drugset / Trial / NCT05176483
Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-12-14
- Primary completion
- 2030-06-28
- Completion
- 2030-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Relatlimab | Monoclonal antibody | — | Intravenous |
| Subject | Zanzalintinib | Small molecule | — | Oral |