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Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

StatusRecruiting
PhasePhase 1/2
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv23
  2. Primary completion date: Feb 28, 2026 to Jan 31, 2029 Completion date: Sep 30, 2027 to Jan 31, 2029v22 Show 1 more changeShow less
    • Completion date: Sep 30, 2027 to Jan 31, 2029
  3. Enrollment target: 127 to 146 Secondary endpoints: 24 to 25v21 Show 1 more changeShow less
    • Secondary endpoints: 24 to 25

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 30 to 29v20
  5. Primary completion date: Mar 2027 to Feb 28, 2026 Primary endpoints revised (5) · Completion date: Mar 2027 to Sep 30, 2027 · Eligibility criteria expanded, about 11 words · 1 morev19 Show 4 more changesShow less
    • Primary endpoints revised (5)
    • Completion date: Mar 2027 to Sep 30, 2027
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 23 to 24

    See this version in full on ClinicalTrials.gov ↗

Show 17 earlier versionsHide 17 earlier versions
  1. Site details revised at 1 of 30 sitesv18
  2. Study sites: 28 to 30v17
  3. Primary endpoints revised (5) Study sites: 30 to 28 · Secondary endpoints: 22 to 23v16 Show 2 more changesShow less
    • Study sites: 30 to 28
    • Secondary endpoints: 22 to 23

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (30)v15 See this version in full on ClinicalTrials.gov ↗
  5. Start date: Mar 24, 2022 to May 6, 2022 Study sites: 24 to 30v14 Show 1 more changeShow less
    • Study sites: 24 to 30
  6. Study sites: 23 to 24 Eligibility criteria shortened, about 4 wordsv13 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  7. Phase: Phase 1 to Phase 1/2 Primary endpoints: 3 to 5 · Enrollment target: 116 to 127 · Secondary endpoints: 16 to 22 · 1 morev12 Show 4 more changesShow less
    • Primary endpoints: 3 to 5
    • Enrollment target: 116 to 127
    • Secondary endpoints: 16 to 22
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv11
  9. Study sites: 21 to 23v10
  10. Study sites: 18 to 21v9
  11. Study sites: 14 to 18v8
  12. Study sites: 24 to 14v7
  13. Study sites: 8 to 24v6
  14. Enrollment target: 76 to 116 Primary endpoints: 2 to 3 · Study sites: 9 to 8 · Eligibility criteria expanded, about 29 words · 3 morev5 Show 6 more changesShow less
    • Primary endpoints: 2 to 3
    • Study sites: 9 to 8
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (16)
    • Study title revised
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  15. Site details revised at 3 of 9 sitesv4
  16. Study sites: 1 to 9v3
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 2022 to Mar 24, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2022 to Mar 24, 2022
  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
Leukemia
2,566 trials monitored
See 143 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
DLBCL
650 trials monitored
See 38 trials at risk
and 3 more diseases
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
Trial Details
NCT Number NCT05294731
Lead Sponsor BeiGene
Conditions B-cell Malignancy, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia, Marginal Zone Lymphoma, Follicular Lymphoma, DLBCL Unclassifiable +1 more
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov