All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

This research study, called MTAPESTRY 101, is looking into a new treatment named Anvumetostat for adults with advanced solid cancers that have lost a specific gene called MTAP. This gene loss can make cancer cells grow differently. The first parts of the study aim to figure out the safest and most effective dose of Anvumetostat, both by itself and when given with another common cancer drug called Docetaxel. Doctors will carefully watch for any side effects to make sure the treatment is as gentle as possible while still fighting the cancer. Later, the study will focus on how well Anvumetostat shrinks or controls these cancers. If you have advanced cancer and your doctor confirms your tumor is missing the MTAP gene, this study might be an option to consider.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Amgen
Enrolment target
329
Start
01 Feb 2022
Estimated completion
30 Nov 2026

What is this study about?

This study is exploring a new treatment called Anvumetostat for a specific type of advanced cancer. Our bodies have many genes, and some cancers develop when certain genes are missing or not working properly. In this case, the study is focusing on solid tumors (meaning not blood cancers) that have lost a gene called MTAP. This particular genetic change might make cancer cells more sensitive to certain treatments, which is what researchers hope to find out with Anvumetostat.

The study has different stages, or 'parts'. In the early stages, nicknamed Phase 1 and Phase 2, the main goal is to find the best and safest dose of Anvumetostat. This involves giving different amounts of the drug to participants and carefully watching for any side effects to establish what's called a 'maximum tolerated dose' or a 'recommended dose'. Sometimes, Anvumetostat might be given alongside another established cancer drug, Docetaxel, to see if they work better together.

Once the safest dose is found, the study moves into a later stage, where the focus shifts to how well Anvumetostat actually works against the cancer. This means doctors will be looking to see if the treatment shrinks the tumors or stops them from growing in people with advanced MTAP-null solid tumors.

Key takeaways

  • This study is for advanced solid cancers where the MTAP gene is missing.
  • It's testing a new medicine called Anvumetostat, sometimes with Docetaxel.
  • The main goals are to find a safe dose and see how well it works.
  • Participation involves taking tablets and having regular hospital visits for checks.
  • You will be closely monitored for side effects.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 or older. A key requirement is that your advanced solid cancer must be missing a specific gene called MTAP. Your doctor will be able to test your tumor for this. You'll also need to have cancer that can't be cured by standard surgery or radiation alone, and your doctors must be able to measure your cancer to see if the treatment is working.

Beyond your cancer diagnosis, the medical team will check your general health to make sure you're well enough to take part. This includes checking how your heart, lungs, kidneys, and liver are working. You'll also need to be able to swallow pills, as the study drug is taken by mouth, and be willing to keep a record of when you take it.

In some specific parts of the study, you might need to provide a recent tumor sample (either existing tissue or sometimes a new biopsy) for testing. This helps researchers understand more about your cancer and how the treatment might affect it.

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 old or older?
  2. Has your doctor confirmed your advanced cancer is 'MTAP-null' (missing the MTAP gene)?
  3. Can you swallow tablets?
  4. Are you able to visit the hospital regularly for appointments and tests?
  5. Are your major organs (like heart, lungs, kidneys, liver) generally healthy?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll first have a number of health checks and tests to make sure it's suitable for you. Once enrolled, you'll take the study medication, Anvumetostat, likely as tablets you swallow. In some cases, you might also receive the cancer drug Docetaxel, which is given through a drip.

You will have regular hospital visits for check-ups, blood tests, scans, and to discuss any side effects you might be experiencing. These visits help the study team monitor your health and how the treatment is working. The exact number and frequency of visits will depend on which part of the study you are in, but they will be clearly explained to you before you start. You'll also be asked to keep track of when you take your medicine at home. The study will involve ongoing treatment and follow-up for a period that your doctor can explain, continuing as long as the treatment is helping and side effects are manageable.

Potential risks and benefits

Taking part in any medical study carries both potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available, and it could help to control your cancer. However, there's no guarantee it will work for everyone, and it might not be more effective than standard treatments. As with any drug, Anvumetostat could cause side effects, which might be mild or more serious. The study team will carefully monitor you for these. You will be given a full list of possible side effects before you decide to take part. Remember, joining a study is always your choice, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (75)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • City of Hope National Medical Center
    Verified postcode
    Duarte, United States
  • California Research Institute
    Verified postcode
    Glendale, United States
  • Fomat Medical Research
    Verified postcode
    Oxnard, United States
  • University of California at SF
    Verified postcode
    San Francisco, United States
  • D and H Cancer Research Center
    Verified postcode
    Margate, United States
  • Boca Raton Clinical Research Medical Center Inc
    Verified postcode
    Tamarac, United States
  • Goshen Health Systems
    Verified postcode
    Goshen, United States
  • Indiana University
    Verified postcode
    Indianapolis, United States
  • Community Health Network MD Anderson Cancer Center - North
    Verified postcode
    Indianapolis, United States
  • University of Maryland Medical Center
    Verified postcode
    Baltimore, United States
  • American Oncology Partners, PA
    Verified postcode
    Bethesda, United States
  • Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
    Verified postcode
    Detroit, United States

Common questions

What does 'MTAP-null' mean?

It means your cancer cells are missing a specific gene called MTAP. Doctors will test your tumor to see if you have this gene missing.

Is Anvumetostat a pill or an injection?

Anvumetostat is given as tablets that you swallow. Another drug, Docetaxel, if used, is given as an injection into a vein.

How long will I be in the study?

The study involves ongoing treatment and checks. Your doctor will explain the expected duration based on your individual response and tolerability.

What if I experience side effects?

The study team will monitor you closely for side effects, and you should report any new or worsening symptoms immediately so they can be managed.

Can I stop participating if I want to?

Yes, you have the right to leave the study at any time, for any reason, without it affecting your regular medical 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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