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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05099172
Other study ID # 21607
Secondary ID 2023-503795-24-0
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 25, 2021
Est. completion date November 30, 2027

Study information

Verified date May 2024
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Is FDA regulated No
Health authority
Study type Interventional

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 370
Est. completion date November 30, 2027
Est. primary completion date November 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 one of the groups (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 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable. - 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 - 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: 1. 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. 2. Platelets = 100 × 10^9 cells/L. 3. 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: a. 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: 1. Total bilirubin = 1.5 × ULN (or = 3 X ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis). 2. Aspartate transaminase and alanine transaminase = 2.5 × ULN (or = 5 × ULN if due to liver involvement by tumor). Exclusion Criteria: - 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). - History of spinal cord compression or brain metastases with the following exceptions: 1. 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 BAY 2927088 are eligible to enroll in Dose Escalation and Backfill. 2. Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion/Extension (with the exception of Group G) 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 BAY2927088. 3. 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. 4. Expansion Group G only: 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 BAY2927088 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: 1. 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 2. Active Hepatitis B infection (positive for Hepatitis B surface antigen [HbsAg]) and Hepatitis B virus [HBV] DNA). 3. 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. Strong CYP3A4 inhibitors and inducers are prohibited during the study and until Safety FU (follow up) visit.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY2927088_formulation A
Oral administration
BAY2927088_formulation B_1
Oral administration
BAY2927088_formulation B_2
Oral administration

Locations

Country Name City State
Belgium UZ Leuven Gasthuisberg Leuven
Belgium AZ Delta | Clinical Trial Center - Pneumology Roeselare
Brazil Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica Natal Rio Grande Do Norte
Brazil Hospital de Base | Integrated Research Center São José do Rio Preto Sao Paulo
Brazil Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department Sao Paulo
China Beijing Cancer Hospital Beijing
China Beijing Hospital Beijing
China Hunan Cancer Hospital Changsha Hunan
China West China Hospital Sichuan University Chengdu Sichuan
China Fujian Cancer Hospital Fuzhou Fujian
China Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Qilu Hosp., Shandong Univ. Jinan Shandong
China Shandong University - Shandong Cancer Hospital Jinan
China NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing Jiangsu
China Shanghai Chest Hospital, Shanghai Jiaotong University Shanghai
China Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province Taizhou
China Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech Wuhan Hubei
France Institut Bergonié - Unicancer Nouvelle Aquitaine Bordeaux Cedex
France Centre Léon Bérard Lyon
France Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord Marseille
France Hôpital Nord Laennec - Oncologie médicale thoracique et digestive Nantes
France Institut Curie - Ulm - Paris PARIS cedex 5
France Institut de Cancérologie de l'Ouest - Saint Herblain Saint-Herblain
France Institut Gustave Roussy - Département de Médecine Oncologique Villejuif Cedex
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Hong Kong United Oncology Centre Kowloon
Hong Kong Prince of Wales Hospital Shatin
Israel Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva
Israel Chaim Sheba Medical Center Ramat Gan
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano Lombardia
Italy IRCCS Istituto Europeo di Oncologia s.r.l. (IEO) Milano Lombardia
Italy Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano Lombardia
Italy Istituto Nazionale Tumori IRCCS Fondazione G.Pascale Napoli Campania
Italy A.O.U. di Parma Parma Emilia-Romagna
Italy IRCCS Centro di Riferimento Oncologico (CRO) Pordenone Friuli-Venezia Giulia
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio
Italy A.O.U. San Luigi Gonzaga Torino Piemonte
Italy Azienda Ospedaliera Universitaria Integrata Verona (AOUI) Verona
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan National Hospital Organization Shikoku Cancer Center Matsuyama Ehime
Japan Aichi Cancer Center Hospital Nagoya Aichi
Japan Okayama University Hospital Okayama-city Okayama
Japan Osaka International Cancer Institute Osaka
Japan Kindai University Hospital Osakasayama-shi
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Shizuoka Cancer Center Sunto Shizuoka
Japan Kanagawa Cancer Center Yokohama Kanagawa
Japan Tottori University Hospital Yonago Tottori
Korea, Republic of Chungbuk National University Hospital Cheongju-si Chungcheongbugdo
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggido
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of St.Vincent's Hospital Suwon-si Gyeonggido
Netherlands Nederlands Kanker Instituut Amsterdam
Netherlands Radboud University Medical Center | Afdeling Interne Geneeskunde Nijmegen
Netherlands Erasmus Medisch Centrum Rotterdam
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital Weteranow Lodz
Portugal CHULN - H. Sta.Maria (Centro de Investigacao Clinica) Lisboa
Portugal START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa Norte Lisbon Lisboa
Portugal IPO Porto Porto
Singapore Curie Oncology Singapore
Singapore National Cancer Center Singapore Singapore
Singapore National University Hospital Singapore
Spain Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona
Spain Hospital Quiron Dexeus Barcelona
Spain Institut Català d'Oncologia Hospitalet Hospitalet de Llobregat Barcelona
Spain Centro Integral Oncológico Clara Campal Madrid
Spain Fundacion Jimenez Diaz (Clinica de la Concepcion) Madrid
Spain Hospital Universitario Virgen de la Victoria | Oncology Málaga
Spain Hospital Universitari i Politècnic La Fe Valencia
Taiwan Chung Shan Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Chi-Mei Medical Center, Liouyine Tainan
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Medical University (TMU) - Shuang Ho Hospital (SHH) Taipei
Taiwan Chang Gung Memorial Hospital at Linkou Taoyuan
United States Emory University Atlanta Georgia
United States The Center for Cancer and Blood Disorders Bethesda Maryland
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States Henry Ford Health System | Brigitte Harris Cancer Pavilion Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States City of Hope-Cancer Department Duarte California
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Tennessee Oncology Nashville Tennessee
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  China,  France,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Singapore,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-emergent adverse events (TEAEs) Up to 30 days after the last administration of study treatment
Primary Number of participants with treatment-emergent serious adverse events (TESAEs) Up to 30 days after the last administration of study treatment
Primary Severity of TEAEs Up to 30 days after the last administration of study treatment
Primary Severity of TESAEs Up to 30 days after the last administration of study treatment
Primary Number of participants who discontinue study treatment due to an AE About 4 years (Up to the end of study treatment)
Primary 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) At the end of Cycle 1 of a 21-day cycle
Primary 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) At the end of Cycle 1 of a 21-day cycle
Primary Cmax of BAY2927088 Cmax: Maximum/peak concentration Cycle 1, Day 1 (Cycle duration is 21 days)
Primary 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) Cycle 1, Day 1 (Cycle duration is 21 days)
Primary 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. Cycle 1, Day 1 (Cycle duration is 21 days)
Primary Cmax,md of BAY2927088 Cmax,md: Cmax after multiple dose administrations Cycle 1, Day 15 (Cycle duration is 21 days)
Primary AUC(0-24)md of BAY2927088 for QD AUC(0-24)md: AUC(0-24) after multiple dose administrations Cycle 1, Day 15 (Cycle duration is 21 days)
Primary AUC(0-12)md of BAY2927088 for BID If applicable AUC(0-12)md: AUC(0-12) after multiple dose administrations Cycle 1, Day 15 (Cycle duration is 21 days)
Primary 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 From the start of the study treatment up to 12 months
Secondary Overall response rate (ORR) as per RECIST v1.1 by investigator assessment RECIST v1.1: Response Evaluation Criteria in Solid Tumors, version 1.1 About 4 years
Secondary Recommended phase 2 dose (RP2D) of BAY2927088 About 1.5 years
Secondary ORR per RECIST v1.1 by Investigator assessment in extension part From the start of the study treatment up to 12 months
Secondary Disease control rate (DCR) per RECIST v1.1 by Investigator assessment and BICR in extension part From the start of the study treatment up to 12 months
Secondary Duration of response (DOR) per RECIST 1.1 by Investigator assessment and BICR in extension part From the start of the study treatment up to 12 months
Secondary Progression-free survival (PFS) per RECIST 1.1 by Investigator assessment and BICR in extension part From the start of the study treatment up to 12 months
Secondary Overall survival (OS) in extension part From the start of the study treatment up to 12 months
Secondary Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity in extension part Up to 30 days after the last administration of study treatment
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