AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

This is an early-stage research study looking into a new medicine called VS-7375. It's for people with advanced solid cancers that have a particular gene mutation, or change, known as KRAS G12D. The main goals are to find out if VS-7375 is safe to use and how well people tolerate it. Researchers are also trying to understand how effective it is at shrinking tumors, both when given by itself and when combined with other existing cancer treatments like chemotherapy and immunotherapy. The study involves two phases. The first phase focuses on safety and finding the right dose, while the second phase looks more closely at how well the treatment works. Participants will be carefully monitored for any side effects and their tumor's response to the treatment will be tracked.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Verastem Inc.

Enrolment target

120

Start

09 Jun 2026

Advanced KRAS G12D-Mutant Solid Tumors

What is this study about?

This research study is about a new drug called VS-7375, designed to treat advanced solid cancers that have a specific genetic change, known as a KRAS G12D mutation. This type of gene change can sometimes make cancer cells grow and spread more aggressively. Researchers hope this new drug can specifically target and block this process.

In this study, the new drug VS-7375 is being tested in two ways: first, on its own (as a 'monotherapy'), and second, in combination with other established cancer treatments. The aim is to see if combining VS-7375 with existing treatments could lead to better results for patients. The study has two main parts: an earlier 'Phase 1' that focuses on making sure the drug is safe and finding the best dose, and a 'Phase 2' that looks more at how well the treatment shrinks tumors and helps patients.

The main things the researchers will be watching are any side effects people might experience, how their bodies handle the drug, and how much their tumors respond to the treatment. They will also look at how the new drug interacts with other medicines that are given at the same time. This type of study is crucial for developing new cancer therapies and understanding if they could be helpful for patients in the future.

Key takeaways

Tests a new drug (VS-7375) for advanced solid cancers.
Specifically targets cancers with a KRAS G12D gene change.
Investigates the drug alone and with other cancer treatments.
Focuses on safety, side effects, and tumor shrinkage.
An early-stage study to see if the treatment can help patients.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you must be an adult aged 18 or older. Both men and women are welcome to participate. The most important requirement is that you have an advanced solid cancer that has a specific genetic change in your cancer cells called a KRAS G12D mutation. Your doctor would likely have tested for this.

Since this is a study for advanced cancers, it means your cancer has spread or is difficult to treat with standard therapies. The research team will review your medical history and specific cancer details to determine if this study is suitable for you. They will check to make sure the treatment is as safe as possible given your overall health and other medical conditions.

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?
Do you have a solid cancer (not a blood cancer)?
Has your doctor told you that your cancer has a KRAS G12D genetic mutation?
Is your cancer considered 'advanced' (meaning it has spread or is hard to treat)?
Are you willing to attend regular hospital/clinic visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, the study team will carry out various checks and tests. This includes blood tests, physical examinations, and scans to monitor your cancer and how your body is reacting to the treatment. You will receive the study medication, VS-7375, either by itself or along with other cancer treatments, likely through an infusion directly into your vein. The schedule for these treatments and visits will be carefully explained to you, but typically involves cycles of treatment followed by breaks.

Throughout the study, the team will closely watch for any side effects you might experience and will make sure you are comfortable. There will also be follow-up appointments after your treatment finishes to see how you are doing long-term. The total duration of your involvement could vary depending on how you respond to the treatment and the study plan, but detailed information will be provided by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new drug, VS-7375, helps to control or shrink your cancer, especially if other treatments haven't worked well for you. However, as with all new medicines, there are potential risks. You might experience side effects, which could range from mild to more serious. The study team will closely monitor you to manage any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Italy
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Unverified
France
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Unverified
Germany
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Unverified
Belgium

Common questions

What is a KRAS G12D mutation?

It's a specific change in a gene within your cancer cells. This change can make the cancer grow and spread, and this new drug is designed to specifically target it.

What does 'advanced solid tumor' mean?

It means the cancer affects a solid organ (not blood) and has either spread to other parts of your body or can no longer be treated effectively with standard therapies.

Will this drug cure my cancer?

This is an early-stage study, so it's too soon to say if it will cure cancer. The goal is to see if it can help control the cancer or shrink tumors.

What kind of side effects might I expect?

The study will closely monitor for all side effects. These can vary, and the study team will explain the known possibilities and how they plan to manage them.

What is the difference between Phase 1 and Phase 2 of the study?

Phase 1 focuses on finding a safe dose and understanding how the drug works in the body. Phase 2 then looks at how effective the drug is at treating the cancer at that safe dose.