Phase 1 Study to Assess Safety and Dosing of XmAb819 in Adults With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating XmAb819, a monoclonal bispecific antibody, in adults with relapsed or refractory clear cell renal cell carcinoma ccRCC and other solid tumors who have progressed after standard therapy. This Phase 1, multicenter, open-label study aims to assess the safety and tolerability of XmAb819, determine the minimum safe and biologically active dose, and establish a recommended dose for further research. The study also explores pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity. The study has two parts dose escalation and dose expansion. During dose escalation, dosing schedules for intravenous IV and subcutaneous SC administration of XmAb819 are established, including priming and step-up priming doses. In the dose expansion phase, participants may receive XmAb819 by IV or SC routes. Treatments are given in multiple doses to assess safety and biological activity. Participants will be evaluated through assessments of adverse events, dose-limiting toxicities, and pharmacokinetic measures such as maximum concentration and area under the curve. Tumor response and progression-free survival will be monitored. Safety and tolerability will be followed for 28 days after dosing, with additional outcome measures assessed up to 56 days or 42 days depending on the endpoint. The study lasts until completion in December 2028.

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