- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2025-02-13
2027-02-03
2027-10-25
111
NCT06760819
Bayer
Bayer
INTERVENTIONAL
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) 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)
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 (sevabertinib) 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 breast, 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-12-18 | N/A | 2025-09-04 |
2024-12-30 | N/A | 2025-09-11 |
2025-01-07 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: BAY2927088 Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, breast, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until | DRUG: BAY2927088
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR | 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) | 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 Measures | Measure Description | Time Frame |
|---|---|---|
| Duration of response (DOR) per RECIST 1.1 as assessed by BICR | 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) | 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 BICR | 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) | 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 investigator | 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 1.1 | 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 BICR | 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. | 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 BICR | 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. | 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 BICR | 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. | 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 investigator | 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. | 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 investigator | 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. | 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 investigator | 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 | 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 investigator | 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 1.1 | 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 investigator | 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 1.1 | 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. | 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 AE | From first administration of study intervention up to 30 days after the last dose of study intervention. | 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 score | 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 30 | 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 score | 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 | 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 30 | Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Bayer Clinical Trials Contact Phone Number: (+)1-888-84 22937 Email: clinical-trials-contact@bayer.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
