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 trialsresearch studies performed to test new treatments, tests or procedures and evaluate their effectiveness on various diseases 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 colonthe longest portion of the large bowel that absorbs water and salts from ingested food or rectumthe last section of the large intestine/bowel that holds waste until it is ready to be removed from the body, the uterus and the cervix (lower part of the uterus), the bladdera hollow, muscular sac in the pelvis that stores urine, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advancedat a late stage, far along non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (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 cellsthe basic structural and functional unit of all living things, 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 imagingtests that create detailed images of areas inside the body scans of different parts of the body to study the spread of cancer and will check heart health using echocardiograma type of ultrasound that uses sound waves to create detailed images of the heart to assess heart structure, function and blood flow or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take bloodthe red bodily fluid that transports oxygen and other nutrients around the body 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.
Intervention / Treatment
- Drug: BAY2927088
Inclusion Criteria:
- Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectalrelating to the colon or rectum in the large bowel/intestine carcinomacancer arising from tissues that line organs; 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