Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors
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.
Timeline
- Start
- 2021-12-14
- Primary completion
- 2027-01-31
- Completion
- 2030-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Docetaxel | Small molecule | — | Oral |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Omeprazole | Other / unclassified | — | Oral |
| Subject | Prednisone | Other / unclassified | — | Intravenous |
| Subject | Relatlimab | Monoclonal antibody | — | Intravenous |
| Subject | Warfarin | Small molecule | — | Oral |
| Subject | Zanzalintinib | Small molecule | — | Oral |