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A study to investigate the safety and effectiveness of WEF-001 in patients with advanced KRAS-mutant solid tumors

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at people who have advanced KRAS-mutant solid tumours, which are cancers that have spread or cannot be removed by surgery and carry a specific genetic change called a KRAS mutation. The types of cancers being studied include pancreatic cancer, colorectal cancer, non-small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma (a cancer of the bile ducts), and urothelial bladder cancer. The treatment being tested is called WEF-001, which is given through a vein as an intravenous injection after being prepared from a powder. The purpose of the study is to check how safe WEF-001 is, how well it is tolerated by the body, how the body processes the medicine, and whether it can help shrink or control the growth of tumours.

The study is divided into two parts. In the first part, called Phase 1, the researchers will test different doses of WEF-001 to find out which dose is safe and appropriate for further testing. They will closely watch for any side effects and measure how the medicine moves through the body. In the second part, called Phase 2a, the study will focus on one specific type of cancer from among pancreatic cancer, colorectal cancer, or non-small cell lung cancer, and will test whether WEF-001 can help shrink tumours at the dose chosen from Phase 1.

People taking part in the study must have already tried at least one standard treatment for their cancer that did not work or stopped working. During the study, participants will receive WEF-001 and will have regular check-ups that include blood tests, scans to measure tumours, and monitoring for any side effects. The study will continue to follow participants to see how long the treatment works and how it affects their overall health. Some participants may also have tissue samples taken from their tumour to help researchers learn more about how WEF-001 works.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the study, your treatment with WEF-001 will begin. This medication is given through a vein in your arm, which is called intravenous administration.
The medication comes as a powder that will be mixed with liquid before being given to you as an injection.
The dose you receive will depend on which phase of the study you are in. The study team will determine the appropriate dose based on the study protocol.
Step 2
Regular monitoring visits
Throughout the study, you will attend regular visits where the study team will check your health and how you are responding to the treatment.
During these visits, blood samples will be taken to check how your body processes the medication and to monitor your organ function.
Your disease will be measured using imaging scans to see if the treatment is working. This will be done according to a standard method called RECIST v1.1, which is a set of rules for measuring tumors.
The study team will monitor you for any side effects or unwanted reactions to the medication.
Step 3
Safety assessments
Your safety will be closely monitored throughout the study. The study team will record any side effects you experience, including their type and severity.
Laboratory tests will be performed regularly to check your blood counts, liver function, kidney function, and other important health markers.
If you experience significant side effects, your dose may be adjusted, temporarily stopped, or discontinued depending on the severity.
Any serious health events will be carefully documented and managed by the study team.
Step 4
Response evaluation
Your tumor will be assessed at regular intervals to determine how well the treatment is working.
The study team will evaluate whether your tumor has shrunk, stayed the same size, or grown.
These assessments will help determine your overall response rate, which means whether your tumor responded to treatment.
The study team will also measure how long any response to treatment lasts and how long you remain without your disease getting worse.
Step 5
Continued treatment
You will continue receiving WEF-001 as long as your disease is not getting worse and you are tolerating the treatment without unacceptable side effects.
The frequency and duration of your treatment will be determined by the study protocol and your individual response.
Your participation in the study will continue until your disease progresses, you experience unacceptable side effects, you decide to withdraw, or the study ends.

Who can join the trial?

8 criteria

You must be 18 years old or older when you sign the consent form to join this study.
You must have a confirmed diagnosis of advanced or spread cancer with a specific genetic change called KRAS mutation, which is an alteration in your cancer cells that affects how they grow. The cancer types include pancreatic cancer, colorectal cancer, lung cancer, certain ovarian cancers, bile duct cancer, or bladder cancer.
Your cancer must have gotten worse after receiving at least one standard treatment. If you have colorectal cancer with certain genetic features called MSI-H or dMMR, which means your cancer cells have problems repairing their genetic material, you must have already tried a type of immune therapy called a PD-1 inhibitor. If your cancer has specific genetic changes for which approved targeted treatments exist, you should have already received those treatments.
Your cancer must be measurable by imaging scans according to standard guidelines called RECIST v1.1, which is a system doctors use to measure tumor size and response to treatment.
Your general health and ability to perform daily activities must be good, rated as less than 1 on a scale called ECOG performance status, which measures how cancer affects your daily living abilities.
You must have recovered from significant side effects of previous treatments to a mild level or back to your normal state, except for hair loss. If you have hormone problems from previous treatments that are controlled with replacement medications for thyroid, adrenal glands, or pituitary gland, you may still join.
You must have suitable veins that allow blood samples to be taken and medication to be given through an IV, which is a small tube inserted into a vein.
Your organs must be working well enough, shown by specific blood test results. If you are taking blood thinning medications, certain blood clotting test results may be acceptable if they are within the expected range for your medication.

Who cannot join the trial?

4 criteria

The study document does not provide specific exclusion criteria, which are reasons why a patient cannot participate in this clinical trial.
If you are interested in this study, the research team will need to review your complete medical history to determine if you are eligible to participate.
General factors that often prevent participation in cancer studies may include: having certain other medical conditions, taking specific medications, recent participation in other research studies, or having certain abnormal laboratory test results.
The research doctor will discuss with you whether this study is appropriate for your situation during the screening process.

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Verified sites

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Hospital Universitario Quironsalud Madrid
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Pozuelo De Alarcon, Spain

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Investigated drugs

WEF-001 is an experimental medication being tested in this clinical trial. It is designed to treat advanced solid tumors that have a specific genetic change called a KRAS mutation. This is a new treatment that is being studied to see how safe it is, how well the body processes it, and whether it can help shrink or control the growth of tumors in patients with this type of cancer.

WEF-001

What is already known about the treatment

WEF-001 – WEF-001 is an experimental cancer medication currently being studied in early-phase clinical trials for the treatment of advanced solid tumors that have a specific genetic change called KRAS mutation. This drug is administered as a single treatment (monotherapy) and is being tested to determine the safest and most effective dose, as well as how well it works against cancer. The medication works by targeting cells with KRAS mutations, which are genetic alterations that cause cancer cells to grow uncontrollably. At this time, WEF-001 is still in the research phase and has not yet been approved for general medical use, as scientists are evaluating its safety, how the body processes it, and its ability to shrink tumors in patients with KRAS-mutant cancers.

Investigated diseases

KRAS-Mutant Advanced Solid Tumors – This condition refers to cancers that have spread or grown extensively in various parts of the body and contain a specific genetic mutation in the KRAS gene. The KRAS gene normally helps control cell growth, but when it is mutated, cells can grow and divide uncontrollably, leading to tumor formation. These tumors can develop in different organs and tissues throughout the body. The mutation causes the cells to ignore normal signals that would stop their growth. As the disease progresses, the tumors continue to grow and may affect surrounding tissues. The advanced stage indicates that the cancer has progressed significantly from its original location.