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Active not recruitingPHASE1INTERVENTIONAL

A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors

This research study is testing a new drug called ALTA2618 for adults living with certain types of advanced cancer, including breast cancer, that have a specific genetic change in their tumour, known as the AKT1 E17K mutation. The main aim is to understand how safe the medicine is, what side effects it might cause, and to find the best dose. ALTA2618 works by targeting this particular genetic change. The study involves two parts: a first stage to carefully increase doses to find a safe level, and a second stage to further explore that dose. This is a "Phase 1" study, which means it's one of the first times this medicine is being tested in people.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Alterome Therapeutics, Inc.
Enrolment target
110
Start
22 Aug 2024
Estimated completion
29 Dec 2027

What is this study about?

This study is exploring a new medicine called ALTA2618. It's designed for adults who have a type of cancer that has spread or can't be removed with surgery, and importantly, their cancer cells have a specific genetic change (mutation) called 'AKT1 E17K'. This mutation can sometimes make cancer grow, and ALTA2618 is designed to specifically target it. This is an early-stage study, known as 'Phase 1', which means researchers are mainly focused on making sure the drug is safe and finding the best dose. They will also be looking to see if the medicine has any positive effects on the cancer.

Over two parts, the study will involve different groups of patients. In the first part, called 'Dose Escalation', patients will receive increasing doses of ALTA2618 under careful medical supervision to find out what dose is safe and well-tolerated. Once a safe dose is identified, the second part, 'Dose Expansion', will involve more patients receiving that dose to gather more information about its safety and how it affects the cancer.

This is an "open-label" study, meaning both you and your study doctor will know you are receiving ALTA2618. The information gathered from this study will help doctors learn more about this new treatment and potentially move it forward to bigger studies in the future, with the hope of developing new ways to treat these specific cancers.

Key takeaways

  • This study is for adults with advanced cancers that have a specific genetic change called AKT1 E17K.
  • It's testing a new medicine, ALTA2618, which is designed to target this genetic change.
  • The main goals are to check the medicine's safety, understand any side effects, and find the right dose.
  • This is an early-stage (Phase 1) study.
  • Participants will take the medicine as a tablet and have regular checks and tests.
  • You can stop participating at any time if you wish.

Who may be eligible?

To join this study, adults must be at least 18 years old and have a solid tumour cancer (like breast cancer or other types) that has been medically confirmed to have the 'AKT1 E17K' genetic change. This genetic change would have been found through specific tests. Your cancer would also need to be advanced, meaning it's spread or can't be removed, and you would have already tried standard treatments that didn't work, couldn't be tolerated, or you chose not to have them.

There are also some health requirements, such as being generally well enough to take part and having important organs (like your liver and kidneys) working properly. Doctors will also need to be able to measure or assess your cancer to see how it responds to the treatment.

However, some things would prevent you from joining. For example, if you've already had certain drugs that work in a similar way (PI3K or mTOR inhibitors) or if your cancer has different specific genetic changes (like KRAS, NRAS, HRAS, or BRAF). You also wouldn't be able to join if you have a condition making it hard to swallow or absorb oral medication, as ALTA2618 is a tablet. Your study doctor will review all criteria to see if this study is right 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.

  1. Are you 18 years old or over?
  2. Has your cancer been tested and confirmed to have the 'AKT1 E17K' genetic change?
  3. Is your cancer advanced (spread or cannot be removed by surgery)?
  4. Have standard treatments for your cancer not worked, or were they unsuitable for you?
  5. Are you generally well enough to take part and have important organs (like liver/kidneys) working correctly?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, ALTA2618, as a tablet. You would have regular visits to the study clinic for check-ups, blood tests, and scans to monitor your health and how the medicine is affecting your cancer. These tests will help doctors understand how your body handles the medicine and if it's having any effect on your tumour. The visits would be more frequent at the beginning of the study, especially during the dose-finding part, and might become less frequent later on. The total length of your participation would depend on how your cancer responds and how you tolerate the treatment, but you would be followed up regularly. Your study team would explain the exact schedule in detail.

Potential risks and benefits

Participating in a study like this might offer a potential benefit if ALTA2618 helps to control your cancer, especially if other treatments haven't worked or aren't suitable. However, as with any new medicine, there are risks, and you might experience side effects that are not yet fully known. The study team will carefully monitor you for any side effects and manage them as best as possible. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (46)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    La Jolla, United States
  • Research Site
    Verified postcode
    Denver, United States
  • Research Site
    Verified postcode
    Sarasota, United States
  • Research Site
    Verified postcode
    Atlanta, United States
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    St Louis, United States
  • Research Site
    Verified postcode
    Maumee, United States
  • Research Site
    Verified postcode
    Nashville, United States
  • Research Site
    Verified postcode
    Houston, United States
  • Research Site #2
    Verified postcode
    San Antonio, United States
  • Research Site
    Verified postcode
    San Antonio, United States

Common questions

What is an 'AKT1 E17K mutation'?

It's a specific change in the DNA of your cancer cells that can sometimes make the cancer grow. This study is testing a drug that targets this particular change.

What does 'Phase 1' mean for a study?

Phase 1 means it's an early step in testing a new medicine in people. The main goals are to check its safety, understand any side effects, and find the right dose. It's not primarily focused on whether it cures cancer at this stage.

Will I know if I'm getting the actual drug?

Yes, this is an "open-label" study, which means both you and your study doctor will know you are receiving ALTA2618.

Can I stop participating in the study if I want to?

Absolutely. You can choose to leave the study at any time, for any reason, and this will not affect your ongoing medical care.

What are 'solid tumours'?

Solid tumours are abnormal growths of tissue that usually form a lump, unlike blood cancers. Examples include breast cancer, bowel cancer, and lung cancer.

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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