NCT05433142

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 307 (estimated)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: dose escalation, and 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 and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	XmAb819	Monoclonal Bispecific Antibody

Timeline

• Start date: 2022-06-13
• Primary completion: 2027-02-01
• Completion: 2028-12-01
• First posted: 2022-06-27
• Last updated: 2026-03-05

Locations

23 sites across 4 countries: United States, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study