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A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv33
  2. Results first posted: Jun 30, 2026 Site details revised at 1 of 64 sitesv32 Show 1 more changeShow less
    • Site details revised at 1 of 64 sites
  3. Primary endpoints revised (2) Study sites: 76 to 64 · Interventions: 5-Fluorouracil (Drug), Bevacizumab or Bevacizumab biosimilar (Drug), Capecitabine (Drug), LBL-007 (Drug), Tislelizumab (Drug) to Alcestobart (Drug), Bevacizumab or Bevacizumab biosimilar (Drug), Fluoropyrimidine (FP) (Drug), Tislelizumab (Drug) · Secondary endpoints: 4 to 6 · 3 morev31 Show 6 more changesShow less
    • Study sites: 76 to 64
    • Interventions: 5-Fluorouracil (Drug), Bevacizumab or Bevacizumab biosimilar (Drug), Capecitabine (Drug), LBL-007 (Drug), Tislelizumab (Drug) to Alcestobart (Drug), Bevacizumab or Bevacizumab biosimilar (Drug), Fluoropyrimidine (FP) (Drug), Tislelizumab (Drug)
    • Secondary endpoints: 4 to 6
    • Study arms: 7 to 8
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Jun 9, 2025, no change to tracked fieldsv29-v30
  5. Primary completion date: Apr 15, 2026 to May 23, 2025 Completion date: Apr 15, 2026 to Dec 31, 2026 · Secondary endpoints: 20 to 4v28 Show 2 more changesShow less
    • Completion date: Apr 15, 2026 to Dec 31, 2026
    • Secondary endpoints: 20 to 4

    See this version in full on ClinicalTrials.gov ↗

Show 26 earlier versionsHide 26 earlier versions
  1. Primary and study completion dates: Apr 2028 to Apr 15, 2026 Primary endpoints revised (2) · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 226 to confirmed 113 · 4 morev27 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 226 to confirmed 113
    • Study sites: 39 to 76
    • Interventions: 5-Fluorouracil (Drug), Bevacizumab biosimilar (Drug), Bevacizumab biosimilar (Drug), Capecitabine (Drug), LBL-007 (Drug), LBL-007 (Drug)… to 5-Fluorouracil (Drug), Bevacizumab or Bevacizumab biosimilar (Drug), Capecitabine (Drug), LBL-007 (Drug), Tislelizumab (Drug)
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints revised (20)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 75 to 39v26
  3. Study sites revised (75)v25 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 73 to 75v24
  5. Study sites: 68 to 73v23
  6. Study sites: 61 to 68v22
  7. Study sites: 56 to 61v21
  8. Study sites: 48 to 56v20
  9. Study sites: 47 to 48v19
  10. Study sites: 46 to 47v18
  11. Study sites: 45 to 46v17
  12. Study sites: 41 to 45v16
  13. Study sites: 39 to 41v15
  14. Study sites: 37 to 39v14
  15. Study sites: 33 to 37v13
  16. Study sites: 34 to 33v12
  17. Study sites: 33 to 34v11
  18. Study sites: 15 to 33v10
  19. Primary completion date: Feb 2025 to Apr 2028 Enrollment target: 202 to 226 · Study sites: 14 to 15 · Completion date: Aug 2026 to Apr 2028 · 5 morev9 Show 8 more changesShow less
    • Enrollment target: 202 to 226
    • Study sites: 14 to 15
    • Completion date: Aug 2026 to Apr 2028
    • Interventions: Bevacizumab (Drug), Capecitabine (Drug), LBL-007 (Drug), LBL-007 (Drug), Tislelizumab (Drug) to 5-Fluorouracil (Drug), Bevacizumab biosimilar (Drug), Bevacizumab biosimilar (Drug), Capecitabine (Drug), LBL-007 (Drug), LBL-007 (Drug)…
    • Eligibility criteria shortened, about 44 words
    • Secondary endpoints: details revised at 11 of 20 entries
    • Study title revised
    • Study arms: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  20. Trial status: Active, Not Recruiting to Recruiting Study sites: 93 to 14v8 Show 1 more changeShow less
    • Study sites: 93 to 14
  21. Trial status: Recruiting to Active, Not Recruiting Study sites: 14 to 93v7 Show 1 more changeShow less
    • Study sites: 14 to 93
  22. Study sites: 11 to 14v6
  23. Study sites: 8 to 11v5
  24. Study sites: 5 to 8 Start date changed from estimate of Feb 2023 to Jan 29, 2023v4 Show 1 more changeShow less
    • Start date changed from estimate of Feb 2023 to Jan 29, 2023
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5v3 Show 1 more changeShow less
    • Study sites: 0 to 5
  26. Start date: Nov 2022 to Feb 2023v2
  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.
BeiGene
37 trials monitored
See 1 trial at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
This is a Phase 1b/2 study to investigate the efficacy and safety of alcestobart (LBL-007) plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and alcestobart in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine to participants with colorectal cancer.
Trial Details
NCT Number NCT05609370
Lead Sponsor BeiGene
Conditions Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Enrollment 113 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov