Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors

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 CYP3

Trial Details

NCT ID
NCT05176483
Phase
PHASE1
Sponsor
Exelixis
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Zanzalintinib
  • Nivolumab
  • Ipilimumab
  • Nivolumab + Relatlimab
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Palo Alto, California, United States|37.44188,-122.14302
  • Santa Barbara, California, United States|34.42083,-119.69819
  • Littleton, Colorado, United States|39.61332,-105.01665

Key Eligibility Criteria

  • Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.
  • Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or…
  • Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior syste…
  • Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after…

For full eligibility, visit ClinicalTrials.gov.

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