AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study to Evaluate the Safety and Tolerability of ARV-806 in Adults with Advanced Cancer that has the KRAS G12D Mutation

This research study is looking at a new medicine called ARV-806 for adults who have advanced cancer. The cancer needs to have a particular genetic change, known as the KRAS G12D mutation. This is a very early-stage study, called a Phase I trial, which means it's the first time this medicine is being given to people. The main goal is to find out if ARV-806 is safe for people to take and what side effects it might cause. Researchers will also be looking at how well the body handles the medicine. This information is crucial for deciding if the medicine should be tested further in larger studies.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Arvinas Operations Inc.

Enrolment target

Start

12 Mar 2026

KRAS G12D Mutated Advanced Solid Tumors

What is this study about?

This clinical trial is about a new possible medicine, ARV-806, for adults who have advanced cancer. 'Advanced cancer' means the cancer has spread from where it started. This study is specifically for people whose cancer has a particular change (called a mutation) in a gene known as KRAS G12D. This mutation can make cancer grow and spread.

Because this is a very early study, called a Phase I trial, it's the first time ARV-806 is being given to people. The main purpose is to carefully check if the medicine is safe and to understand any side effects people might have. Researchers will also learn how the body processes the medicine. This helps them find the right dose and decide if the medicine has potential.

Finding new ways to treat cancer, especially for specific types like those with the KRAS G12D mutation, is an important area of research. By taking part in studies like this, volunteers help doctors learn more about diseases and develop better treatments for the future.

Key takeaways

This study is for adults with advanced cancer that has a specific KRAS G12D gene change.
It's a very early-stage trial (Phase I) to check how safe a new medicine (ARV-806) is and what side effects it might have.
Participants will receive the new medicine and have regular health checks.
There are potential benefits and risks, and your safety will be closely monitored.
Your participation is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, you must be 18 years old or older. The good news is that both men and women can take part.

A very important condition is that your cancer must have a specific genetic change called the KRAS G12D mutation. Your doctor would have already done tests to identify this. Your cancer should also be advanced, meaning it has spread beyond its original site.

There will be other detailed health checks to make sure taking part is safe for you. Your current health, other medicines you're taking, and previous treatments will all be considered.

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 old or older?
Has your doctor told you that you have advanced cancer?
Have tests shown that your cancer has the KRAS G12D gene mutation?
Are you able to attend regular hospital/clinic appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, ARV-806. Because this is a very early study, you would have regular visits to the hospital or clinic. These visits are important so the study team can closely monitor your health, check for any side effects, and see how your body is responding to the medicine. You would likely have blood tests, physical exams, and other assessments. The total time you spend in the study, including follow-up appointments after you stop taking the medicine, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any new medicine study carries both potential risks and benefits. A potential benefit is that ARV-806 might help control your cancer, although this is not guaranteed, especially in early-stage trials. Your health will be very closely monitored by experienced doctors and nurses. However, there's also a chance of experiencing side effects from the new medicine, some of which might be serious or unknown at this time. You will be given all the known information about these risks before you decide to join. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical 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
Italy

Common questions

What does 'KRAS G12D mutation' mean?

It's a specific change in one of your genes inside the cancer cells. This change can make the cancer grow and spread, and this study is looking for a medicine that targets this specific change.

What does 'advanced solid tumours' mean?

It means the cancer started in a solid organ (not in the blood), and it has spread from where it began to other parts of the body.

What is a 'Phase I' study?

This is the very first time this new medicine is being given to people. The main goal is to check if it's safe and to find the right dose.

Will I definitely get the new medicine?

Yes, in this type of Phase I study, everyone who participates and qualifies will receive the new medicine, ARV-806. There isn't a placebo group in this early phase.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason. Your decision will not affect your future medical care.