A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors
This research is looking for new ways to treat advanced solid tumors, which are cancers that might have spread and are hard to treat with current methods. The study is focusing on specific types of skin, kidney, stomach, and lung cancer. The new drug, BAY2965501, is being tested to see how safe it is, the best dose to use, and how it moves through the body. It works by making the body's immune cells (called T-cells) more active to fight cancer. Researchers also want to see if it makes tumors smaller. This is a 'first-in-human' study, meaning it's one of the first times this drug is being given to people. It will be given by itself or with other cancer treatments like pembrolizumab and chemotherapy. The goal is to find a safe and effective treatment for people with these advanced cancers.
At a glance
What is this study about?
This study is exploring a new treatment called BAY2965501 for people with advanced solid tumors. Advanced solid tumors are cancers that have grown or spread and are not easily treated with what’s currently available. This includes certain types of skin cancer, kidney cancer, stomach cancer, and lung cancer. The main goal is to find a better way to help people with these challenging cancers.
The new drug, BAY2965501, works by targeting your body's immune system. Specifically, it 'wakes up' certain immune cells, called T-cells, which are known to fight cancer. By activating these T-cells, the hope is that your own body can do a better job of attacking the cancer. This is a type of treatment called immunotherapy. Researchers want to understand how safe BAY2965501 is, what the best amount (dose) to give is, and whether it can help shrink tumors when given alone or with other cancer medicines.
Because this is a very early study (called 'first-in-human' or Phase 1), the first steps are to carefully check for side effects and find the highest dose that people can safely take. They will also look at how the drug travels through your body. Later, once a safe dose is found, they will look more closely at how the drug affects the tumors. The study involves two main parts: first, finding the right dose, and then, expanding to understand its effects more broadly.
Key takeaways
- This study tests a new cancer drug (BAY2965501) for advanced solid tumors, including certain skin, kidney, stomach, and lung cancers.
- The drug aims to boost your own immune system to fight cancer.
- It's a Phase 1 study, focusing on finding a safe dose and understanding side effects.
- You might receive the new drug alone or with other cancer medicines.
- Regular health checks and scans will be done to monitor your health and tumor changes.
- You can stop participating at any time.
Who may be eligible?
To join this study, you generally need to be an adult (18 or older) with an advanced solid tumor. This means your cancer may have spread and is not responding well to standard treatments. Your overall health and ability to carry out daily activities will be assessed (doctors call this your 'performance status').
For the first part of the study (finding the right dose), most types of solid cancers are included. For the second part (looking at treatment effects), specific types like non-small cell lung cancer, stomach cancer, and some others are being highlighted. If you are joining a group where BAY2965501 is combined with chemotherapy, your cancer needs to be a type that usually responds to platinum-based chemotherapy.
You cannot join this study if you have previously taken a similar type of drug that blocks a specific enzyme (DGK inhibitor), other than a very closely related study drug. The study team will review all your medical information carefully to make sure the study is suitable and safe for you.
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?
- Do you have an advanced solid tumor that current treatments aren't controlling well?
- Do you feel well enough to carry out most of your daily activities?
- Have you *not* had a similar type of DGK inhibitor drug before (other than BAY 2862789)?
- For certain groups, is your specific cancer type (e.g., NSCLC, gastric cancer) listed for the second part of the study?
- If platinum-based chemotherapy is part of the combination, is your cancer type usually treated with platinum-based drugs?
What does participation involve?
If you decide to take part, the study will involve several stages. First, there's a screening phase of up to 28 days to check if the study is right for you. If you qualify, you'll start the treatment phase.
You will take BAY2965501 by mouth, as a tablet. Depending on which group you are in, you might also receive other medicines: pembrolizumab, which is given through a drip into your vein, and/or platinum-based chemotherapy, also given through a drip.
The study involves regular visits where the team will take blood and urine samples, do physical checks, measure your blood pressure, heart rate, and temperature, and check your heart with an ECG. They will also use scans like CT or MRI to see if your cancer has changed, and sometimes take small tumor samples. You will continue treatment for several months, potentially up to 35 treatment cycles, until your cancer starts to get worse or if you experience significant side effects. After treatment, there will be a follow-up period to monitor your health and cancer changes, which will happen every few months.
Potential risks and benefits
Locations (21)
- Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke'sVerified postcodeDenver, United States
- UPMC Hillman Cancer CenterVerified postcodePittsburgh, United States
- START | San AntonioVerified postcodeSan Antonio, United States
- Antwerp University Hospital | Oncology DepartmentVerified postcodeAntwerp, Belgium
- Ghent University Hospital | Drug Research Unit DepartmentVerified postcodeGhent, Belgium
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology DepartmentVerified postcodeHangzhou, China
- Cancer Hospital, Chinese Academy of Medical SciencesVerified postcodeBeijing, China
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen CenterVerified postcodeShenzhen, China
- National Cancer Center Hospital EastVerified postcodeKashiwa, Japan
- Seoul National University Bundang HospitalVerified postcodeSeongnam-si, South Korea
- Severance Hospital, Yonsei University Health System - Oncology DepartmentVerified postcodeSeoul, South Korea
- Samsung Medical Center - Oncology DepartmentVerified postcodeSeoul, South Korea
Common questions
What does 'first-in-human' mean?
It means this is one of the first times this new drug is being given to people, so doctors are learning a lot about it for the first time.
What are 'advanced solid tumors'?
These are cancers that have grown or spread to other parts of the body and are proving difficult to treat with existing medicines.
How does BAY2965501 work?
It's designed to 'wake up' your body's immune cells (T-cells) so they can become more active in fighting your cancer.
Will I get the new drug only, or other treatments too?
You might get BAY2965501 on its own, or in combination with other established cancer treatments like pembrolizumab and/or chemotherapy, depending on your study group.
How long will the study treatment last?
You could be on the study treatment for several months, potentially up to 35 treatment cycles, as long as your cancer doesn't get worse and side effects are manageable.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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