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Study of WEF-001 safety and effectiveness 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 focuses on patients with KRAS-mutant solid tumors, which are advanced forms of cancer that have a specific genetic change. The study will test a new experimental medication called WEF-001, which is given through intravenous injection. The treatment will be investigated in various types of cancer, including pancreatic cancer, colorectal cancer, non-small cell lung cancer, ovarian cancer, cholangiocarcinoma, and bladder cancer.

The purpose of this research is to understand how safe the medication is and how well patients tolerate it, while also examining its effectiveness against these types of cancer. The study is divided into two parts. In the first part, researchers will determine the safe dose of the medication. In the second part, they will focus on how well the treatment works in fighting the cancer.

During the study, participants will receive WEF-001 as a single treatment. The medication will be given in the form of a powder that is mixed with liquid and then administered through a vein. Participants will be monitored regularly to check their response to the treatment and any side effects that may occur. The study will include patients whose cancer has continued to grow after trying at least one standard treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and eligibility confirmation
Your age must be 18 years or older
You must have confirmed advanced or metastatic KRAS-mutant tumor
Your disease must have progressed after at least one standard treatment
Your ECOG performance status (measure of daily living abilities) must be less than 1
Laboratory tests will confirm your organ function is adequate
Step 2
Treatment phase - Phase 1
You will receive WEF-001 through an intravenous (IV) injection
The medication comes as a powder that will be dissolved for injection
Your treatment will be monitored for side effects and safety
Regular blood samples will be taken to measure how the drug moves through your body
Imaging scans will be performed to measure tumor response
Step 3
Treatment phase - Phase 2a
This phase focuses on measuring how well WEF-001 works against the tumor
Treatment continues through IV injection
Regular scans will track changes in tumor size
Blood tests will continue to monitor drug levels and safety
Your response to treatment will be measured using standard criteria (RECIST v1.1)
Step 4
Monitoring and follow-up
Your side effects will be tracked and graded according to standard criteria
Any need for dose adjustments will be evaluated
The study will track how long the treatment remains effective
The trial is expected to continue until January 2029

Who can join the trial?

8 criteria

Must be at least 18 years old when signing the consent form
Must have confirmed advanced or spreading (metastatic) cancer with KRAS mutation (a specific genetic change in tumor cells) in one of these types: - Pancreatic cancer - Colorectal cancer (cancer of large intestine) - Non-small cell lung cancer - Ovarian cancer resistant to platinum treatment - Bile duct cancer - Bladder cancer
Must have worsening disease after receiving at least one standard treatment. Special requirements: - Patients with specific colorectal cancer type (MSI-H/dMMR) must have previously received immunotherapy - If approved targeted therapy exists for your specific tumor type, you must have received it
Must have tumors that can be measured using standard imaging methods
Must have good physical ability to perform daily activities (ECOG score less than 1)
Must have recovered from side effects of previous treatments (except hair loss). Ongoing hormone problems that are properly treated with medication are acceptable
Must have suitable veins for blood draws and receiving medication through IV
Must have adequate organ function as shown by blood test results. If taking blood thinners, special consideration may be given after discussion with the study doctor

Who cannot join the trial?

14 criteria

Age below 18 years old
Presence of active brain tumors or brain metastases (cancer that has spread to the brain) requiring treatment
Pregnant or breastfeeding women
History of another cancer within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Severe heart conditions including:
- Uncontrolled high blood pressure
- Unstable heart disease
- Heart attack within the past 6 months
- Severe liver problems (liver function tests more than 3 times the normal upper limit)
- Severe kidney problems (creatinine clearance less than 30 mL/min)
- Active, uncontrolled infections requiring treatment
- Known HIV (Human Immunodeficiency Virus) infection
- Active hepatitis B or C infection
- Previous treatment with similar experimental drugs within the past 4 weeks
- Any medical condition that, in the opinion of the study doctor, would make it unsafe to participate in the trial

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Verified sites

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Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain

Trial locations

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Investigated drugs

WEF-001 is an investigational drug being studied for treating advanced solid tumors that have KRAS mutations. This medication is being tested as a standalone treatment (monotherapy) to understand how well it works against tumors. The trial aims to determine how safe the medication is and how well patients can tolerate it. This is the first time this drug is being tested in humans to establish the right dose for future treatments.

WEF-001

What is already known about the treatment

WEF-001 - An investigational drug currently being studied in Phase 1/2a clinical trials for the treatment of advanced solid tumors with KRAS mutations. This novel therapeutic agent is being evaluated for its safety, tolerability, and potential anti-tumor activity in cancer patients. The medication's primary focus is on targeting KRAS-mutant tumors, which have historically been challenging to treat with conventional therapies. While the specific administration method is still under investigation in the clinical trial, the drug is being studied as a monotherapy to determine its maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for future development.

Investigated diseases

KRAS-Mutant Solid Tumors - A condition where solid tumors develop due to mutations in the KRAS gene, which normally helps control cell growth and division. These tumors can form in various organs and tissues of the body when the mutated KRAS gene causes cells to grow and multiply uncontrollably. The mutation disrupts normal cellular signaling pathways, leading to the formation of abnormal tissue masses. The condition typically progresses through the growth and potential spread of these tumors to different locations in the body.