Study of Zanzalintinib in Combination With Immuno-Oncology 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) 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.

Trial Details

NCT ID
NCT05176483
Phase
PHASE1
Sponsor
Exelixis
Status
RECRUITING
Cancer Type
Lung 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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