Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma
brief summary
To learn if sacituzumab tirumotecan can help to control advanced or metastatic SMARCB1-deficient RMC in patients whose disease has progressed after receiving at least 1 treatment.
detailed description
Primary Objectives
To determine the objective response rate (ORR) at any time and disease control rate (DCR) through 18 weeks from treatment initiation, as assessed by independent reviewer per RECIST 1.1, of sacituzumab tirumotecan in participants with locally advanced or metastatic SMARCB1-deficient RMC who have progressed on at least one prior line of therapy.
Secondary Objectives
To determine the efficacy and safety of sacituzumab tirumotecan in participants with locally advanced or metastatic SMARCB1-deficient RMC who have progressed on at least one prior line of therapy. Efficacy will be measured by overall survival (OS), progression-free survival (PFS), and duration of response (DOR).