The compounds presented are investigational or are being investigated for uses that have not been approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities. This information is presented only for purposes of providing a general overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved uses.

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Sevabertinib (BAY 2927088)

See how this compound is being investigated across Bayer’s oncology pipeline

Explore the tumor types, areas of research, and clinical trials associated with this investigational compound.

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Compound Overview

Human epidermal growth factor receptor 2 (HER2) is a protein essential for the regulation of cell proliferation, survival, differentiation, and migration. When mutations occur, the altered HER2 protein drives the growth and spread of cancer.1-4

Lung cancer patients with HER2 mutations are underserved by current therapeutic options, with the need for oral targeted therapies that are well tolerated and efficacious.5,6

Sevabertinib (BAY 2927088) is an oral and reversible tyrosine-kinase inhibitor (TKI) targeting difficult-to-treat, activating HER2 mutations. It is currently being investigated in patients with advanced non–small cell lung cancer (NSCLC) and in patients with other advanced solid tumors.1,2,3,7

Tumor Types

Lung cancer
Solid tumors

Area of Research

HER2 signaling

Clinical Trials

Tumor Type(s)

Phase

Status

Description

NCT Number

Lung Cancer

I, II

Now Enrolling

An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non–small Cell Lung Cancer (NSCLC) Harboring an EGFR and/or HER2 Mutation

NCT05099172

Solid Tumors

II

Now Enrolling

A Phase 2 Open-Label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-Activating Mutations

NCT06760819

Lung Cancer

III

Now Enrolling

A Phase 3 Open-Label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-Line Therapy in Patients With Locally Advanced or Metastatic Non–small Cell Lung Cancer (NSCLC) With HER2-Activating Mutations

NCT06452277

Bayer's Oncology Pipeline Brochure

Explore a comprehensive overview of Bayer's oncology pipeline, including investigational compounds, clinical trials, and areas of research.

Download BrochurePDF (1.45 MB)

The ongoing clinical trials listed on this website represent a comprehensive overview of Bayer's clinical pipeline in Oncology, including Bayer-sponsored research and collaborative research with academic centers, cooperative groups, and other global institutions.