Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
The MTAPESTRY 104 study is looking into a new treatment called Anvumetostat for adults with advanced lung cancers that have a specific genetic change, known as a homozygous MTAP-deletion. This study is in its early stages (Phase 1) and aims to discover the highest safe dose of Anvumetostat when given by itself or alongside other existing cancer drugs like Carboplatin, Paclitaxel, Pembrolizumab, Pemetrexed, or Sotorasib. Researchers also want to understand the side effects and overall safety of these combinations. The goal is to provide new treatment options for patients whose cancers have this particular genetic marker.
At a glance
What is this study about?
This study, known as MTAPESTRY 104, is exploring new ways to treat certain types of advanced lung cancer. Specifically, it's for people whose cancers have a particular genetic change called a homozygous MTAP-deletion. This deletion means that a specific gene is missing from both copies in your cancer cells, which can make your cancer respond differently to treatments. Researchers are interested in a new drug called Anvumetostat, which works by targeting a pathway affected by this gene change. The hope is that Anvumetostat, either on its own or teamed up with other established cancer treatments, could offer a new and effective option for these specific lung cancers.
The main goal of this early-stage study (Phase 1) is to figure out the right amount of Anvumetostat to give to patients. This involves carefully increasing the dose to find the highest amount that patients can take without experiencing too many severe side effects. This is known as the 'maximum tolerated dose.' They are also looking to see what side effects people might experience with these new drug combinations.
By carefully studying Anvumetostat in combination with other common lung cancer medicines, doctors hope to learn how to best use it in the future. This research is important because it could lead to new avenues of treatment for people with these specific genetic changes in their thoracic (chest) tumors, ultimately aiming to improve patient outcomes.
Key takeaways
- This study is for advanced lung cancers with a specific genetic change (MTAP-deletion).
- It's testing a new drug, Anvumetostat, alone or with other cancer treatments.
- The main goal is to find the safest and most effective dose of the treatment combinations.
- This is an early-stage (Phase 1) study.
- Participation involves regular clinic visits for monitoring and assessments.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you generally need to be at least 18 years old and have advanced lung cancer that doctors have confirmed has a specific genetic change called a 'homozygous MTAP-deletion.' Your cancer must also be measurable, meaning doctors can track its size. You should also be able to swallow medicines by mouth without difficulty, and doctors will need a sample of your tumor tissue to confirm your diagnosis.
There are different groups within the study based on your specific type of lung cancer. For example, some groups are for non-small cell lung cancer (NSCLC) that is predominantly squamous or non-squamous, or NSCLC with a particular KRAS gene change, or even NSCLC that has spread to the brain. Your doctor will help determine if you fit into one of these specific groups.
However, some things would prevent you from joining. These include certain heart or lung problems, severe digestive issues that stop you from taking oral medicine, having had an organ transplant, recent major surgery or radiation treatment (within the last 28 days), or if you've previously taken similar types of drugs to Anvumetostat. If you have autoimmune diseases, that would also prevent you from joining some parts of the study.
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 or older?
- Do you have advanced lung cancer with a confirmed MTAP-deletion?
- Can you swallow oral medication easily?
- Have you avoided major surgery or radiation in the last 28 days?
- Have you not received similar experimental treatments before?
What does participation involve?
If you decide to participate in the MTAPESTRY 104 study, you will be given Anvumetostat, either alone or combined with other cancer medications like Carboplatin, Paclitaxel, Pembrolizumab, Pemetrexed, or Sotorasib. The specific combination will depend on your cancer type and what group you're in. These medications might be given as pills you swallow, or through an IV (into a vein).
Throughout the study, you'll have regular visits to the clinic for various assessments. These will include physical exams, blood tests, and scans (like CT scans) to check how the treatment affects your cancer and your overall health. The frequency of these visits and tests will be explained to you in detail by the study team. They will also closely monitor you for any side effects. You will continue to receive treatment for as long as it benefits you and you tolerate it well. The total duration someone participates varies, but there will be ongoing follow-up visits even after treatment stops to monitor your health.
Potential risks and benefits
Locations (83)
- Comprehensive Blood and Cancer CenterVerified postcodeBakersfield, United States
- City of Hope National Medical CenterVerified postcodeDuarte, United States
- City of Hope Orange County Lennar Foundation Cancer CenterVerified postcodeDuarte, United States
- Translational Research in Oncology US Inc, Trio Central PharmacyVerified postcodeLos Angeles, United States
- University of California IrvineVerified postcodeOrange, United States
- University of California Los AngelesVerified postcodeSanta Monica, United States
- Rocky Mountain Cancer CentersVerified postcodeDenver, United States
- Eastern Connecticut Hematology and Oncology AssociatesVerified postcodeNorwich, United States
- HealthPartners InstituteVerified postcodeSaint Paul, United States
- Saint Lukes Hospital of Kansas CityVerified postcodeKansas City, United States
- Comprehensive Cancer Centers of NevadaVerified postcodeLas Vegas, United States
- Roswell Park Cancer InstituteVerified postcodeBuffalo, United States
Common questions
What is a homozygous MTAP-deletion?
It means a specific gene is missing from both copies within your cancer cells. This specific genetic change might make certain treatments work differently.
What does 'Phase 1' mean for a drug study?
Phase 1 is the earliest stage of human testing. It's mainly about finding a safe dose and understanding initial side effects of a new drug, rather than proving it cures cancer.
Will I know if I'm getting the new drug or a standard treatment?
In this study, everyone receives Anvumetostat, either alone or with other active cancer drugs. There is no placebo group.
What kind of tests will I have during the study?
You'll have regular physical exams, blood tests, and scans (like CT scans) to check your health and how the treatment is working.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any point and for any reason, and this decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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