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
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet) and nivolumab + ipilimumab (triplet) in patients with advanced solid tumors. In the Expansion Stage, the safety and efficacy of XL092 as combination therapy will be further evaluated in tumor-specific Expansion Cohorts, which will enroll patients with genitourinary cancers.
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 + BEMPEG (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, determine the contribution of treatment components, and further evaluate the plasma PK of daily oral XL092 administered as a single agent or in combination therapy in subjects with advanced genitourinary cancers.
BMS-936558 (Nivolumab); Bempegaldesleukin (); Ipilimumab (); NKTR-214 (Bempegaldesleukin); Nivolumab (Opdivo); XL092 (); Yervoy (Ipilimumab)
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