Phase 1 Study of Zanzalintinib Alone and With Immunotherapy or Other Drugs in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are studying the safety, tolerability, and early effects of zanzalintinib alone and combined with other cancer drugs in people with advanced solid tumors. This Phase 1b study also looks at how zanzalintinib affects the bodys processing of certain medications in participants with advanced solid tumors. In the later Expansion Stage, the study further assesses the safety and effectiveness of zanzalintinib treatments in specific tumor groups. Participants receive zanzalintinib orally once daily, sometimes combined with intravenous infusions of nivolumab, ipilimumab, relatlimab, docetaxel, or prednisone. The study includes dose-escalation phases where doses are carefully increased and expansion cohorts focusing on particular tumor types or combinations. Some participants may also take a cocktail of drugs to study interactions with zanzalintinib. During the study, participants undergo regular assessments including monitoring for side effects, tumor response evaluations, and blood tests to measure drug levels and effects on the body. Researchers track adverse events, tumor shrinkage, survival outcomes, and progression-free survival over periods ranging up to 36 months. The study includes detailed safety monitoring and collects tumor tissue samples when possible to better understand treatment effects.

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