AzTrials
AzTrials

Advanced Non-small Cell Lung CancerPhase 1/2NCT05099172

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 1/2 study testing BAY2927088_formulation A, BAY2927088_formulation B_1 and BAY2927088_formulation B_2 in people with Advanced Non-small Cell Lung Cancer and EGFR Mutation, run by Bayer at 94 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BAY2927088_formulation A, BAY2927088_formulation B_1 and BAY2927088_formulation B_2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
94 sitesin 16 countries
Study dates
25 Oct 2021to 30 Jun 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).
  • Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.
  • Note: Except for participants eligible for Group F, Group H and Group I (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease.
  • Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.
  • Measurable disease by RECIST v1.1 (or by RANO-BM for participants in Expansion Groups G and H) with at least one lesion that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements.
  • Documented activating EGFR and/or HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States [US] sites) or an equally accredited (outside of the US) local laboratory.
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Minimum life expectancy of 12 weeks.
  • Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:
  • Hemoglobin ≥ 9.0 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing.
  • Platelets ≥ 100 × 10^9 cells/L.
  • Absolute neutrophil count ≥ 1.5 ×10^9 cells/L. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing.
  • Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:
  • Estimated glomerular filtration rate (eGFR) > 50 mL/min per 1.73 m^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula.
  • Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:
  • Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis).
  • Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor).

Who cannot join

  • Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.
  • Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.
  • Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.
  • Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.
  • Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.
  • Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).
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  • History of spinal cord compression or brain metastases with the following exceptions:
  • Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of sevabertinib are eligible to enroll in Dose Escalation and Backfill.
  • Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion/Extension (with the exception of Groups G and H) if all of the following criteria are met:
  • there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
  • Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib.
  • Participants with history of spinal cord compression >3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic.
  • Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg/day dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible.
  • History of congestive heart failure (CHF) Class >II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec).
  • Participants with:
  • Known human immunodeficiency virus (HIV), except as noted below: Participants with history of HIV infection are eligible at the Investigator's discretion provided that: • CD4+ T-cell (CD4+) counts are ≥ 350 cells/uL • The participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to the start of study drug and has an HIV viral load less than 400 copies/mL prior to start of the study treatment • The ART being used does not contain strong inducers or inhibitors of CYP3A4, and is not anticipated to cause overlapping toxicities with study drug • The participant has not had an opportunistic infection within the past 12 months
  • Active Hepatitis B infection (positive for Hepatitis B surface antigen [HbsAg]) and Hepatitis B virus [HBV] DNA).
  • Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay).
  • NOTE: Participants with history of chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.
  • Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug.

Trial locations and contacts

94 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

0018888422937

clinical-trials-contact@bayer.com

94 sites in 16 countries

China14 sites

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142

    Active, not recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Active, not recruiting

  • Hunan Cancer Hospital - Oncology Department

    Changsha, Hunan, 410013

    Active, not recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Active, not recruiting

  • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

    Hangzhou, Zhejiang, 310016

    Active, not recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Active, not recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Terminated

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Terminated

  • Shandong University - Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Active, not recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Active, not recruiting

  • Shanghai Chest Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200030

    Active, not recruiting

  • Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province

    Taizhou, Jiangsu, 317000

    Active, not recruiting

  • Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech

    Wuhan, Hubei, 430023

    Active, not recruiting

Other trials in China

United States11 sites, 1 recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Active, not recruiting

  • The Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

    Withdrawn

  • Dana-Farber Cancer Institute - Oncology Department

    Boston, Massachusetts, 02215

    Completed

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Withdrawn

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

    Detroit, Michigan, 48202

    Completed

  • City of Hope - Duarte Cancer Center

    Duarte, California, 91010

    Completed

  • Inova Schar Cancer Insitute - Inova Fairfax Hospital

    Fairfax, Washington, 22031

    Withdrawn

  • Virginia Cancer Specialists, PC - Fairfax

    Fairfax, Washington, 22031

    Completed

  • Banner MD Anderson Cancer Center at Banner Gateway Medical Center

    Gilbert, Arizona, 85234

    Completed

  • The University of Texas MD Anderson Cancer Center - Texas Medical Center

    Houston, Texas, 77030

    Active, not recruiting

  • Tennessee Oncology - Nashville Centennial Clinic

    Nashville, Tennessee, 37203

    Recruiting

Other trials in United States

Japan11 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Active, not recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Active, not recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

    Completed

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

    Active, not recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Terminated

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Active, not recruiting

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

    Active, not recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Active, not recruiting

  • Shizuoka Cancer Center

    Sunto, Shizuoka, 411-8777

    Completed

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

    Active, not recruiting

  • Tottori University Hospital

    Yonago, Tottori, 683-8504

    Completed

Other trials in Japan

Italy9 sites

  • Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati

    Aviano, Friuli Venezia Giulia, 33081

    Active, not recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

    Milan, Lombardy, 20133

    Active, not recruiting

  • Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative

    Milan, Lombardy, 20141

    Completed

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale

    Naples, Campania, 80131

    Withdrawn

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica

    Orbassano, Piedmont, 10043

    Active, not recruiting

  • Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica

    Parma, Emilia-Romagna, 43126

    Active, not recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I

    Rome, Lazio, 00128

    Active, not recruiting

  • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

    Rozzano, Lombardy, 20089

    Active, not recruiting

  • Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia

    Verona, Veneto, 37134

    Completed

Other trials in Italy

France7 sites

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    Bordeaux, New Aquitaine, 33000

    Completed

  • UNICANCER - Centre Leon-Berard (CLB) - Medical oncology

    Lyon, Auvergne-Rhône-Alpes, 69373

    Active, not recruiting

  • AP-HM - Hopital de la Timone - Centre d'Essais en Cancerologie

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

    Withdrawn

  • Hopital Nord Laennec - Oncologie medicale thoracique et digestive

    Nantes, Pays de la Loire Region, 44093

    Active, not recruiting

  • Institut Curie - Paris - Oncologie medicale

    Paris, Île-de-France Region, 75248

    Completed

  • Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale

    Saint-Herblain, Pays de la Loire Region, 44800

    Active, not recruiting

  • Gustave Roussy - Departement Oncologie-Radiotherapie

    Villejuif, Île-de-France Region, 94805

    Completed

Other trials in France

South Korea7 sites

  • Chungbuk National University Hospital | Hematology and Oncology

    Chungcheongbuk-do, North Chungcheong, 28644

    Active, not recruiting

  • Seoul National University Hospital | Oncology

    Jongno -Gu, Seoul, 03080

    Active, not recruiting

  • Seoul National University Bundang Hospital | Hematology and Medical Oncology

    Seongnam-si, Gyeonggi-do, 13620

    Completed

  • Severance Hospital | Oncology

    Seoul, 03722

    Active, not recruiting

  • Asan Medical Center | Oncology

    Seoul, 05505

    Active, not recruiting

  • Samsung Medical Center | Oncology

    Seoul, 06351

    Active, not recruiting

  • St Vincent's Hospital | Oncology

    Suwon, Gyeonggi-do, 16247

    Active, not recruiting

Other trials in South Korea

Spain7 sites

  • Hospital Universitari Dexeus Grupo Quironsalud | Oncologia

    Barcelona, 08028

    Active, not recruiting

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035

    Active, not recruiting

  • Institut Catala D'oncologia | Hospitalet | Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908

    Active, not recruiting

  • Hospital Universitario Fundacion Jimenez Diaz | Oncologia

    Madrid, 28040

    Active, not recruiting

  • Hospital Universitario Hm Sanchinarro | Oncologia

    Madrid, 28050

    Completed

  • Hospital Universitario Virgen De La Victoria | Oncologia

    Málaga, 29010

    Withdrawn

  • Hospital Universitario Y Politecnico La Fe | Oncologia

    Valencia, 46026

    Active, not recruiting

Other trials in Spain

Taiwan7 sites

  • Chung Shan Medical University Hospital

    Taichung, 402306

    Withdrawn

  • Taichung Veterans General Hospital

    Taichung, 40705

    Active, not recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Active, not recruiting

  • Chi-Mei Medical Center, Liouyine

    Tainan, 73657

    Active, not recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Active, not recruiting

  • Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)

    Taipei, 23561

    Withdrawn

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305

    Active, not recruiting

Other trials in Taiwan

Brazil3 sites

  • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

    Natal, Rio Grande do Norte, 59040-000

    Active, not recruiting

  • Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia

    São José do Rio Preto, São Paulo, 15090-000

    Withdrawn

  • Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department

    São Paulo, 05651-901

    Withdrawn

Other trials in Brazil

Hong Kong3 sites, 1 recruiting

  • Prince of Wales Hospital

    Hong Kong, Hong Kong SAR, 00000

    Active, not recruiting

  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR, 00000

    Active, not recruiting

  • Hong Kong United Oncology Centre

    Kowloon, 00000

    Recruiting

Other trials in Hong Kong

Netherlands3 sites

  • Nederlands Kanker Instituut

    Amsterdam, North Holland, 1066 CX

    Active, not recruiting

  • Radboud University Medical Center | Afdeling Interne Geneeskunde

    Nijmegen, Gelderland, 6500 HB

    Withdrawn

  • Erasmus University Medical Center | Research Department - Lung Diseases

    Rotterdam, South Holland, 3015 GD

    Completed

Other trials in Netherlands

Portugal3 sites, 1 recruiting

  • START Research Portugal

    Lisbon, 1649-028

    Withdrawn

  • Hospital Santa Maria | Centro de Investigacao Clinica

    Lisbon, 1649-035

    Withdrawn

  • IPO Porto

    Porto, 4200-072

    Recruiting

Other trials in Portugal

Singapore3 sites

  • National University Hospital Medical Centre

    Singapore, 119074

    Active, not recruiting

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583

    Active, not recruiting

  • Curie Oncology | Mount Elizabeth Novena

    Singapore, 329563

    Active, not recruiting

Other trials in Singapore

Belgium2 sites

  • UZ Leuven Gasthuisberg - Pneumology Department

    Leuven, Flemish Brabant, 3000

    Active, not recruiting

  • AZ Delta | Clinical Trial Center - Pneumology

    Roeselare, West Flanders, 8800

    Active, not recruiting

Other trials in Belgium

Israel2 sites

  • Rabin Medical Center | Beilinson Campus

    Petah Tikva, Central District, 4941492

    Completed

  • Chaim Sheba Medical Center

    Ramat Gan, Tel Aviv, 5262000

    Completed

Other trials in Israel

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

    Withdrawn

  • Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi

    Lodz, Łódź Voivodeship, 92-213

    Withdrawn

Other trials in Poland

About this study

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

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, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.

Read more

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 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part
  • How well does BAY2927088 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 BAY2927088 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.

Being tested
BAY2927088_formulation A, BAY2927088_formulation B_1, BAY2927088_formulation B_2, BAY2927088_formulation B_3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY2927088_formulation ADrug

    Oral administration

  • BAY2927088_formulation B_1Drug

    Oral administration

  • BAY2927088_formulation B_2Drug

    Oral administration

  • BAY2927088_formulation B_3Drug

    Oral administration

Study groups in NCT05099172
Study groupRoleWhat they receive
Dose escalationExperimentalDoses of BAY2927088 will be increased in a stepwise fashion up to the MTD or MAD.
Receives: Drug: BAY2927088_formulation A; Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2
BackfillExperimentalDose Escalation and Backfill run concurrently
Receives: Drug: BAY2927088_formulation A; Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2
Dose expansionExperimentalEight independent groups (group A, B1, B2, C, D, E, F, G, H, I, J) are planned. Dose Expansion may start at a dose level that has been evaluated in Escalation/Backfill in at least 9 participants and considered safe or at any other dose levels that are below the highest dose level that is considered safe.
Receives: Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2; Drug: BAY2927088_formulation B_3
Extension partExperimentalInitiation of the Extension part will depend on the benefit-risk profile observed during Dose Expansion. Additionally, enrollment may be prematurely terminated based on emerging data at the discretion of the Sponsor.
Receives: Drug: BAY2927088_formulation B_1; Drug: BAY2927088_formulation B_2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Measured: Up to 30 days after the last administration of study treatment

  2. Number of participants with treatment-emergent serious adverse events (TESAEs)

    Measured: Up to 30 days after the last administration of study treatment

  3. Severity of TEAEs

    Measured: Up to 30 days after the last administration of study treatment

  4. Severity of TESAEs

    Measured: Up to 30 days after the last administration of study treatment

  5. Number of participants who discontinue study treatment due to an AE

    Measured: About 4 years (Up to the end of study treatment)

  6. Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population)

    Measured: At the end of Cycle 1 of a 21-day cycle

  7. Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill)

    In Dose Escalation (including participants from Backfill)

    Measured: At the end of Cycle 1 of a 21-day cycle

  8. Cmax of BAY2927088

    Cmax: Maximum/peak concentration

    Measured: Cycle 1, Day 1 (Cycle duration is 21 days)

  9. AUC(0-24) of BAY2927088 for QD

    AUC: Area under the concentration vs. time curve. AUC(0-24): AUC from time 0 to 24 hours post dose. QD: Quaque die (once daily)

    Measured: Cycle 1, Day 1 (Cycle duration is 21 days)

  10. AUC(0-12) of BAY2927088 for BID

    If applicable. AUC(0-12): AUC from time 0 to 12 hours post dose. BID: Bis in die, 2 times daily.

    Measured: Cycle 1, Day 1 (Cycle duration is 21 days)

  11. Cmax,md of BAY2927088

    Cmax,md: Cmax after multiple dose administrations

    Measured: Cycle 1, Day 15 (Cycle duration is 21 days)

  12. AUC(0-24)md of BAY2927088 for QD

    AUC(0-24)md: AUC(0-24) after multiple dose administrations

    Measured: Cycle 1, Day 15 (Cycle duration is 21 days)

  13. AUC(0-12)md of BAY2927088 for BID

    If applicable AUC(0-12)md: AUC(0-12) after multiple dose administrations

    Measured: Cycle 1, Day 15 (Cycle duration is 21 days)

  14. Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension part

    Measured: From the start of the study treatment up to 12 months

Secondary outcomes (8)

  1. Overall response rate (ORR) as per RECIST v1.1 by investigator assessment

    RECIST v1.1: Response Evaluation Criteria in Solid Tumors, version 1.1

    Measured: About 4 years

  2. Recommended phase 2 dose (RP2D) of BAY2927088

    Measured: About 1.5 years

  3. ORR per RECIST v1.1 by Investigator assessment in extension part

    Measured: From the start of the study treatment up to 12 months

  4. Disease control rate (DCR) per RECIST v1.1 by Investigator assessment and BICR in extension part

    Measured: From the start of the study treatment up to 12 months

  5. Duration of response (DOR) per RECIST 1.1 by Investigator assessment and BICR in extension part

    Measured: From the start of the study treatment up to 12 months

  6. Progression-free survival (PFS) per RECIST 1.1 by Investigator assessment and BICR in extension part

    Measured: From the start of the study treatment up to 12 months

  7. Overall survival (OS) in extension part

    Measured: From the start of the study treatment up to 12 months

  8. Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity in extension part

    Measured: Up to 30 days after the last administration of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start25 Oct 2021
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
430 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099172
Sponsor's protocol ID
21607
Other IDs
2023-503795-24-00, 2021-003022-77, 2023
Status last verified
20 Oct 2026
First submitted
19 Oct 2021
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Expanded access
Available

Publications

  • Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, Fang Y, Lu S, Dong X, Wu L, Shinno Y, Daniele G, Yang TY, Kim HR, Ruiter G, Zhao J, Novello S, Miao L, Janne PA, Goto K, Ruttinger D, Descamps T, Brase JC, Bao W, Li R, Brega N, Grassi P, Girard N, Tan DS; SOHO-01 Investigators. Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Nov 6;393(18):1819-1832. doi: 10.1056/NEJMoa2511065. Epub 2025 Oct 17.

    PubMed 41104928

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BAY2927088_formulation A, BAY2927088_formulation B_1 and BAY2927088_formulation B_2 in people with Advanced Non-small Cell Lung Cancer and EGFR Mutation, run by Bayer at 94 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in China, United States, Japan, Italy, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (0018888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to 30 days after the last administration of study treatment). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05099172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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