Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: XL092 + Nivolumab Dose-Escalation Cohorts
  Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
• Experimental: XL092 + Nivolumab + Ipilimumab Dose-Escalation Cohorts
  Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
• Experimental: XL092 + Nivolumab Expansion Cohorts
  The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
• Experimental: XL092 + Nivolumab + Ipilimumab Expansion Cohorts
  The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
• Experimental: XL092 Single-Agent Expansion Cohorts
• Experimental: XL092 + Nivolumab + Relatlimab Dose-Escalation Cohorts
  Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
• Experimental: XL092 + Nivolumab + Relatlimab Expansion Cohorts
  The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

Geprüfte Regime

• XL092:
  XL092 orally once daily (qd)
• Nivolumab (Opdivo):
  360 mg IV infusion once every 3 weeks (q3w)
• Ipilimumab (Yervoy):
  1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses
• Nivolumab (Opdivo):
  3 mg/kg IV infusion once every 3 weeks (q3w) for first four doses, and then 480 mg IV infusion once every 4 weeks (q4w)
• Nivolumab (Opdivo):
  480 mg IV infusion once every 4 weeks (q4w)
• Nivolumab + Relatlimab:
  IV administration of nivolumab + relatlimab

Quelle: ClinicalTrials.gov