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First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

StatusRecruiting
PhasePhase 1/2
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 57 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Completion pushed from Jun 29, 2029 to Jun 30, 2031 Study sites: 94 to 92v57 Show 1 more changeShow less
    • Study sites: 94 to 92
  2. Minor Primary completion moved earlier from Nov 30, 2026 to Mar 16, 2026 Study sites revised (94)v56 Show 1 more changeShow less
  3. Notable Trial status changed: Active, Not Recruiting → Recruiting Trial sites expanded: 81 → 94 locations · Completion pushed from Dec 31, 2026 to Jun 29, 2029 · Enrollment target: 370 to 400 · 2 morev55 Show 5 more changesShow less
    • Trial sites expanded: 81 → 94 locations
    • Completion pushed from Dec 31, 2026 to Jun 29, 2029
    • Enrollment target: 370 to 400
    • Interventions: BAY2927088_formulation A (Drug), BAY2927088_formulation B_1 (Drug), BAY2927088_formulation B_2 (Drug) to BAY2927088_formulation A (Drug), BAY2927088_formulation B_1 (Drug), BAY2927088_formulation B_2 (Drug), BAY2927088_formulation B_3 (Drug)
    • Eligibility criteria shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Re-verified, no change to tracked fieldsv54
  5. Minor Site details revised at 3 of 81 sitesv53
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Study sites revised (81)v52 See this version in full on ClinicalTrials.gov ↗
  2. Minor Study sites revised (81)v51 See this version in full on ClinicalTrials.gov ↗
  3. Minor Study sites revised (81)v50 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study sites revised (81)v49 See this version in full on ClinicalTrials.gov ↗
  5. Notable Primary completion date: Dec 31, 2025 to Nov 30, 2026 Study sites revised (81)v48 Show 1 more changeShow less
  6. Minor Re-verified, no change to tracked fieldsv47
  7. Minor Study sites: 82 to 81v46
  8. Minor Study sites revised (82)v45 See this version in full on ClinicalTrials.gov ↗
  9. Minor Study sites revised (82)v44 See this version in full on ClinicalTrials.gov ↗
  10. Minor Study sites revised (82)v43 See this version in full on ClinicalTrials.gov ↗
  11. Minor Study sites revised (82)v42 See this version in full on ClinicalTrials.gov ↗
  12. Minor Re-verified, no change to tracked fieldsv41
  13. Minor Study sites revised (82)v40 See this version in full on ClinicalTrials.gov ↗
  14. Minor Study sites: 90 to 82v39
  15. Minor Trial status: Recruiting to Active, Not Recruiting Study sites: 94 to 90v38 Show 1 more changeShow less
    • Study sites: 94 to 90
  16. Minor Site details revised at 22 of 94 sitesv37
  17. Minor Study sites revised (94)v36 See this version in full on ClinicalTrials.gov ↗
  18. Minor Site details revised at 6 of 94 sitesv35
  19. Minor Study sites: 95 to 94v34
  20. Notable Primary completion date: Nov 30, 2027 to Dec 31, 2025 Completion date: Nov 30, 2027 to Dec 31, 2026 · Study sites revised (95)v33 Show 2 more changesShow less
    • Completion date: Nov 30, 2027 to Dec 31, 2026
    • Study sites revised (95)

    See this version in full on ClinicalTrials.gov ↗

  21. Minor Study sites revised (95)v32 See this version in full on ClinicalTrials.gov ↗
  22. Minor Enrollment target: 460 to 370 Eligibility criteria expanded, about 71 words · Secondary endpoints: details revised at 6 of 8 entries · Site details revised at 1 of 95 sitesv31 Show 3 more changesShow less
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints: details revised at 6 of 8 entries
    • Site details revised at 1 of 95 sites

    See this version in full on ClinicalTrials.gov ↗

  23. Minor Study sites revised (95)v30 See this version in full on ClinicalTrials.gov ↗
  24. Minor Eligibility criteria expanded, about 27 wordsv29 See this version in full on ClinicalTrials.gov ↗
  25. Minor Study sites: 88 to 95v28
  26. Minor Study sites: 80 to 88 Primary and study completion dates: Jul 31, 2028 to Nov 30, 2027v27 Show 1 more changeShow less
    • Primary and study completion dates: Jul 31, 2028 to Nov 30, 2027
  27. Notable Phase: Phase 1 to Phase 1/2 Primary endpoints: 13 to 14 · Enrollment target: 340 to 460 · Eligibility criteria revised · 3 morev26 Show 6 more changesShow less
    • Primary endpoints: 13 to 14
    • Enrollment target: 340 to 460
    • Eligibility criteria revised
    • Secondary endpoints: 2 to 8
    • Site details revised at 1 of 80 sites
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  28. Minor Site details revised at 2 of 80 sitesv25
  29. Minor Re-verified, no change to tracked fieldsv24
  30. Minor Study sites: 79 to 80v23
  31. Minor Study sites revised (79)v22 See this version in full on ClinicalTrials.gov ↗
  32. Notable Primary and study completion dates: Dec 31, 2025 to Jul 31, 2028 Study sites revised (79)v21 Show 1 more changeShow less
  33. Minor Site details revised at 9 of 79 sitesv20
  34. Minor Site details revised at 13 of 79 sitesv19
  35. Minor Study sites revised (79)v18 See this version in full on ClinicalTrials.gov ↗
  36. Minor Study sites: 78 to 79v17
  37. Minor Enrollment target: 250 to 340 Study sites: 76 to 78 · Eligibility criteria expanded, about 33 wordsv16 Show 2 more changesShow less
    • Study sites: 76 to 78
    • Eligibility criteria expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  38. Minor Study sites: 59 to 76v15
  39. Minor Study sites: 37 to 59v14
  40. Minor Study sites: 34 to 37v13
  41. Minor Study sites: 30 to 34v12
  42. Minor Site details revised at 9 of 30 sitesv11
  43. Notable Primary endpoints revised (13) Study sites: 27 to 30 · Eligibility criteria expanded, about 61 wordsv10 Show 2 more changesShow less
    • Study sites: 27 to 30
    • Eligibility criteria expanded, about 61 words

    See this version in full on ClinicalTrials.gov ↗

  44. Minor Study sites: 25 to 27v9
  45. Minor Study sites revised (25)v8 See this version in full on ClinicalTrials.gov ↗
  • 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.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC. The main purpose of this study is to learn: Escalation, Backfill, and Expansion Part: * How safe is BAY2927088 for the participants? * What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants? * How does BAY2927088 move into, through, and out of the bodies of the participants? For this, the researchers will measure the followings: * The number of participants with medical problems, also called adverse events and serious adverse events, and their severity * The number of participants who discontinue study treatment due to an adverse event. * The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088 * Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level * The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088 * The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part * How well does BAY2927088 work in participants? For this, the researchers will measure the following: • Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor. This study has 4 parts: * The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive. * The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part. * The expansion part aims to determine the dose of BAY2927088 to be tested in further studies. * The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well. The participants in this study will take the study treatment BAY2927088 in 3-week periods called "cycles". They will in general take BAY2927088 once or twice daily as a liquid/tablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle. During the study, the study team will: * take blood and urine samples, * check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans, * check the participants' overall health and heart health, * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is considered "serious" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.
Trial Details
NCT Number NCT05099172
Lead Sponsor Bayer
Conditions Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov