Stellar 001

Active, Not Recruiting

Phase 1 Dose-Escalation and Expansion Study of Zanzalintinib (XL092) Alone or in Combination in Locally Advanced or Metastatic Solid Tumors


  • Study Overview

  • Key Eligibility Criteria

  • Key Endpoints

  • Participating Sites

Study Overview

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of Zanzalintinib as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors.

Key Endpoints

Dose-Escalation Stage

Primary Endpoint

  • Determine MTD and/or RD

Secondary Endpoints

  • Safety

  • PK

Exploratory Endpoint

  • ORR by investigator

Cohort Expansion Stage

Primary Endpoints

  • ORR by investigator

  • PFS rate by investigator (except for CRC cohort)

  • OS (for RASWT, CRC cohort)

Secondary Endpoint

  • Safety

Exploratory Endpoints

  • DOR by investigator

  • PFS by investigator

  • ORR, DOR, and PFS by BIRC

  • OS

BIRC, blinded independent radiology committee; ccRCC, clear cell renal cell carcinoma; CRC, colorectal cancer; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; HER-2, human epidermal growth factor receptor 2; HR+ BC, hormone receptor–positive breast cancer; ICI, immune checkpoint inhibitor; IV, intravenous; 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, microsatellite instability; MSS, microsatellite stable; MTD, maximum tolerated dose; nccRCC, non–clear cell renal cell carcinoma; NHT, novel hormonal therapy; 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; q2w, once every 2 weeks; q3w, once every 3 weeks; qd, once daily; RD, recommended dose; SC, steering committee; SOC, standard of care; VEGF, vascular endothelial growth factor; VEGFR, vascular endothelial growth factor receptor; WT, wild-type.

Participating Sites

STELLAR-001 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 NCT03845166, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free),
1-303-389-1847, or