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)

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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, 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 BAY 2927088

• The (average) highest level of BAY 2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part

• How well does BAY 2927088 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 BAY 2927088 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 feeling and what adverse events they are having.

An adverse event is considered "serious" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• EGFR Mutation
• Lung Neoplasms

• NCT number: NCT05099172
• Study type: Interventional
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact@bayer.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 25, 2021
• Completion date: November 30, 2027