Active not recruitingPHASE1INTERVENTIONAL

Phase I Trial of Defactinib and VS-6766.

This research trial is looking at a new combination of two drugs, Defactinib and VS-6766, for people living with advanced solid cancers. These cancers include specific types of lung cancer, a certain kind of ovarian cancer, womb cancer, and pancreatic cancer. The study is divided into two parts. The first part, which has now finished, focused on finding the safest and most effective dose of these two drugs when given together. The second part, which is currently ongoing, will involve more patients to further understand how safe the drugs are, how well people tolerate them, and to see if they help improve the cancer. The aim is to find better treatments for these advanced cancers.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

12 Dec 2017

Estimated completion

31 Oct 2026

NSCLC Low Grade Serous Ovarian Cancer Endometrioid Carcinoma Pancreatic Cancer

What is this study about?

This research study is investigating a new way to treat certain advanced cancers that have become difficult to treat with standard therapies. We are looking at combining two different medicines, called Defactinib and VS-6766. These drugs work in different ways to try and slow down or stop cancer growth. Defactinib targets a protein called FAK, and VS-6766 targets two other proteins called RAF and MEK, which are often involved in cancer development.

This study, like many new drug trials, is happening in two main stages. The first stage, which has now been completed, involved a small number of patients with various advanced cancers. The main goal here was to carefully increase the doses of the two drugs to find the highest dose that patients could safely tolerate, and to decide on the best dose to use in future studies. This stage helps us understand the drugs' immediate effects.

The second stage, which is currently open, is designed to gather more information. In this stage, a larger group of patients with specific types of advanced cancers will receive the combined treatment. This includes certain lung cancers, a type of ovarian cancer, some womb cancers, and pancreatic cancer. By studying more patients, we can learn more about how safe the treatment is over a longer period, how well people cope with any side effects, and crucially, if the treatment shows signs of being effective against these cancers. The drugs are taken by mouth, twice a week.

Key takeaways

This study is testing two new drugs for specific advanced cancers (lung, ovarian, womb, pancreas).
It's a 'dose expansion' phase, focusing on safety, tolerability, and early signs of effectiveness.
Open to patients with low-grade serous ovarian cancer, specific KRAS mutant lung cancers, RAS/RAF mutant womb cancers, and pancreatic cancer.
Patients take both drugs by mouth on specific schedules.
Participation involves regular hospital visits for monitoring and tests.
You can stop participating at any time.

Who may be eligible?

This study is for adults aged 18 or older who have certain types of advanced solid cancers that are no longer responding well to standard treatments, or for which there are no standard treatments available or preferred.

The types of cancer included in the current phase of the study are low-grade serous ovarian cancer, a specific type of lung cancer called KRAS G12V mutant non-small cell lung cancer, certain womb cancers (endometrioid cancers with RAS or RAF gene changes), and pancreatic cancer.

Patients might need to have a biopsy (a small tissue sample taken) if they are in one of the specific groups that require it. Your doctor will be able to tell you if your cancer type and other health conditions match the requirements for this study.

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 over?
Do you have advanced low-grade serous ovarian cancer, or specific KRAS mutant lung cancer, or RAS/RAF mutant endometrioid gynaecological cancer, or pancreatic cancer?
Has your cancer stopped responding well to usual treatments, or are there no standard treatments available?
Are you able to take medicines by mouth?
Are you willing to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you would take two medications, VS-6766 and Defactinib, by mouth. VS-6766 is taken twice a week, on specific days (like Monday/Thursday or Tuesday/Friday), at least one hour before or two hours after a meal. Defactinib is taken once a day.

Your participation would involve regular visits to the hospital for check-ups, blood tests, and scans to see how the treatment is working and to monitor any side effects. You will be closely monitored by the study team. The duration of your participation will depend on how you respond to the treatment and your overall health, but you can expect to have ongoing assessments and follow-up during the course of the study.

Potential risks and benefits

As with all medical treatments, there may be potential benefits and risks to taking part in this study. The potential benefit is that these new drugs might help control your cancer, especially if other treatments haven't worked well. However, because these are investigational drugs, we don't yet fully know their side effects or how effective they will be. There could be side effects, some of which might be serious. Before deciding, the study team will explain all known and potential risks to you. Remember, joining a clinical trial is always your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom
The Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom
The Royal Marsden NHS Foundation Trust - Gynecology Unit
Verified postcode
London, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Verified postcode
Newcastle, United Kingdom
The Royal Marsden NHS Foundation Trust - Gynecology Unit
Verified postcode
Sutton, United Kingdom

Common questions

What is a 'Phase I' trial?

A Phase I trial is the first step in testing a new drug or combination in humans. Its main goal is to find the safest dose and understand any side effects, rather than primarily looking at how well it treats the disease.

What does 'advanced solid tumours' mean?

This refers to cancers that have grown or spread from where they started and have formed solid lumps. 'Advanced' means they are no longer localised, which can make them harder to treat.

Are both drugs new?

Yes, both Defactinib and VS-6766 are investigational drugs, meaning they are still being studied and are not yet approved for general use.

What happens if the drugs don't work for me?

Your doctors will regularly monitor you to see how you are responding. If the drugs aren't helping, or if side effects become too difficult, the study team will discuss other treatment options with you.

Will I have to pay to be in the study?

No, all study-related treatments and tests are provided at no cost to you.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.