account_circleRecruiting
Advanced solid tumors, HER2 mutation
Bayer Identifier:
22752
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2024-517419-62-00
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)
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
111Trial Dates
February 2025 - October 2027Phase
Phase 2Could I Receive a placebo
NoProducts
BAY2927088Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale | Bordeaux, 33000, France |
Not yet recruiting | SCRI Oncology Partners | Nashville, 37203, United States |
Not yet recruiting | National Cancer Center Hospital East (NCCHE) - Kashiwa Campus | Kashiwa, 277-8577, Japan |
Not yet recruiting | Centre Oscar Lambret - Service Oncologie | Lille, 59000, France |
Recruiting | Beijing Cancer Hospital | Beijing, 100142, China |
Recruiting | Rigshospitalet - Kræftbehandling | Copenhagen OE, 2100, Denmark |
Not yet recruiting | Princess Margaret Cancer Centre – University Health Network - Department of Medical Oncology and Hematology | Toronto, M5G 2C4, Canada |
Not yet recruiting | Queen Elizabeth II Health Sciences Centre - Victoria General Site | Halifax, B3H 1V7, Canada |
Recruiting | University of Texas MD Anderson Cancer Center | Houston, 77030-4000, United States |
Not yet recruiting | Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals | L'Hospitalet de Llobregat, 08908, Spain |
Not yet recruiting | Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid | Madrid, 28027, Spain |
Not yet recruiting | Fundacion Jimenez Diaz (Clinica de la Concepcion) | Madrid, 28040, Spain |
Not yet recruiting | Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO) | Barcelona, 8035, Spain |
Not yet recruiting | McGill University Health Centre – Glen Site | Montreal, H4A 3J1, Canada |
Not yet recruiting | Aarhus University Hospital | Aarhus N, 8200, Denmark |
Not yet recruiting | Odense University Hospital - Oncology Department | Odense C, 5000, Denmark |
Withdrawn | University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology | Seattle, 98195-0001, United States |
Not yet recruiting | Fudan University Shanghai Cancer Center | Shanghai, 200000, China |
Not yet recruiting | Hunan Cancer Hospital | Changsha, 410013, China |
Recruiting | Asan Medical Center | Seoul, 05505, Korea,_republic_of |
Not yet recruiting | Samsung Medical Center | Seoul, 06351, Korea,_republic_of |
Not yet recruiting | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Not yet recruiting | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Not yet recruiting | UW Health - UW Carbone Cancer Center - Medical Oncology Clinic | Madison, 53792, United States |
Not yet recruiting | City of Hope - Duarte Cancer Center | Duarte, 91010, United States |
Not yet recruiting | Centre Hospitalier Lyon Sud - Service oncologie medicale | Pierre-Benite, 69310, France |
Recruiting | CHU Brest - Hopital La Cavale Blanche - service oncologie medicale | Brest, 29200, France |
Not yet recruiting | Hokkaido University Hospital | Sapporo, 060-8648, Japan |
Not yet recruiting | Aichi Cancer Center Hospital | Nagoya, 464-8681, Japan |
Not yet recruiting | The Cancer Institute Hospital of JFCR | Koto-ku, 135-8550, Japan |
Not yet recruiting | Kindai University Hospital | Osakasayama, 589-8511, Japan |
Not yet recruiting | National Cancer Center Hospital | Chuo-ku, 104-0045, Japan |
Not yet recruiting | Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale | Reggio Emilia, 42123, Italy |
Not yet recruiting | Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1 | Milano, 20133, Italy |
Not yet recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica | Roma, 00168, Italy |
Not yet recruiting | Zhongshan Hospital, Fudan University | Shanghai, 200032, China |
Not yet recruiting | Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine | Hangzhou, 310016, China |
Not yet recruiting | Macquarie University Hospital | Sydney, 2109, Australia |
Not yet recruiting | Dana-Farber Cancer Institute | Boston, 02215, United States |
Not yet recruiting | Peking University First Hospital | Beijing, 100034, China |
Not yet recruiting | Univestitätsspital Zürich (USZ) | Zürich, 8091, Switzerland |
Not yet recruiting | Inselspital Bern - Universitätsklinik für Medizinische Onkologie | Bern, 3010, Switzerland |
Not yet recruiting | Profound Research LLC | Farmington Hills, 48334, United States |
Not yet recruiting | Hopitaux Universitaires de Geneve | Genève, 1205, Switzerland |
Not yet recruiting | ICON Cancer Centre - Southport | Southport, 4215, Australia |
Not yet recruiting | Blacktown Cancer & Haematology Centre | Blacktown, 2148, Australia |
Withdrawn | Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit | Detroit, 48202, United States |
Not yet recruiting | Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus | Fort Myers, 33908, United States |
Not yet recruiting | Cleveland Clinic | Cleveland, 44195, United States |
Not yet recruiting | University of Alabama at Birmingham | Birmingham, 35233, United States |
Primary Outcome
- Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICRORR 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)date_rangeTime Frame: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
Secondary Outcome
- Duration of response (DOR) per RECIST 1.1 as assessed by BICRDOR 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)date_rangeTime Frame: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
- Time to response (TTR) per RECIST 1.1 as assessed by BICRTTR 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)date_rangeTime Frame:From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
- ORR per RECIST 1.1 as assessed by the investigatorORR 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 1.1date_rangeTime Frame: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
- Disease control rate (DCR) per RECIST 1.1 as assessed by BICRDCR 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.date_rangeTime Frame: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 ≥12 weeks per RECIST 1.1 as assessed by BICRDefined 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.date_rangeTime Frame: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
- Progression-free survival (PFS) per RECIST 1.1 as assessed by BICRDefined 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.date_rangeTime Frame: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
- Disease control rate (DCR) per RECIST 1.1 as assessed by the investigatorDefined as the proportion of participants with a best overall response of confirmed CR or PR or SD, by the investigator per RECIST 1.1.date_rangeTime Frame: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 ≥12 weeks per RECIST 1.1 as assessed by the investigatorDefined 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.date_rangeTime Frame: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
- Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigatorDefined 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 firstdate_rangeTime Frame: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 per RECIST 1.1 as assessed by the investigatorDOR 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 1.1date_rangeTime Frame: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
- TTR per RECIST 1.1 as assessed by the investigatorTTR 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 1.1date_rangeTime Frame:From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
- Overall survival (OS)Defined as the time from the start of study treatment to the date of death from any cause.date_rangeTime Frame:From start of study intervention until death from any cause, or end of study (up to approximately 3 years), whichever comes first
- Number 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 AEFrom first administration of study intervention up to 30 days (+5 days) after the last dose of study intervention.date_rangeTime Frame:From first participant enrolled until up to 30 days after the last administration of study treatment
- Time to deterioration in EORTC QLQ-C30 physical functioning domain scoreThe 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 30date_rangeTime Frame:Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
- Change from baseline in EORTC QLQ-C30 physical functioning domain scoreThe 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 30date_rangeTime Frame:Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
- Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)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 30date_rangeTime Frame:Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Single Group AssignmentTrial Arms
1