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BAY2927088_formulation B_3 / EGFR Mutation / Advanced Non Small Cell Lung Cancer · Phase 1/2 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an ongoing first-in-human trial of sevabertinib (BAY2927088), a dual EGFR/HER2 inhibitor, in advanced NSCLC patients with relevant mutations. The study is designed to establish safety, maximum tolerated dose, pharmacokinetics, and preliminary efficacy, but no results are yet posted in this registry record and the trial remains in recruitment.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation; age from 18 Years. Intervention: Dose escalation; Backfill; Dose expansion; Extension part. n = 400. 92 sites across 16 countries.
This is a registry record for an ongoing first-in-human trial of sevabertinib (BAY2927088), a dual EGFR/HER2 inhibitor, in advanced NSCLC patients with relevant mutations. The study is designed to establish safety, maximum tolerated dose, pharmacokinetics, and preliminary efficacy, but no results are yet posted in this registry record and the trial remains in recruitment.
No interim safety or efficacy data are available in this record
This trial is in early recruitment phase with no efficacy or safety results yet available. Clinicians should await completion and results reporting before considering any practice implications. The dual EGFR/HER2 targeting approach is of interest for resistant or complex mutation patterns.
This is a first-in-human Phase 1/2 trial registration with no results reported; the study is actively recruiting and designed to establish safety, tolerability, and preliminary efficacy of a novel dual EGFR/HER2 inhibitor in advanced NSCLC.
As stated by the source record.
Quoted from the source exactly as published.
This trial is in early recruitment phase with no efficacy or safety results yet available. Clinicians should await completion and results reporting before considering any practice implications. The dual EGFR/HER2 targeting approach is of interest for resistant or complex mutation patterns.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05099172). This is a study registration, not published results. Lead sponsor: Bayer. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation. Interventions: DRUG: BAY2927088_formulation A; DRUG: BAY2927088_formulation B_1; DRUG: BAY2927088_formulation B_2; DRUG: BAY2927088_formulation B_3. Primary outcome measures: Number of participants with treatment-emergent adverse events (TEAEs) , Up to 30 days after the last administration of study treatment; Number of participants with treatment-emergent serious adverse events (TESAEs) , Up to 30 days after the last administration of study treatment; Severity of TEAEs , Up to 30 days after the last administration of study treatment; Severity of TESAEs , Up to 30 days after the last administration of study treatment; Number of participants who discontinue study treatment due to an AE , About 4 years (Up to the end of study treatment); Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population) , At the end of Cycle 1 of a 21-day cycle; Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill) , At the end of Cycle 1 of a 21-day cycle; Cmax of BAY2927088 , Cycle 1, Day 1 (Cycle duration is 21 days); AUC(0-24) of BAY2927088 for QD , Cycle 1, Day 1 (Cycle duration is 21 days); AUC(0-12) of BAY2927088 for BID , Cycle 1, Day 1 (Cycle duration is 21 days); Cmax,md of BAY2927088 , Cycle 1, Day 15 (Cycle duration is 21 days); AUC(0-24)md of BAY2927088 for QD , Cycle 1, Day 15 (Cycle duration is 21 days); AUC(0-12)md of BAY2927088 for BID , Cycle 1, Day 15 (Cycle duration is 21 days); Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension part , From the start of the study treatment up to 12 months. Brief 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, 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
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