NCT06191796

Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

A Phase 1b/2 Dose-finding and Expansion Study Evaluating the Safety and Efficacy of Zanzalintinib (XL092) Combined With Either AB521 or AB521 Plus Nivolumab in Subjects With Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. The main questions it aims to answer are: * The recommended doses (RDs) * The safety and tolerability * The PK and the preliminary efficacy

Conditions

• Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	zanzalintinib	Specified doses on specified days
DRUG	AB521	Specified doses on specified days
BIOLOGICAL	Nivolumab	Specified doses on specified days

Timeline

• Start date: 2024-01-25
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2024-01-05
• Last updated: 2025-06-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study