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Active not recruitingPHASE1INTERVENTIONAL

A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)

This study, called MTAPESTRY 103, is trying out new drug combinations for people with advanced stomach, bile duct, or pancreatic cancers. Researchers are specifically looking for cancers that have a genetic change called a 'MTAP-deletion'. The main goals are to find the highest safe dose of a new drug called Anvumetostat when given with other standard treatments, and to understand any side effects. This is an early-stage study (Phase 1), which means it's one of the first times these drug combinations are being tested in people. It aims to see if the new treatments are safe enough to be studied further.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Amgen
Enrolment target
120
Start
29 May 2024
Estimated completion
30 Nov 2026

What is this study about?

This research is looking for better ways to treat advanced stomach, bile duct, and pancreatic cancers. These are cancers that have spread or are difficult to remove with surgery. The study is particularly interested in cancers that have a specific genetic change, which doctors call a 'MTAP-deletion.' This deletion means a certain gene is missing, and scientists believe this missing gene might make the cancer more responsive to particular types of drugs.

The main drug being tested is Anvumetostat. This drug is designed to target certain processes within cancer cells. In this study, Anvumetostat will be given alongside other well-known cancer treatments that patients might already be familiar with, such as Gemcitabine, Nab-paclitaxel, or Modified FOLFIRINOX. Researchers want to see how these combinations work together.

This is a Phase 1 study, which is the earliest stage of human testing for new treatments. The primary goals are to find the right dose of Anvumetostat when combined with other drugs – one that is strong enough to potentially fight the cancer but also safe and manageable for patients. They will also be carefully monitoring for any side effects to understand how safe these new treatment combinations are.

Key takeaways

  • This study is testing new drug combinations for advanced stomach, bile duct, or pancreatic cancers.
  • It's for cancers with a specific genetic change called 'MTAP-deletion'.
  • The main goals are to find safe doses and understand side effects.
  • It's an early-stage (Phase 1) study.
  • You'll receive Anvumetostat plus other standard cancer treatments.
  • Participation involves regular check-ups and monitoring.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and have been diagnosed with advanced stomach, bile duct, or pancreatic cancer that has a specific genetic change called a 'MTAP-deletion'. Your doctor would need to confirm this from a sample of your cancer tissue. Your cancer also needs to be measurable, meaning doctors can track its size.

There are some reasons why you might not be able to join. For example, if you've recently had certain types of cancer treatment like radiation or major surgery within the last month. You also can't have received similar new types of drugs (MAT2A or PRMT5 inhibitors) in the past. If you have severe heart, lung, or digestive problems that would make it difficult to take medicines or keep you safe, you might not be eligible.

For one part of the study (Subprotocol C), if you have advanced pancreatic cancer with the MTAP-deletion and another specific genetic change called a 'RAS mutation', and have already had at least one other treatment for your cancer, you might be able to join. However, if you've previously been treated with certain drugs that target the 'MAPK pathway' or 'KRAS inhibitors', you would not be able to participate in this part 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.

  1. Are you 18 years or older?
  2. Do you have advanced stomach, bile duct, or pancreatic cancer?
  3. Has your doctor confirmed your cancer has an 'MTAP-deletion'?
  4. Have you recently had specific targeted cancer drugs (MAT2A or PRMT5 inhibitors)? (If yes, you may not be eligible)
  5. Are your heart, lung, and digestive systems generally healthy enough for treatment?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication (Anvumetostat) along with other standard cancer treatments. You would have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. Doctors would also carefully look for any side effects. You would continue treatment for as long as it is helping you and you are tolerating it well, or until the study doctor decides it’s best to stop. The exact number of visits and tests would be explained to you by the study team.

Potential risks and benefits

Taking part in this study may offer a potential benefit of receiving a new experimental treatment that might help your cancer, especially if standard treatments haven't been as effective. However, new treatments also come with potential risks, including side effects that are not yet fully known. The research team will monitor you closely for any unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (77)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Comprehensive Blood and Cancer Center
    Verified postcode
    Bakersfield, United States
  • City of Hope National Medical Center
    Verified postcode
    Duarte, United States
  • City of Hope Orange County Lennar Foundation Cancer Center
    Verified postcode
    Duarte, United States
  • University of California San Diego Moores Cancer Center
    Verified postcode
    La Jolla, United States
  • Translational Research in Oncology US Inc, Trio Central Pharmacy
    Verified postcode
    Los Angeles, United States
  • University of California Los Angeles
    Verified postcode
    Santa Monica, United States
  • Rocky Mountain Cancer Centers
    Verified postcode
    Aurora, United States
  • Hartford Hospital
    Verified postcode
    Hartford, United States
  • Yale University
    Verified postcode
    New Haven, United States
  • Norwalk Hospital
    Verified postcode
    Norwalk, United States
  • University of Chicago
    Verified postcode
    Chicago, United States
  • Indiana University
    Verified postcode
    Indianapolis, United States

Common questions

What is a 'MTAP-deletion'?

It's when a specific piece of genetic material (a gene) is missing from your cancer cells. Doctors believe this might make the cancer respond differently to certain treatments.

What does 'Phase 1 study' mean?

It means this is one of the first times this new drug combination is being tested in people. The main goals are to find a safe dose and look for any side effects.

Will I still get my usual cancer treatments?

Yes, Anvumetostat will be given in combination with other standard cancer treatments you might already be familiar with.

What kind of cancers are being studied?

This study is focused on advanced stomach, bile duct (liver area), and pancreatic cancers that have spread or are difficult to remove.

Can I stop participating if I want to?

Yes, you can absolutely decide to leave the study at any time, for any reason, and it will not affect your care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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