Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05099172 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Advanced Non-Small-Cell Lung Cancer and HER2 Mutation, sponsored by Bayer.

Active
Registry status
Phase 1
Development phase
370
Enrollment target
20
Study locations

NCT05099172 is a Phase 1 study of Advanced Non-Small-Cell Lung Cancer and HER2 Mutation that is active but no longer recruiting, run by Bayer. The registered enrollment target is 370 participants, roughly in line with the 366-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 19 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05099172, a Phase 1 study of Advanced Non-Small-Cell Lung Cancer and HER2 Mutation, is active but no longer recruiting, sponsored by Bayer.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
370 participants
Enrollment target
20
Study locations

Study 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 BAY2927088 * The (average) highest level of BAY2927088

Conditions Studied

Advanced Non-Small-Cell Lung Cancer HER2 Mutation EGFR Mutation

Interventions

  • DRUG BAY2927088_formulation A
  • DRUG BAY2927088_formulation B_1
  • DRUG BAY2927088_formulation B_2

Study Locations (20)

Beijing Municipality

  • Beijing Cancer Hospital - Oncology Department - Beijing
  • Beijing Hospital - Beijing

Arizona

  • Banner MD Anderson Cancer Center at Banner Gateway Medical Center - Gilbert

California

  • City of Hope - Duarte Cancer Center - Duarte

Georgia

  • Emory Winship Cancer Institute - Atlanta

Maryland

  • The Center for Cancer and Blood Disorders - Bethesda

Massachusetts

  • Dana-Farber Cancer Institute - Oncology Department - Boston

Michigan

  • Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit - Detroit

New York

  • NYU Langone Hospital - Long Island - Urology - Mineola

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2021-10-25
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Bayer

591 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05099172

The ClinicalTrials.gov registry entry for NCT05099172 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 366-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Advanced Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which BAY2927088_formulation A is the first listed.

NCT05099172 reports 20 study locations spanning 19 distinct geographic areas - top geographies include Beijing Municipality, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT05099172 about?

NCT05099172 is a clinical study titled "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)". 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 pr...

What is the current status of trial NCT05099172?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 370 participants. The study started on 2021-10-25. Estimated completion is 2026-12-31.

What conditions does trial NCT05099172 study?

This clinical trial studies the following conditions: Advanced Non-Small-Cell Lung Cancer, HER2 Mutation, EGFR Mutation.

What interventions are being tested in trial NCT05099172?

The interventions under investigation include: BAY2927088_formulation A (DRUG), BAY2927088_formulation B_1 (DRUG), BAY2927088_formulation B_2 (DRUG).

Who is sponsoring clinical trial NCT05099172?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05099172 being conducted?

This trial has 20 study locations across Arizona, California, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Non-Small-Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Advanced Non-Small-Cell Lung Cancer

All registered trials for this condition

HER2 Mutation

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.