Clinical Trials

Multiple clinical trials sponsored by Bayer are evaluating sevabertinib (BAY 2927088) across Phase 1, Phase 2, and Phase 3 stages, focusing on advanced non-small cell lung cancer with EGFR or HER2 mutations, advanced solid tumors, and pharmacokinetic profiling in healthy volunteers and individuals with hepatic impairment. Actively recruiting investigations include Phase 1/2 and Phase 2 efficacy trials in mutant lung carcinoma and HER2-mutant solid tumors. Furthermore, several Phase 1 pharmacokinetic and drug-interaction studies have been completed, and an expanded access program is currently available.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06760819 RECRUITING
Advanced Solid Tumors; HER2 Mutation
Bayer
 2025-02-13 PHASE2
NCT06452277 RECRUITING
Advanced Non-small Cell Lung Cancer, HER2 Mutation
Bayer
 2024-08-28 PHASE3
NCT07753252 NOT_YET_RECRUITING
Healthy Participants
Bayer
 2026-08-21 PHASE1
NCT05099172 RECRUITING
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation
Bayer
 2021-10-25 PHASE1; PHASE2
NCT07102095 COMPLETED
Hepatic Insufficiency; Liver Diseases; Pharmacokinetics; Drug Metabolism
Bayer
 2025-07-24 PHASE1
NCT06360211 COMPLETED
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers
Bayer
 2024-04-17 PHASE1
NCT06348888 COMPLETED
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers
Bayer
 2024-04-10 PHASE1
NCT06378658 COMPLETED
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers
Bayer
 2024-03-29 PHASE1
NCT06329895 COMPLETED
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers
Bayer
 2024-03-25 PHASE1
NCT06221475 COMPLETED
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers
Bayer
 2024-01-25 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Sevabertinib (BAY 2927088) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sevabertinib (BAY 2927088) is a non-covalent, reversible tyrosine kinase inhibitor that selectively binds to mutant human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR), thereby blocking downstream oncogenic signal transduction and suppressing tumor cell proliferation. By specifically inhibiting exon 20 insertion mutants and related oncogenic variants, this targeted activity suppresses tumor growth in clinical conditions such as advanced non-small cell lung cancer and HER2-mutant solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.