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A Phase 1, Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®819 in Subjects with Relapsed or Refractory Clear Cell Renal Cell Carcinoma.

Primary:
- To assess the safety and tolerability of XmAb819 administered IV in subjects with relapsed or refractory ccRCC.

- To assess the safety and tolerability of XmAb819 administered SC in subjects with relapsed or refractory ccRCC.

- To identify the minimum safe and biologically effective dose, the RD for the cohort-limit dose, and the schedule for dose expansion of XmAb819 in subjects with relapsed or refractory ccRCC.

Secondary:
- To characterize the PK of XmAb819 when administered as monotherapy.

- To assess the immunogenicity of XmAb819 when administered as monotherapy.

- To assess preliminary antitumor activity of XmAb819 by ORR, PFS, DOR, and OS per RECIST 1.1 criteria.

Protocol Number: 082409
Phase: Phase I
Applicable Disease Sites: Kidney
Drugs Involved: XmAb819
Principal Investigator: Biren Saraiya
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.