Trial Condition(s):
Advanced solid tumors, HER2 mutation
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) (panSOHO)
Bayer Identifier:
22752
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2024-517419-62-00
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.
Inclusion Criteria
- 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
Exclusion 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale Bordeaux, France, 33000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sarah Cannon Research Institute (SCRI) - Nashville Nashville, United States, 37203 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Hospital East (NCCHE) - Kashiwa Campus Kashiwa, Japan, 277-8577 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Oscar Lambret - Service Oncologie Lille, France, 59000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Cancer Hospital Beijing, China, 100142 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rigshospitalet - Kræftbehandling Copenhagen, Denmark, 2100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Princess Margaret Cancer Centre – University Health Network - Department of Medical Oncology and Hematology Toronto, Canada, M5G 2C4 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth II Health Sciences Centre - Victoria General Site Halifax, Canada, B3H 1V7 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030-4000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals L'Hospitalet de Llobregat, Spain, 08908 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid Madrid, Spain, 28027 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacion Jimenez Diaz (Clinica de la Concepcion) Madrid, Spain, 28040 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO) Barcelona, Spain, 8035 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations McGill University Health Centre – Glen Site Montreal, Canada, H4A 3J1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus University Hospital Aarhus N, Denmark, 8200 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Odense University Hospital - Oncology Department Odense C, Denmark, 5000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fudan University Shanghai Cancer Center Shanghai, China, 200000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hunan Cancer Hospital Changsha, China, 410013 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, Unmapped, 05505 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, Unmapped, 135-710 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, Unmapped, 3080 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, Unmapped, 03722 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UW Health - UW Carbone Cancer Center - Medical Oncology Clinic Madison, United States, 53792 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City of Hope - Duarte Cancer Center Duarte, United States, 91010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Lyon Sud - Service oncologie médicale Pierre-Benite, France, 69310 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital La Cavale Blanche - CHU de Brest - Service oncologie médicale Brest, France, 29200 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aichi Cancer Center Hospital Nagoya, Japan, 464-8681 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Cancer Institute Hospital of JFCR Koto-ku, Japan, 135-8550 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kindai University Hospital Osakasayama, Japan, 589-8511 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Hospital Chuo-ku, Japan, 104-0045 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale Reggio Emilia, Italy, 42123 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1 Milano, Italy, 20133 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica Roma, Italy, 00168 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongshan Hospital, Fudan University Shanghai, China, 200032 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine Hangzhou, China, 310016 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Macquarie University Hospital Sydney, Australia, 2109 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dana-Farber Cancer Institute Boston, United States, 02215 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University First Hospital Beijing, China, 100034 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univestitätsspital Zürich (USZ) Zürich, Switzerland, 8091 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inselspital Bern - Universitätsklinik für Medizinische Onkologie Bern, Switzerland, 3010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Profound Research LLC Farmington Hills, United States, 48334 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopitaux Universitaires de Geneve Genève, Switzerland, 1205 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ICON Cancer Centre - Southport Southport, Australia, 4215 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Blacktown Cancer & Haematology Centre Blacktown, Australia, 2148 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus Fort Myers, United States, 33908 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cleveland Clinic Cleveland, United States, 44195 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Alabama at Birmingham Birmingham, United States, 35233 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A Phase 2 open-label basket study to evaluate the efficacy and safety of orally administered reversible tyrosine kinase inhibitor BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1
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)Timeframe: 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)Timeframe: 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)Timeframe: 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 1.1Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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 firstTimeframe: 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 1.1Timeframe: 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 1.1Timeframe: 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.Timeframe: 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.Timeframe: 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 30Timeframe: 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 30Timeframe: 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 30Timeframe: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Additional Information
Copyright © Bayer
Powered by
