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

Study acronym: STELLAR-002
StatusRecruiting
PhasePhase 1
SponsorExelixis
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 4 → 7 primary endpoints
See other at-risk trials from Exelixis

Record History

  1. Interventions modified Eligibility criteria expanded, about 73 words · Site details revised at 14 of 122 sites Show 2 more changesShow less
    • Eligibility criteria expanded, about 73 words
    • Site details revised at 14 of 122 sites
  2. Primary endpoint(s) modified Primary completion moved earlier from Jun 28, 2030 to Jan 31, 2027 · Trial arms changed: 7 → 9 · Enrollment target: 1314 to 1394 · 4 morev29 Show 7 more changesShow less
    • Primary completion moved earlier from Jun 28, 2030 to Jan 31, 2027
    • Trial arms changed: 7 → 9
    • Enrollment target: 1314 to 1394
    • Interventions: Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug), Zanzalintinib (Drug) to DDI Probe Cocktail (Drug), Docetaxel (Drug), Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab +…
    • Eligibility criteria expanded, about 190 words
    • Secondary endpoints: 2 to 7
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv28
  4. Site details revised at 1 of 122 sitesv27
  5. Site details revised at 2 of 122 sitesv26
Show 24 earlier versionsHide 24 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting Site details revised at 122 of 122 sitesv25 Show 1 more changeShow less
    • Site details revised at 122 of 122 sites
  2. Primary endpoints revised (4) Enrollment target: 1274 to 1314 · Eligibility criteria expanded, about 47 words · Secondary endpoints expanded, about 11 words · 1 morev24 Show 4 more changesShow less
    • Enrollment target: 1274 to 1314
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints expanded, about 11 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Feb 2026 to Jun 28, 2030 Trial status: Recruiting to Active, Not Recruiting · Completion date: May 2026 to Jun 28, 2030 · Site details revised at 122 of 122 sitesv23 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: May 2026 to Jun 28, 2030
    • Site details revised at 122 of 122 sites
  4. Enrollment target: 1078 to 1274 Interventions: Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug), XL092 (Drug) to Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug), Zanzalintinib (Drug) · Eligibility criteria expanded, about 118 wordsv22 Show 2 more changesShow less
    • Interventions: Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug), XL092 (Drug) to Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug), Zanzalintinib (Drug)
    • Eligibility criteria expanded, about 118 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 121 to 122v21
  6. Study sites: 114 to 121v20
  7. Study sites: 105 to 114v19
  8. Study sites: 72 to 105v18
  9. Study sites: 65 to 72v17
  10. Study sites: 62 to 65v16
  11. Study sites: 60 to 62v15
  12. Study sites: 51 to 60v14
  13. Study sites: 46 to 51v13
  14. Study sites: 43 to 46v12
  15. Study sites: 32 to 43v11
  16. Study sites: 29 to 32v10
  17. Study sites: 27 to 29v9
  18. Study sites: 19 to 27v8
  19. Study sites: 12 to 19v7
  20. Enrollment target: 622 to 1078 Primary endpoints: 3 to 4 · Study sites: 8 to 12 · Interventions: Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), XL092 (Drug) to Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug), XL092 (Drug) · 2 morev6 Show 5 more changesShow less
    • Primary endpoints: 3 to 4
    • Study sites: 8 to 12
    • Interventions: Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), XL092 (Drug) to Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab + Relatlimab (Drug), XL092 (Drug)
    • Eligibility criteria expanded, about 359 words
    • Study arms: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 7 to 8 Eligibility criteria expanded, about 2 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  22. Enrollment target: 826 to 622 Study sites: 4 to 7 · Interventions: Bempegaldesleukin (Drug), Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), XL092 (Drug) to Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), XL092 (Drug) · Eligibility criteria expanded, about 145 words · 1 morev4 Show 4 more changesShow less
    • Study sites: 4 to 7
    • Interventions: Bempegaldesleukin (Drug), Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), XL092 (Drug) to Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), XL092 (Drug)
    • Eligibility criteria expanded, about 145 words
    • Study arms: 9 to 6

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 1 to 4v3
  24. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Exelixis
25 trials monitored
See 2 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 5 more diseases
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.
Trial Details
NCT Number NCT05176483
Lead Sponsor Exelixis
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) +3 more
Enrollment 1,394 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov