Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06760819 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Study acronym: panSOHO
StatusRecruiting
PhasePhase 2
SponsorBayer
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Feb 3, 2027 → Feb 2, 2029
See other at-risk trials from Bayer

Record History

  1. Eligibility criteria expanded, about 9 words Secondary endpoints: details revised at 9 of 16 entries · Site details revised at 14 of 54 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 9 of 16 entries
    • Site details revised at 14 of 54 sites
  2. Primary completion pushed from Feb 3, 2027 to Feb 2, 2029 Completion pushed from Oct 25, 2027 to Oct 26, 2029 · Study sites revised (54)v22 Show 2 more changesShow less
    • Completion pushed from Oct 25, 2027 to Oct 26, 2029
    • Study sites revised (54)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites revised (54)v21 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (54)v20 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (54)v19 See this version in full on ClinicalTrials.gov ↗
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites revised (54)v18 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (54)v17 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (54)v16 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (54)v15 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (54)v14 See this version in full on ClinicalTrials.gov ↗
  6. Re-verified, no change to tracked fieldsv13
  7. Study sites revised (54)v12 See this version in full on ClinicalTrials.gov ↗
  8. Study sites revised (54) Eligibility criteria expanded, about 2 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites revised (54)v10 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 51 to 54 Study title expanded, about 2 wordsv9 Show 1 more changeShow less
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  11. Secondary endpoints: details revised at 1 of 16 entries Study sites revised (51)v8 Show 1 more changeShow less
    • Study sites revised (51)

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites revised (51)v7 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 50 to 51v6
  14. Study sites revised (50)v5 See this version in full on ClinicalTrials.gov ↗
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 49 to 50 · Start date changed from estimate of Mar 3, 2025 to Feb 13, 2025v4 Show 2 more changesShow less
    • Study sites: 49 to 50
    • Start date changed from estimate of Mar 3, 2025 to Feb 13, 2025
  16. Study sites: 47 to 49v3
  17. Site details revised at 1 of 47 sitesv2
  1. Study First Submitted
  • 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.
Bayer
131 trials monitored
See 7 trials at risk
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
Trial Details
NCT Number NCT06760819
Lead Sponsor Bayer
Conditions Advanced Solid Tumors, HER2 Mutation
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov