A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab

StatusActive, Not Recruiting
PhasePhase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion moved earlier from Jul 14, 2027 to Nov 25, 2026
    • Eligibility criteria expanded, about 16 words
  2. Primary completion moved earlier from Sep 16, 2026 to Jan 22, 2026
    • Study completion pushed from Sep 16, 2026 to Jul 14, 2027
    v44
  3. Primary completion pushed from May 29, 2026 to Sep 16, 2026
    • Study completion date: Aug 28, 2026 to Sep 16, 2026
    v43
  4. Study completion date: Aug 6, 2026 to Aug 28, 2026v42
  5. Primary completion pushed from Apr 3, 2026 to May 29, 2026
    • Study completion pushed from May 31, 2026 to Aug 6, 2026
    v41
Show 39 earlier versionsHide 39 earlier versions
  1. Re-verified, no change to tracked fieldsv40
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 13 to confirmed 14
    • Site details revised
    v39
  3. Primary completion date: Jan 16, 2026 to Apr 3, 2026
    • Study completion date: Mar 15, 2026 to May 31, 2026
    v38
  4. Primary completion date: Oct 16, 2025 to Jan 16, 2026
    • Study completion date: Dec 15, 2025 to Mar 15, 2026
    v37
  5. Study completion date: Dec 15, 2026 to Dec 15, 2025v36
  6. Primary completion date: Jun 13, 2025 to Oct 16, 2025v35
  7. Study completion date: Oct 18, 2025 to Dec 15, 2026v34
  8. Study completion date: Aug 15, 2025 to Oct 18, 2025v33
  9. Start date: Nov 16, 2021 to Mar 3, 2022v32
  10. Primary completion date: Mar 14, 2025 to Jun 13, 2025
    • Study completion date: May 16, 2025 to Aug 15, 2025
    v31
  11. Primary completion date: Jan 17, 2025 to Mar 14, 2025
    • Study completion date: Mar 21, 2025 to May 16, 2025
    v30
  12. Primary completion date: Jul 12, 2024 to Jan 17, 2025
    • Study completion date: Oct 31, 2024 to Mar 21, 2025
    • Study site revised
    v29
  13. Enrollment target: 12 to 13
    • Primary completion date: Apr 24, 2024 to Jul 12, 2024
    • Study completion date: Dec 23, 2024 to Oct 31, 2024
    v28
  14. Enrollment target: 22 to 12
    • Primary completion date: Nov 10, 2023 to Apr 24, 2024
    • Study completion date: Jul 22, 2024 to Dec 23, 2024
    v27
  15. 13 versions Re-verified since Aug 9, 2022, no change to tracked fieldsv14-v26
  16. Primary endpoints: 1 to 2v13 Show 4 more changesShow less
    • Interventions: BI 765063 (Drug), [89Zr]Zr- BI 765063 (Drug), ezabenlimab (Drug) to BI 765063 (Drug), BI 770371 (Drug), Ezabenlimab (Drug), [89Zr]Zr- BI 765063 (Drug), [89Zr]Zr- BI 770371 (Drug)
    • Eligibility criteria expanded, about 10 words
    • Study arms: 1 to 2
    • Study title expanded, about 3 words
  17. Re-verified, no change to tracked fieldsv12
  18. Primary completion date: Nov 17, 2022 to Nov 10, 2023
    • Study completion date: Mar 6, 2023 to Jul 22, 2024
    • Site contact updated
    v11
  19. 6 versions Re-verified since Jan 11, 2022, no change to tracked fieldsv5-v10
  20. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  21. Study completion date: Apr 17, 2023 to Mar 6, 2023
    • Start date: Nov 5, 2021 to Nov 16, 2021
    v3
  22. Start date: Sep 28, 2021 to Nov 5, 2021
    • Primary endpoint revised
    • Primary completion date: Nov 21, 2022 to Nov 17, 2022
    • Study completion date: Mar 6, 2023 to Apr 17, 2023
    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.
Boehringer Ingelheim
223 trials monitored
See 11 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
Head & Neck Cancer
2,608 trials monitored
See 150 trials at risk
and 1 more disease
This study is open to adults with advanced head and neck cancer, skin cancer, or non-small cell lung cancer. People can take part if previous treatments were not successful. The purpose of this study is to find out how 2 medicines called BI 765063 and BI 770371 are taken up in the tumours and how they get distributed in the body. In addition to BI 765063 or BI 770371, participants also receive ezabenlimab. BI 765063, BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors. Participants get either BI 765063 or BI 770371 in combination with ezabenlimab as an infusion into a vein every 3 weeks. In the first weeks, doctors check how BI 765063 and BI 770371 are taken up in tumours. To do so, the doctors use imaging methods (PET/CT scans). For this, participants get BI 765063 or BI 770371 injected in a labelled form up to 2 times. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT05068102
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)		 Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)
Related terms Carcinoma, Carcinoma, Non-Small-Cell Lung, Melanoma, Squamous Cell Carcinoma of Head and Neck
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov