Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation

This research study, called AKTive-001, is looking at a new drug named ALTA2618. It's designed for people who have advanced solid tumors – meaning cancers that have spread or are in later stages – and have a specific genetic change in their cancer cells called an AKT1 E17K mutation. This is a very early stage trial, often called a Phase 1 study. Its main goal is to find out if ALTA2618 is safe for people to take, what the right dose might be, and how it affects the body. Researchers also want to see if it shows any signs of helping to treat these cancers. This trial is open to adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Alterome Therapeutics Inc.

Enrolment target

Start

17 Feb 2025

Advanced Solid Tumors with AKT1 E17K Mutation

What is this study about?

This study, named AKTive-001, is a clinical trial focused on a new medicine called ALTA2618. It's designed for people with advanced solid tumors. Advanced solid tumors simply means cancers that have grown or spread beyond their original spot, and often include various types of cancer like bowel, lung, or breast cancer, among others.

The key thing about this study is that it's specifically for people whose cancer has a particular genetic 'fault' or change. This change is called an AKT1 E17K mutation. Think of it like a specific switch in the cancer cells that has gone wrong and helps the cancer grow. The new medicine, ALTA2618, is designed to target this specific faulty switch. Researchers believe that by targeting this particular mutation, they might be able to slow down or even stop the cancer from growing.

Because this is an early-stage (Phase 1) trial, it's the first time this medicine is being given to people. The main goals are to make sure the medicine is safe, to understand any side effects it might cause, and to figure out what dose works best. They will also be looking to see if there are any early signs that the medicine is helping to treat the cancer. These early studies are very important to help develop new and better treatments for specific types of cancer in the future.

Key takeaways

This is an early-stage study testing a new cancer medicine.
It's for specific advanced solid cancers with an 'AKT1 E17K mutation'.
The main goals are to check safety and find the right dose.
There's a chance to access a new treatment, but also unknown risks.
Your cancer must have a specific genetic change to qualify.

Who may be eligible?

To join this study, you would need to meet certain requirements. The most important is that you have a type of cancer called an 'advanced solid tumor.' This means your cancer has spread or is considered to be in a later stage, and it started in a solid organ rather than the blood, for example.

Crucially, your cancer also needs to have a very specific change in its cells called an 'AKT1 E17K mutation.' This mutation is usually identified through special tests on your cancer tissue. If your cancer doesn't have this particular change, you unfortunately wouldn't be able to join this study.

Beyond that, you must be at least 18 years old. Both men and women are welcome to participate. There will be other health checks to make sure you are well enough to take part safely, as is standard for all clinical trials.

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.

I am 18 years old or older.
I have been diagnosed with an advanced solid tumor.
My doctors have confirmed that my cancer has the 'AKT1 E17K mutation'.
I am generally well enough to take part in a study (your doctor will check this).

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups and to receive the study medication. You would likely take the new medicine, ALTA2618, possibly as a pill or infusion. Doctors and nurses would monitor you closely to see how your body reacts to the medicine, looking for any side effects and how well it is working. This would include blood tests, scans, and other assessments. The total time you spend in the study would depend on how your body responds to the treatment. There would also be a follow-up period after you stop taking the study medicine to continue monitoring your health and the effects of the treatment.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as receiving a new and experimental treatment that is not yet widely available for your condition. This investigational medicine might help to control your cancer, although there's no guarantee it will be effective for everyone. On the other hand, there are potential risks, as new medicines can cause side effects that are not fully known yet, ranging from mild to severe. Doctors and nurses will monitor you very closely for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
France

Common questions

What is an 'advanced solid tumor'?

It means your cancer started in a solid organ (like the breast or lung) and has either grown larger, spread to other parts of your body, or is in a later stage.

What is an 'AKT1 E17K mutation'?

It's a specific genetic change or 'fault' found in some cancer cells. This study is testing a medicine designed to target only cancers with this particular change.

Is this medicine available outside the trial?

No, ALTA2618 is an investigational drug, meaning it's still being tested and is not yet available to the general public or prescribed by doctors outside of this study.