negative lesions2 cycles iPET up to 4 more cyclesIf 1 response in first 9 pts 15 more pts enrolled(total N=24)Primary endpoint:Objective response rate(RECIST)Target ORR of 25

4、%Vision&Impact One of the first PSMA-RLT studies in RCC Potential new target and class of drug in this disease Opportunity to evaluate combinations Promising activity could lead to a larger randomized study Embedded imaging,tissue and blood-based correlatives Insights into mechanisms of response/resistance to RLT in RCC Interplay between immune milieu and response to RLT Inform future RLT efforts in RCC