Stellar 002

Actively Recruiting

Phase 1b Dose-Escalation and Expansion Study of Zanzalintinib (XL092) in Combination With Immuno-oncology Agents in Advanced or Metastatic Solid Tumors

Uses and/or compounds described here are investigational. Safety and Efficacy have not been established.

  • Study Overview

  • Key Eligibility Criteria

  • Key Endpoints

  • Participating Sites

Study Overview

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

Key Endpoints

Dose-Escalation Stage

Primary Endpoint

  • Determine the safety and RD of the
    combination therapies

Exploratory Endpoints

  • ORR and DOR by investigator

  • PFS by investigator

  • PK

Cohort Expansion Stage

Primary Endpoints

  • ORR by investigator

  • Safety

  • mCRPC cohort: duration of
    radiographic PFS by BIRC

  • CRC cohort: OS at 6 months

Secondary Endpoints

  • DOR by investigator

  • PFS by investigator

Additional Endpoints

  • ORR, DOR, and PFS by BIRC

  • OS

  • mCRPC cohort:

    • Response based on >50% decrease in PSA from baseline

    • Change in bone biomarkers

1L, first-line; 2L, second-line; 2L+, second- and later-line; ALK, anaplastic lymphoma kinase; BIRC, blinded independent radiology committee; ccRCC, clear cell renal cell carcinoma; CPS, combined positive score; CRC, colorectal cancer; CRPC, castration-resistant prostate cancer; CTLA-4, cytotoxic T-lymphocyte–associated protein 4; dMMR, deficient mismatch repair; DOR, duration of response; EGFR, epidermal growth factor receptor; FDC, fixed-dose combination; HCC, hepatocellular carcinoma; HIF-2, hypoxia-inducible factor-2; HNSCC, head and neck squamous cell carcinoma; ICI, immune checkpoint inhibitor; IV, intravenous; LAG-3, lymphocyte activation gene-3; M0 CRPC, non-metastatic castration-resistant prostate cancer; mAb, monoclonal antibody; mCRC, metastatic colorectal cancer; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; MSI-high, microsatellite instability–high; MSS, microsatellite stable; MTD, maximum tolerated dose; nccRCC, non–clear cell renal cell carcinoma; NHT, novel hormonal therapy; NSCLC, non–small cell lung cancer; ORR, objective response rate; OS, overall survival; PD-1, programmed death receptor-1; PD-L1, programmed death receptor-1 ligand; PFS, progression-free survival; PK, pharmacokinetics; PSA, prostate-specific antigen; q3w, once every 3 weeks; q4w, once every 4 weeks; qd, once daily; RCC, renal cell carcinoma; RD, recommended dose; SOC, standard of care; TKI, tyrosine kinase inhibitor; TPS, tumor proportion score; UC, urothelial carcinoma; VEGF, vascular endothelial growth factor; VEGFR, vascular endothelial growth factor receptor.

Participating Sites

STELLAR-002 will be conducted in North America, Europe, Middle East, and Asia Pacific. Call 1-888-393-5494 (toll-free) or 1-303-389-1847 for specific location and site information and to confirm whether sites near you are still enrolling new patients.

Currently open or planned clinical site cities:

Trial sites may stop enrolling patients at any time. Please check back if you do not see a trial site located near you.

To learn more about this trial, go to and search for NCT05176483, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free),
1-303-389-1847, or