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: Active Phase 1 study of Advanced Non-Small-Cell Lung Cancer and HER2 Mutation, sponsored by Bayer.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05099172 still lists
NCT05099172 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 366-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target.
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 names 20 study sites across 19 states, led by 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.
Where NCT05099172's enrollment target sits among peer trials
370 10th of 22 higher than 13 of 22 other Advanced Non-Small-Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Non-Small-Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
RECRUITING · Phase 1
-
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
ACTIVE NOT RECRUITING · Phase 1
-
AZD9291 in Combination With Ascending Doses of Novel Therapeutics
ACTIVE NOT RECRUITING · Phase 1
-
A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants
COMPLETED · Phase 1
-
Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02332668 · 370 participants · Phase 1
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
- NCT04284436 · 370 participants · NA
Study in Parkinson Disease of Exercise
- NCT05026749 · 370 participants · Phase 3
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
- NCT05125016 · 370 participants · Phase 1
A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI