A Study to Learn More About How Well Treatment With BAY2927088 Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
- Registration Number
- NCT06760819
- Lead Sponsor
- Bayer
- Brief Summary
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
In this trial, the researchers want to learn how well BAY2927088 works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).
Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.
The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.
The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.
During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 111
- Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; other solid tumor cancer, excluding NSCLC)
- Participant must be ≥18 years of age or over the legal age of consent
- Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
- Documented activating HER2 mutation
- At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria
- Primary diagnosis of non-small cell lung cancer (NSCLC)
- Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
- Active brain metastases
- Uncontrolled, severe, intercurrent illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BAY2927088 BAY2927088 Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until disease progression per RECICST 1.1, unacceptable toxicity, or until any other withdrawal criteria. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BID: twice a day
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1 by BICR. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \<10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) per RECIST 1.1 as assessed by BICR From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first DOR is defined as the time from date of first documented complete or partial response (if confirmed) until the earliest date of progressive disease (PD) per RECIST 1.1 as assessed by BICR, or death from any cause, whichever occurs first. PD is defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)Time to response (TTR) per RECIST 1.1 as assessed by BICR From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years) TTR is defined as the time from the start of study treatment until the date of first documented complete or partial response (if confirmed) per RECIST 1.1 as assessed by BICR.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)ORR per RECIST 1.1 as assessed by the investigator From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first ORR is defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per RECIST 1.1 by investigator.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first Defined as the time from date of start of treatment until the earliest date of PD per RECIST 1.1 as assessed by the BICR, or death from any cause, whichever occurs first.
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first DCR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD), by the BICR per RECIST 1.1. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
DCR ≥12 weeks per RECIST 1.1 as assessed by BICR From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD (for at least 12 weeks following the first study intervention), by the BICR per RECIST 1.1.
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD, by the investigator per RECIST 1.1.
DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD (for at least 12 weeks following the first study intervention), by the investigator per RECIST 1.1.
Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first Defined as the time from date of start of treatment until the earliest date of PD per RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs first
DOR per RECIST 1.1 as assessed by the investigator From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first DOR is defined as the time from date of first documented complete or partial response (if confirmed) until the earliest date of PD per RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs first.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity, including number of participants who discontinue study treatment due to an AE From first participant enrolled until up to 30 days after the last administration of study treatment From first administration of study intervention up to 30 days (+5 days) after the last dose of study intervention.
Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL) Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years) The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the change from baseline in global health status/QoL.
EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30TTR per RECIST 1.1 as assessed by the investigator From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years) TTR is defined as the time from the start of study treatment until the date of first documented complete or partial response (if confirmed) per RECIST 1.1 as assessed by the investigator.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1Overall survival (OS) From start of study intervention until death from any cause, or end of study (up to approximately 3 years), whichever comes first Defined as the time from the start of study treatment to the date of death from any cause.
Time to deterioration in EORTC QLQ-C30 physical functioning domain score Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years) The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the time to deterioration in the physical functioning domain score.
EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30Change from baseline in EORTC QLQ-C30 physical functioning domain score Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years) The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the change from baseline in the physical functioning domain score.
EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Related Research Topics
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Trial Locations
- Locations (51)
Hopitaux Universitaires de Geneve
🇨🇭Genève, Switzerland
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
City of Hope - Duarte Cancer Center
🇺🇸Duarte, California, United States
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
🇺🇸Fort Myers, Florida, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
🇺🇸Detroit, Michigan, United States
Profound Research LLC
🇺🇸Farmington Hills, Michigan, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology
🇺🇸Seattle, Washington, United States
UW Health - UW Carbone Cancer Center - Medical Oncology Clinic
🇺🇸Madison, Wisconsin, United States
Blacktown Cancer & Haematology Centre
🇦🇺Blacktown, New South Wales, Australia
Macquarie University Hospital
🇦🇺Sydney, New South Wales, Australia
ICON Cancer Centre - Southport
🇦🇺Southport, Queensland, Australia
Queen Elizabeth II Health Sciences Centre - Victoria General Site
🇨🇦Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre - Glen Site
🇨🇦Montreal, Quebec, Canada
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Rigshospitalet - Kræftbehandling
🇩🇰Copenhagen OE, Denmark
Odense University Hospital - Oncology Department
🇩🇰Odense C, Denmark
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
🇫🇷Bordeaux, France
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
🇫🇷Brest, France
Centre Oscar Lambret - Service Oncologie
🇫🇷Lille, France
Centre Hospitalier Lyon Sud - Service oncologie medicale
🇫🇷Pierre-Benite, France
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
🇫🇷Villejuif Cedex, France
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
🇮🇹Milano, Italy
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
🇮🇹Reggio Emilia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
🇮🇹Roma, Italy
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
🇯🇵Kashiwa, Chiba, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
🇪🇸Madrid, Navarra, Spain
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
🇪🇸Barcelona, Spain
Fundacion Jimenez Diaz (Clinica de la Concepcion)
🇪🇸Madrid, Spain
Inselspital Bern - Universitätsklinik für Medizinische Onkologie
🇨🇭Bern, Switzerland
Univestitätsspital Zürich (USZ)
🇨🇭Zürich, Switzerland