Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A Study Comparing PF-08634404 and a Drug Combination with Chemotherapy in Adults with Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study is being conducted to evaluate the effectiveness and safety of a new treatment option for individuals with Metastatic Colorectal Cancer. This type of cancer occurs when cancer that started in the colon or rectum spreads to other parts of the body. The research compares two different treatment approaches. One approach uses the study drug PF-08634404 combined with chemotherapy, which is a type of treatment that uses strong medicines to kill fast-growing cancer cells. The chemotherapy used in this study consists of oxaliplatin, calcium folinate, and fluorouracil, which are administered through intravenous infusion, meaning they are delivered directly into a vein. The other approach uses bevacizumab combined with the same chemotherapy medicines.

Participants in the study will be assigned to one of the two treatment groups through a process called randomization, which is similar to drawing lots to decide which group a person joins. To ensure the results are unbiased, a double-blind method is used, meaning that neither the participants nor the researchers know which specific treatment is being given during the course of the study. The study will monitor how long the cancer remains stable and how long participants live to determine if the new combination is more effective than the current 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.

  1. Step 1

    Study assignment

    You will be assigned to one of two groups through a process called randomization, which is similar to drawing lots. this determines whether you receive the experimental treatment or the comparison treatment.

  2. Step 2

    Experimental treatment group

    If assigned to this group, you will receive a combination of pf-08634404 and chemotherapy. chemotherapy is a type of medicine used to treat cancer using drugs delivered through an intravenous infusion, which is a liquid medicine passed into a vein.

  3. Step 3

    Comparison treatment group

    If assigned to this group, you will receive a combination of bevacizumab and chemotherapy via intravenous infusion.

  4. Step 4

    Monitoring and evaluation

    During the study, your health is monitored to evaluate progression-free survival, which is the length of time during and after treatment that a disease does not get worse, and overall survival, which is the length of time from the start of treatment that you are still alive.

Who can join the trial?

12 criteria

  • You must be 18 years of age or older at the time of the initial evaluation.
  • Women who are able to become pregnant must have a negative pregnancy test within 72 hours before receiving the first dose of the study treatment.
  • You must provide informed consent, which means you agree to participate after being fully explained the details of the study.
  • A doctor must confirm through a tissue sample that you have colorectal adenocarcinoma, which is a specific type of cancer that starts in the cells of the colon or rectum.
  • You must have Stage IV metastatic disease, which means the cancer has spread from its original location to other parts of the body.
  • Your RAS mutation status must be known, which refers to specific changes or "errors" in your DNA within the RAS genes that can affect how cancer grows.
  • You must not have received any prior systemic therapy, meaning you have not taken any medicines (like chemotherapy) that travel through the whole body to treat the spread cancer.
  • You must have an ECOG performance status of 0-1, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
  • You must have at least one measurable lesion, which is a tumor or area of cancer that is large enough for doctors to clearly see and track using medical imaging.
  • You must have tumor tissue available, such as a small piece of the tumor from a biopsy, so it can be tested in a laboratory.
  • You must have adequate hematologic, hepatic, and renal function, meaning your blood counts, liver function, and kidney function must all be working at a healthy level.
  • Your blood counts must be stable without the use of transfusions (extra blood or platelets given to you) or growth factors (medicines used to help your body make more blood cells) for at least 7 days before testing.

Who cannot join the trial?

22 criteria

  • Having a specific genetic change in the tumor called a BRAF V600E mutation.
  • Having serious heart problems within the last 6 months, such as unstable angina (chest pain that is unpredictable), a myocardial infarction (heart attack), irregular heartbeats like arrhythmia, or congestive heart failure (a condition where the heart cannot pump enough blood).
  • Having a heart rhythm abnormality on an ECG (an electrical test of the heart) known as a QTcF interval longer than 480 msec.
  • Having serious liver disease such as decompensated liver cirrhosis (advanced scarring of the liver that prevents it from working properly).
  • Having nephrotic syndrome (a kidney disorder that causes the body to pass too much protein in the urine).
  • Having uncontrolled high blood pressure (hypertension) or a hypertensive crisis (a sudden, severe increase in blood pressure).
  • Having experienced blood clots in the arteries or veins, such as a thromboembolic event.
  • Having active autoimmune diseases (conditions where the immune system attacks healthy cells) that required treatment with systemic drugs, such as corticosteroids or immunosuppressants, within the last 2 years.
  • Having ILD pneumonitis (inflammation of the lung tissue that is not caused by an infection) that was treated with steroids or is currently being managed with medicine.
  • Having unresolved side effects from previous cancer treatments that have not improved to a mild or no-symptom level, except for alopecia (hair loss).
  • Having significant neuropathy (nerve damage that causes numbness or tingling), especially if caused by a previous medicine called oxaliplatin.
  • Having a history of stomach or intestinal issues in the last 6 months, such as esophageal varices (swollen veins in the food pipe), ulcers, gastrointestinal perforation (a hole in the stomach or intestines), or gastrointestinal bleeding.
  • Having another type of cancer within the last 3 years, unless it was a very low-risk type.
  • Having an allergy or hypersensitivity to any of the ingredients used in the study medicines.
  • Having MSI-high or dMMR colorectal cancer, which are specific biological markers in certain tumors.
  • Having active cancer that has spread to the Central Nervous System (the brain or spinal cord), unless the brain cancer has been treated and is stable.
  • Having a DPD deficiency (a condition where the body lacks an enzyme needed to break down certain chemotherapy drugs).
  • Having a high risk of bleeding or a fistula (an abnormal connection between two organs or between an organ and the skin) due to the location or size of the tumor.
  • Having undergone major surgery or experienced severe trauma within the last 4 weeks.
  • Having a history of receiving an organ transplant or a stem cell transplant.
  • Having severe bleeding or hemorrhage events within the last 28 days.
  • Having an active infection, such as HIV, Hepatitis B (HBV), Hepatitis C (HCV), or Tuberculosis (TB), unless the infection is well-controlled with medicine.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • PF-08634404

    is an experimental drug being tested to see if it can help treat metastatic colorectal cancer when used alongside chemotherapy.

  • Oxaliplatin

    is a type of chemotherapy drug used to help stop the growth of cancer cells.

  • Calcium folinate

    is a substance used in this study to help the chemotherapy work more effectively.

  • Fluorouracil

    is a common chemotherapy medication used to treat various types of cancer.

  • Bevacizumab

    is a medication used in this study to target and block certain proteins that help cancer tumors grow and develop new blood supplies.

What is already known about the treatment

  • Bevacizumab

    This medication is an established treatment administered through an intravenous infusion to help fight various types of cancer. It belongs to a class of drugs called monoclonal antibodies that work by blocking a specific protein called VEGF, which helps tumors grow new blood vessels to feed themselves. By cutting off this blood supply, the drug aims to slow down or stop the growth of cancer cells.

  • Oxaliplatin

    This is a well-known chemotherapy drug given directly into a vein to treat several types of advanced cancer. It is classified as a platinum-based antineoplastic agent that works by binding to the DNA inside cancer cells. This process damages the cell's genetic material, preventing the cancer cells from multiplying and eventually causing them to die.

  • Calcium Folinate

    This substance is administered intravenously and is commonly used alongside certain chemotherapy drugs to manage their effects. It acts as a specialized form of vitamin B, helping to influence how the body processes specific cancer medications at a molecular level. Its main role is to protect healthy cells or enhance the effectiveness of the treatment being used.

  • Fluorouracil

    This is a widely used chemotherapy medication delivered through an intravenous infusion to treat various cancers, including colorectal cancer. It belongs to a group of drugs known as antimetabolites, which trick cancer cells by mimicking the building blocks of DNA. Once inside the cell, it interferes with the production of genetic material, effectively stopping the cancer cells from growing and dividing.

  • PF-08634404

    This is an experimental drug currently being studied in clinical trials and is administered via an intravenous infusion. As a new type of targeted therapy, it is designed to interfere with specific molecular signals that cancer cells use to grow and survive. This medication is being tested to see if it can improve survival outcomes for patients with metastatic colorectal cancer when used in combination with chemotherapy.

Investigated diseases

Metastatic Colorectal Cancer - This is a type of cancer that starts in the cells of the colon or rectum. The disease occurs when abnormal cells grow uncontrollably in the digestive tract. As the condition progresses, these cancer cells can break away from the original site. They travel through the bloodstream or the lymphatic system to reach other parts of the body. Once they reach new organs, they form new growths known as secondary tumors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523521-18-00Protocol codeC6461003Estimated enrolment800 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.