NCT05176483

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

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,314 (estimated)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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)

Interventions

Type	Name	Description
DRUG	Zanzalintinib	Zanzalintinib orally once daily (qd)
DRUG	Nivolumab	360 mg IV infusion once every 3 weeks (q3w)
DRUG	Ipilimumab	1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses
DRUG	Nivolumab	3 mg/kg IV infusion once every 3 weeks (q3w) for first four doses, and then 480 mg IV infusion once every 4 weeks (q4w)
DRUG	Nivolumab	480 mg IV infusion once every 4 weeks (q4w)
DRUG	Nivolumab + Relatlimab	IV administration of nivolumab + relatlimab

Timeline

• Start date: 2021-12-14
• Primary completion: 2030-06-28
• Completion: 2030-06-28
• First posted: 2022-01-04
• Last updated: 2026-03-12

Locations

122 sites across 13 countries: United States, Australia, Austria, Belgium, France, Germany, Israel, Italy, New Zealand, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study