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

Recruiting now · Phase 1

Conditions studied: Renal Cell Carcinoma (RCC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Urothelial Carcinoma (UC), Solid Tumor, Hepatocellular Carcinoma (HCC), Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Head and Neck Squamous Cell Carcinoma (HNSCC), Clear Cell Renal Cell Carcinoma (ccRCC), Non-Clear Cell Renal Cell Carcinoma (nccRCC), Drug-Drug Interaction (DDI)

In brief

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.

Key facts

Study ID
NCT05176483
Run by
Exelixis
People needed
1394
Starts
2021-12-14
Expected to finish
2030-06-28
Last updated by the study team
2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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