Spots Global Cancer Trial Database for Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

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Trial Identification

Brief Title: Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Study ID: NCT05433142

Conditions

Clear Cell Renal Cell Carcinoma

Interventions

XmAb819

Study Description

Brief Summary: The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

Detailed Description: This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part A, dose escalation, and Part B, dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC. All eligible subjects will have relapsed or refractory disease after standard therapy.