A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
Objective
Dose-Escalation Stage (XL092 Combination Therapy): The objectives of the Dose-Escalation Stage are to determine the recommended dose (RD) and evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics of XL092 in combination with the immuno-oncology agents nivolumab (doublet), nivolumab + ipilimumab (triplet), and nivolumab/relatlimab (triplet) in subjects with advanced cancers.
Expansion Stage (XL092 Monotherapy and Combination Therapy): The objectives of the Expansion Stage are to assess the preliminary efficacy of XL092 alone and in combination therapy regimens in tumor-specific cohorts, determine the safety of the combination therapy regimens, isolate the contribution of treatment components if applicable, and further evaluate the plasma PK of daily oral XL092 administered as a single agent or in combination therapy in subjects with advanced solid tumors.
