Ozmosi | BAY-3498264 Drug Profile
Drug Profile
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BAY-3498264

Alternative Names: BAY-3498264, BAY 3498264, BAY3498264
Clinical Status: Active
Latest Update: 2026-08-26
Latest Update Note: Clinical Trial Update

Product Description

A potent and selective small molecule oral inhibitor of the SOS1 and RAS interaction. In KRAS G12C mutant cells, BAY 3498264 inhibits the rebound of phospho-ERK induced by sotorasib, achieving a more prolonged ERK phosphorylation inhibition when combined. Additionally, in in vitro proliferation assays, combining BAY 3498264 with various MAPK pathway inhibitors demonstrates marked combination effect as compared to single agent MAPK inhibition. The combination of BAY 3498264 with sotorasib in KRAS G12C mutant CDX and PDX models in vivo is well tolerated and exhibits combination benefit, enhancing both the depth and duration of response over sotorasib alone. (Sourced from: https://aacrjournals.org/cancerres/article/85/8_Supplement_1/4373/760909)

Mechanisms of Action: SOS1 Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: N/A

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Company: Bayer
Company Location:
Company Founding Year: 1863
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for BAY-3498264

Countries in Clinic: Australia, Denmark, Italy, Spain, United Kingdom

Active Clinical Trial Count: 1

Recent & Upcoming Milestones

Highest Development Phases

Phase 1: Heart Block|Heart Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT06659341

NCT06659341

P1

Recruiting

Heart Cancer|Heart Block

2027-04-26

12%

2026-08-27

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

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