Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors
A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology or Other Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
Exelixis
1,394 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) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates 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
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Zanzalintinib orally once daily (qd)
360 mg intravenous (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
Administered as IV infusion.
Administered as oral tablet.
Midazolam, Warfarin, Omeprazole, and Caffeine administered orally.
Locations(122)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05176483