A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
This study is testing a new treatment called BAY 3713372 for solid tumours where a particular gene, called MTAP, is missing. Scientists believe this drug might work by targeting a specific protein (PRMT5) that helps these particular cancer cells grow, without harming healthy cells. The main goals are to find out if BAY 3713372 is safe, how the body handles it, and how well it helps people with these specific cancers. Researchers will start by giving different doses to small groups to find the safest and most effective amount, then test it on more people. The study will also look at whether the treatment shrinks tumours or stops them from growing.
At a glance
What is this study about?
This research study is investigating a new medication called BAY 3713372 for people who have solid tumours where a specific gene, known as MTAP, is missing. This type of genetic change can sometimes allow cancer cells to grow more easily. Researchers believe that BAY 3713372 might work by blocking a protein called PRMT5, which is important for the survival of these particular cancer cells. The hope is that by blocking PRMT5, the drug could kill the cancer cells while leaving healthy, normal cells unharmed.
The main purpose of this early-stage study is to understand how safe BAY 3713372 is for people, how the body processes it, and whether it shows signs of helping to treat these MTAP-deleted solid tumours. To do this, the study will involve different groups of participants. Initially, small groups will receive varying doses of the treatment to find a safe and effective amount. Once a suitable dose is identified, more participants will receive the treatment, sometimes on its own or occasionally with other standard treatments.
Beyond safety, doctors will also carefully watch to see if the treatment shrinks tumours, stops them from growing, or extends the time people live without their cancer worsening. This is an important step in developing new cancer treatments, aiming to provide more options for patients in the future.
Key takeaways
- Tests new drug (BAY 3713372) for specific cancers.
- Aims to find safe doses and how the drug works.
- Involves regular hospital visits for monitoring.
- Could help future patients with MTAP-deleted solid tumours.
- Your health will be closely supervised throughout the study.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be 18 years old or older. You need to have a solid tumour that has been identified as missing the MTAP gene through specific genetic tests. Your cancer must also have at least one measurable area that doctors can track.
Your general health and daily activity level will also be checked, and you would need to meet certain standards for how well you can perform routine tasks. You also can't have certain other health conditions, especially related to your heart, or a history of specific serious heart problems in the recent past.
You would not be able to join if you have had another cancer in the last two years (unless it was a very common and usually curable type like certain skin cancers, or one your doctor believes is completely cured and won't affect the study). Also, certain irregularities in your heart's electrical activity or specific heart conditions would prevent you from taking part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Has your solid tumour been identified as missing the MTAP gene?
- Do you have at least one measurable area of cancer that doctors can track?
- Do you generally feel well enough to participate in daily activities?
- Do you have any serious heart conditions or recent heart problems?
- Have you had another cancer in the last two years (excluding common, curable types)?
What does participation involve?
If you decide to take part, you'll visit the study site at least twice before starting treatment. Once treatment begins, you'll attend several appointments. You will receive the study medication, BAY 3713372, and can continue taking it as long as it's helping you and you don't experience severe side effects. About 30 days after your last dose, you'll have a follow-up visit, and then you'll continue to have check-ups every 9 weeks until your cancer worsens or you stop the treatment for another reason.
During your visits, the study team will closely monitor your health. This includes regular blood and urine tests, and heart checks using an electrocardiogram (ECG). They will also use CT or MRI scans, and sometimes bone scans, to see how your cancer is responding and if it has grown or spread. Tumour samples might also be taken.
Even after you stop taking the treatment, the study doctors and their team will keep in touch every three months for up to two years to understand how you are doing.
Potential risks and benefits
Locations (60)
- UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB HospitalVerified postcodeBirmingham, United States· Not yet recruiting
- City of Hope - Duarte Cancer CenterVerified postcodeDuarte, United States· Not yet recruiting
- UCLA Health Bowyer Oncology CenterVerified postcodeLos Angeles, United States· Not yet recruiting
- UCSF Helen Diller Medical Center at Parnassus Heights - NeurologyVerified postcodeSan Francisco, United States· Not yet recruiting
- Stanford University Medical Center - NeurologyVerified postcodeStanford, United States· Not yet recruiting
- UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer CenterVerified postcodeAurora, United States· Not yet recruiting
- Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke'sVerified postcodeDenver, United States· Recruiting
- Sarah Cannon Research Institute at Florida Cancer Specialists- Lake NonaVerified postcodeOrlando, United States· Recruiting
- Massachusetts General Hospital - NeurologyVerified postcodeBoston, United States· Not yet recruiting
- Dana-Farber Cancer Institute - Oncology DepartmentVerified postcodeBoston, United States· Not yet recruiting
- START | MidwestVerified postcodeGrand Rapids, United States· Recruiting
- Icahn School of Medicine at Mount Sinai - OncologyVerified postcodeNew York, United States· Not yet recruiting
Common questions
What is an MTAP-deleted solid tumour?
It's a type of cancer that has a specific gene called MTAP missing. This genetic change might make certain cancer cells grow more easily.
What is BAY 3713372?
It's a new, experimental drug being tested to treat MTAP-deleted solid tumours. It aims to block a protein important for these cancer cells.
What will happen during the study visits?
Doctors will check your health with blood and urine tests, heart checks, and scans like CT or MRI to see how your cancer is doing.
Why is this study important?
This study helps researchers learn if this new drug is safe and effective, which could lead to new treatment options for people with MTAP-deleted solid tumours.
Can I stop participating in the study at any time?
Yes, you can choose to leave the study at any point, and it won't affect your future medical care.
How to find out more
Bayer Clinical Trials Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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