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

Summary

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Zanzalintinib

  Zanzalintinib orally once daily (qd)

• Drug
  Nivolumab

  360 mg IV infusion once every 3 weeks (q3w)

• Drug
  Ipilimumab

  1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses

• Drug
  Nivolumab

  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)

• Drug
  Nivolumab

  480 mg IV infusion once every 4 weeks (q4w)

• Drug
  Nivolumab + Relatlimab

  IV administration of nivolumab + relatlimab

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