Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 9 months later Mar 2026 → Jan 2027
See other at-risk trials from Bicycle Therapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 2026 to Jan 2027 Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 8 entries
    • Study completion date: Dec 2026 to Jan 2027
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 2 of 21 entries
    • Site details revised at 1 of 24 sites
    • Publications: details revised at 2 of 2 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 29 to 24
    v29
  3. Primary completion date: Dec 2026 to Mar 2026
    • Secondary endpoints: details revised at 1 of 21 entries
    • Site details revised at 1 of 29 sites
    v28
  4. Primary and study completion dates: Dec 2025 to Dec 2026v27 Show 5 more changesShow less
    • Primary endpoints: 7 to 8
    • Eligibility criteria expanded, about 114 words
    • Secondary endpoints revised (21)
    • Study description expanded, about 20 words
    • Study arms: 11 to 13
  5. Study sites: 28 to 29v26
Show 24 earlier versionsHide 24 earlier versions
  1. Primary endpoints: 3 to 7v25 Show 4 more changesShow less
    • Study sites: 27 to 28
    • Secondary endpoints: 20 to 21
    • Study description expanded, about 11 words
    • Study arms: 10 to 11
  2. Study sites: 26 to 27v24
  3. Primary endpoints: 5 to 3v23 Show 5 more changesShow less
    • Study sites: 21 to 26
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 16 to 20
    • Study description shortened, about 12 words
    • Study title shortened, about 2 words
  4. Study title revisedv22
  5. Enrollment target: 172 to 329v21 Show 8 more changesShow less
    • Primary and study completion dates: Jun 2023 to Dec 2025
    • Primary endpoints: 9 to 5
    • Interventions: BT8009 (Drug), Nivolumab (Drug) to BT8009 (Drug), Pembrolizumab (Drug)
    • Eligibility criteria expanded, about 223 words
    • Secondary endpoints: 10 to 16
    • Study description expanded, about 14 words
    • Site contacts updated at 2 of 21 sites
    • Study arms: 5 to 10
  6. Study sites: 20 to 21v20
  7. Study sites: 18 to 20v19
  8. Site details revised at 1 of 18 sitesv18
  9. Study sites: 16 to 18v17
  10. Enrollment target: 146 to 172
    • Eligibility criteria expanded, about 46 words
    v16
  11. Study sites: 15 to 16v15
  12. Site details revised at 1 of 15 sitesv14
  13. Study sites: 14 to 15v13
  14. Study sites: 13 to 14v12
  15. Study sites: 11 to 13v11
  16. Study sites: 10 to 11v10
  17. Site details revised at 1 of 10 sitesv9
  18. Study sites: 8 to 10v8
  19. Study sites: 7 to 8v7
  20. Study sites: 5 to 7v6
  21. Study sites: 3 to 5
    • Eligibility criteria shortened, about 4 words
    v5
  22. Site contacts updated at 1 of 3 sitesv4
  23. Study sites: 2 to 3v3
  24. Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (10)
    v2
  1. Study First Submitted
  • 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.
Bicycle Therapeutics
8 trials monitored
See 2 trials at risk
Breast Cancer
5,466 trials monitored
See 312 trials at risk
Lung Cancer
4,803 trials monitored
See 272 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,087 trials monitored
See 179 trials at risk
and 3 more diseases
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).
Trial Details
NCT Number NCT04561362
Lead Sponsor BicycleTx Limited
Conditions
(from sponsor)		 Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms, Breast Neoplasms, Non-Small-Cell Lung Neoplasms, Ovarian Neoplasm, Advanced Solid Tumor
Related terms Breast Neoplasms, Ovarian Neoplasms, Renal Insufficiency, Triple Negative Breast Neoplasms, Urinary Bladder Neoplasms
Enrollment 329 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov