Brief Summary
The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs cellsthe basic structural and functional unit of all living things while sparing the normal cells.
The main objective of this first-in-human study is to check if BAY 3713372 is safe for further testing and find the dosethe amount of medication taken that could be used to treat different cancer types that are also MTAP-deleted in future studies.
For this, the researchers will study and analyze:
- the number of participants who have adverse events after receiving different doses of BAY 3713372 and their severity.
- the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, their severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose.
- the total amount of BAY 3713372 in participants’ bloodthe red bodily fluid that transports oxygen and other nutrients around the body (also called AUC) over time after single and multiple doses.
- the highest level of BAY 3713372 in participants’ blood (also called Cmax) after single and multiple doses.
Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse.
The study participants will receive BAY 3713372 (starting from low to high doses) in the study, to find the highest safe dose for further testing.
Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems.
Participants will visit the study site:
- at least twice before the treatment starts
- multiple times when they start taking the treatment
- once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason
During the study, the doctors and their study team will:
- check participants’ health by performing tests such as blood and urine teststesting done to measure the levels of certain substances in the urine, and checking heart health using an electrocardiogram
- check if the participants’ cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imagingtests that create detailed images of areas inside the body (MRI) and, if needed, bone scana type of medical imaging that uses a radioactive tracer to detect bone conditions or abnormalities
- take tumor samples
The study doctors and their team will contact the participants every 3 months until 2 years after the last participant’s last dose or the end of the study to learn about the participant’s health.
Intervention / Treatment
- Drug: BAY3713372
Inclusion Criteria:
- Participant age >= 18 years old with solid tumor and at least 1 evaluable lesion as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
- Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1.
- Participants must have exhausted available standard of care treatments known to be beneficial for this tumor type or for whom these treatments are not acceptable and for whom this trial is a reasonable option