A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Trial sites expanded: 16 → 20 locations
  2. Trial sites expanded: 13 → 16 locations
    • Eligibility criteria expanded, about 22 words
    • Publications: details revised at 1 of 1 entry
  3. Study completion pushed from Sep 13, 2028 to Jan 2, 2029v32
  4. Study sites revised (13)v31
  5. Study sites revised (13)v30
Show 28 earlier versionsHide 28 earlier versions
  1. Site details revised at 1 of 13 sitesv29
  2. Site contacts updated at 1 of 13 sitesv28
  3. Study sites: 12 to 13v27
  4. Primary completion date: Mar 9, 2027 to Sep 13, 2028
    • Study completion date: May 8, 2027 to Sep 13, 2028
    v26
  5. Study completion date: Apr 30, 2027 to May 8, 2027v25
  6. Primary completion date: Jan 7, 2025 to Mar 9, 2027
    • Study sites: 13 to 12
    • Study completion date: Jan 31, 2027 to Apr 30, 2027
    v24
  7. Start date: Jan 19, 2023 to Feb 24, 2023
    • Study sites: 11 to 13
    v23
  8. Study completion date: Mar 10, 2027 to Jan 31, 2027v22
  9. Study sites: 10 to 11v21
  10. Study sites: 9 to 10v20
  11. Study sites: 7 to 9v19
  12. 2 versions Re-verified since May 2, 2023, no change to tracked fieldsv17-v18
  13. Study sites: 6 to 7v16
  14. Study sites: 4 to 6v15
  15. Study sites: 3 to 4v14
  16. Study sites: 2 to 3v13
  17. Study sites: 1 to 2v12
  18. Trial status: Not Yet Recruiting to Recruitingv11 Show 4 more changesShow less
    • Enrollment target: 36 to 66
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 16, 2023 to Jan 19, 2023
    • Eligibility criteria expanded, about 11 words
  19. Start date: Jan 9, 2023 to Jan 16, 2023v10
  20. Re-verified, no change to tracked fieldsv9
  21. Start date: Dec 12, 2022 to Jan 9, 2023v8
  22. Re-verified, no change to tracked fieldsv7
  23. Study completion date: Mar 24, 2027 to Mar 10, 2027
    • Start date: Nov 17, 2022 to Dec 12, 2022
    v6
  24. Re-verified, no change to tracked fieldsv5
  25. Eligibility criteria shortened, about 9 wordsv4
  26. Start date: Sep 21, 2022 to Nov 17, 2022
    • Primary completion date: Jul 15, 2024 to Jan 7, 2025
    • Study completion date: Dec 6, 2026 to Mar 24, 2027
    v3
  27. Re-verified, no change to tracked fieldsv2
  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.
This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time. Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks. Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT05471856
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)		 Solid Tumors
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov