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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)
NCT05099172 · View on ClinicalTrials.gov ↗
Study Summary
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, 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
Conditions Studied
Interventions
- DRUG BAY2927088_formulation A
- DRUG BAY2927088_formulation B_1
- DRUG BAY2927088_formulation B_2
Study Locations (20)
Beijing Municipality
- Beijing Cancer Hospital - Oncology Department — Beijing
- Beijing Hospital — Beijing
Arizona
- Banner MD Anderson Cancer Center at Banner Gateway Medical Center — Gilbert
California
- City of Hope - Duarte Cancer Center — Duarte
Georgia
- Emory Winship Cancer Institute — Atlanta
Maryland
- The Center for Cancer and Blood Disorders — Bethesda
Massachusetts
- Dana-Farber Cancer Institute - Oncology Department — Boston
Michigan
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit — Detroit
New York
- NYU Langone Hospital - Long Island - Urology — Mineola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05099172
The ClinicalTrials.gov registry entry for NCT05099172 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Advanced Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which BAY2927088_formulation A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05099172 reports 20 study locations spanning 19 distinct geographic areas — top geographies include Beijing Municipality, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05099172 about?
NCT05099172 is a clinical study titled "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)". 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 pr...
What is the current status of trial NCT05099172?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 370 participants. The study started on 2021-10-25. Estimated completion is 2026-12-31.
What conditions does trial NCT05099172 study?
This clinical trial studies the following conditions: Advanced Non-small Cell Lung Cancer, HER2 Mutation, EGFR Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05099172?
The interventions under investigation include: BAY2927088_formulation A (DRUG), BAY2927088_formulation B_1 (DRUG), BAY2927088_formulation B_2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05099172?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05099172 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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