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)

• Status: Not yet recruiting
• Trial end date: 2025-12-31

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. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer.

This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations.

The main aims of this study are to find for BAY2927088

• how safe BAY2927088 is

• how it affects the body (also referred to as tolerability)

• how BAY2927088 moves into, through and out of the body

• the maximum amount of BAY2927088 that the participants can take without too many side effects.

The researchers will also study the action of BAY2927088 against the cancer. This study will have three parts. The first part will help find the most appropriate dose that can be given in the third part.

Each participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next.

The participants of the second, so called Backfill part will be assigned any specific dose that has already been tested during Part 1 and found to be safe.

The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts.

During the study, the participants will take the study treatment in 3 week periods called "cycles". They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle.

During the study, the study team will:

• take blood and urine samples

• take regular CT or MRI scans to check if the participants' cancer has gotten better or worse

• check the participants' overall health and heart health

• ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

• Phase: Phase 1

Details

• Lead Sponsor: Bayer