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A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
SponsorExelixis
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Enrollment increased: 75 → 303 participants · Trial arms changed: 1 → 2 · Interventions: XB628 (Biological) to XB628 (Biological), Zanzalintinib (Drug) · 4 morev9 Show 7 more changesShow less
    • Enrollment increased: 75 → 303 participants
    • Trial arms changed: 1 → 2
    • Interventions: XB628 (Biological) to XB628 (Biological), Zanzalintinib (Drug)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (10)
    • Study description shortened, about 31 words
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion pushed from May 2027 to May 31, 2027 Study sites: 10 to 11 · Completion date: Nov 2027 to Nov 30, 2027v8 Show 2 more changesShow less
    • Study sites: 10 to 11
    • Completion date: Nov 2027 to Nov 30, 2027
  3. Study sites: 7 to 10v7
  4. Study sites: 4 to 7v6
  5. Study sites: 3 to 4v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 2 to 3v4
  2. Start date changed from estimate of May 2025 to May 1, 2025v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.
Trial Details
NCT Number NCT06952010
Lead Sponsor Exelixis
Conditions Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Immune Sensitive Tumor
Enrollment 303 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov