Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
See other at-risk trials from Bicycle Therapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 31, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 46 words
    • Site details revised at 3 of 28 sites
  2. Primary completion date: Oct 1, 2025 to Jul 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 32 to 28
    • Study completion date: Oct 1, 2025 to Jul 31, 2027
    v29
  3. Study completion date: Oct 1, 2026 to Oct 1, 2025
    • Eligibility criteria expanded, about 35 words
    • Study sites revised (32)
    v28
  4. Primary completion date: Dec 31, 2023 to Oct 1, 2025
    • Study completion date: Dec 31, 2024 to Oct 1, 2026
    • Site details revised at 2 of 32 sites
    v27
  5. Site contacts updated at 1 of 32 sitesv26
Show 24 earlier versionsHide 24 earlier versions
  1. Site details revised at 1 of 32 sitesv25
  2. Enrollment target: 312 to 288
    • Eligibility criteria shortened, about 12 words
    • Site details revised at 1 of 32 sites
    • Study description shortened, about 1 word
    v24
  3. Study sites: 31 to 32v23
  4. Study sites: 30 to 31v22
  5. Study sites: 28 to 30v21
  6. Study sites: 27 to 28v20
  7. Study sites: 22 to 27v19
  8. Enrollment target: 166 to 312v18 Show 7 more changesShow less
    • Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Primary endpoints revised (9)
    • Study sites: 18 to 22
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Eligibility criteria expanded, about 666 words
    • Secondary endpoints: 11 to 17
    • Study arms: 5 to 3
  9. Study sites: 16 to 18v17
  10. Study sites: 14 to 16v16
  11. Study sites: 13 to 14v15
  12. Site details revised at 1 of 13 sitesv14
  13. Study sites: 12 to 13v13
  14. Study sites: 11 to 12v12
  15. Study sites: 10 to 11v11
  16. Study sites: 9 to 10v10
  17. Study sites: 8 to 9v9
  18. Study sites: 6 to 8v8
  19. Study sites: 5 to 6v7
  20. Eligibility criteria expanded, about 34 wordsv6
  21. Primary endpoints revised (9)
    • Study sites: 4 to 5
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (11)
    v5
  22. Primary endpoints revised (9)v4 Show 5 more changesShow less
    • Enrollment target: 152 to 166
    • Secondary endpoints: 13 to 11
    • Site contacts updated at 1 of 4 sites
    • Study arms: 4 to 5
    • Eligibility criteria shortened, about 4 words
  23. Site details revised at 1 of 4 sitesv3
  24. Study sites revised (4)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 1 trial at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,085 trials monitored
See 178 trials at risk
and 5 more diseases
This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab * Learn more about the side effects of BT5528 * Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. * Learn more about BT5528 therapy alone and in combination with nivolumab.
Trial Details
NCT Number NCT04180371
Lead Sponsor BicycleTx Limited
Conditions
(from sponsor)		 Advanced Solid Tumor Historically Known for High EphA2 Expression, Urothelial Cancer, Ovarian Cancer, Non-small Cell Lung Cancer, Head and Neck Cancer, Triple Negative Breast Cancer, Gastric/Upper Gastrointestinal Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms, Triple Negative Breast Neoplasms, Urinary Bladder Neoplasms
Enrollment 288 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov