Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
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
Exelixis
1,314 participants
Dec 14, 2021
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
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Interventions
Zanzalintinib orally once daily (qd)
360 mg IV infusion once every 3 weeks (q3w)
1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses
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)
480 mg IV infusion once every 4 weeks (q4w)
IV administration of nivolumab + relatlimab
Locations(122)
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NCT05176483