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A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

StatusActive, Not Recruiting
PhasePhase 1
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 18, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv33
  2. Study sites: 23 to 24v32
  3. Enrollment reduced: 258 → 103 participants Primary completion moved earlier from Apr 2028 to Aug 31, 2026 · Trial status changed: Recruiting → Active, Not Recruiting · Completion moved earlier from Jul 2028 to Aug 31, 2026 · 1 morev31 Show 4 more changesShow less
    • Primary completion moved earlier from Apr 2028 to Aug 31, 2026
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Completion moved earlier from Jul 2028 to Aug 31, 2026
    • Study sites: 24 to 23
  4. Re-verified, no change to tracked fieldsv30
  5. Study sites revised (24)v29 See this version in full on ClinicalTrials.gov ↗
Show 27 earlier versionsHide 27 earlier versions
  1. Site details revised at 1 of 24 sitesv28
  2. Study sites: 30 to 24v27
  3. Enrollment target: 218 to 258 Study sites: 33 to 30 · Primary completion date: Feb 28, 2028 to Apr 2028 · Completion date: Feb 28, 2028 to Jul 2028v26 Show 3 more changesShow less
    • Study sites: 33 to 30
    • Primary completion date: Feb 28, 2028 to Apr 2028
    • Completion date: Feb 28, 2028 to Jul 2028
  4. 2 versions Re-verified since Sep 11, 2025, no change to tracked fieldsv24-v25
  5. Site details revised at 8 of 33 sitesv23
  6. Re-verified, no change to tracked fieldsv22
  7. Site details revised at 2 of 33 sitesv21
  8. Site details revised at 1 of 33 sitesv20
  9. Study sites revised (33)v19 See this version in full on ClinicalTrials.gov ↗
  10. Enrollment target: 138 to 218 Eligibility criteria expanded, about 49 words · Study arms: 4 to 5v18 Show 2 more changesShow less
    • Eligibility criteria expanded, about 49 words
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 32 to 33v17
  12. Study sites: 31 to 32v16
  13. Site details revised at 12 of 31 sitesv15
  14. Site details revised at 1 of 31 sitesv14
  15. Study sites: 30 to 31v13
  16. Site details revised at 1 of 30 sitesv12
  17. Study sites revised (30)v11 See this version in full on ClinicalTrials.gov ↗
  18. Site details revised at 5 of 30 sitesv10
  19. Study sites: 11 to 30v9
  20. Primary and study completion dates: Dec 31, 2026 to Feb 28, 2028 Primary endpoints revised (5) · Enrollment target: 108 to 138 · Study sites: 7 to 11 · 5 morev8 Show 8 more changesShow less
    • Primary endpoints revised (5)
    • Enrollment target: 108 to 138
    • Study sites: 7 to 11
    • Start date: Feb 28, 2024 to Mar 11, 2024
    • Interventions: BG-68501 (Drug), Fulvestrant (Drug) to BG-68501 (Drug), BGB-43395 (Drug), Fulvestrant (Drug)
    • Eligibility criteria expanded, about 145 words
    • Secondary endpoints revised (11)
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 11 to 7v7
  22. Study sites: 9 to 11v6
  23. Study sites: 8 to 9v5
  24. Study sites: 5 to 8v4
  25. Study sites: 2 to 5v3
  26. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Primary and study completion dates: Oct 12, 2026 to Dec 31, 2026 · Start date changed from estimate of Feb 19, 2024 to Feb 28, 2024v2 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Primary and study completion dates: Oct 12, 2026 to Dec 31, 2026
    • Start date changed from estimate of Feb 19, 2024 to Feb 28, 2024
  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
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
and 7 more diseases
This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-68501 in participants with advanced, nonresectable, or metastatic solid tumors as monotherapy and in combination with fulvestrant with or without BGB-43395, a selective CDK4 inhibitor, in adults with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC). The study will also identify a recommended dose for expansion (RDFE) for BG-68501 as monotherapy and in combination for subsequent disease directed studies. The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion, including evaluation of food effect) and Part 2 (dose expansion).
Trial Details
NCT Number NCT06257264
Lead Sponsor BeiGene
Conditions Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced Solid Tumor, Endometrial Cancer +4 more
Enrollment 103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov