Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Sotorasib, Panitumumab and a drug combination for patients with metastatic colorectal cancer with KRAS p.G12C mutation.

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

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

Featured sites

Sites that work closely with us on this trial

What is this trial about?

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

This study focuses on individuals with Metastatic Colorectal Cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The research specifically looks at patients who have a certain genetic change known as a KRAS p.G12C mutation. This mutation is a specific alteration in the DNA of cancer cells that can influence how the disease grows and responds to therapy.

The purpose of the study is to compare the effectiveness of different medication combinations in preventing the cancer from getting worse. One group will receive a combination of sotorasib, panitumumab, and FOLFIRI. FOLFIRI is a treatment plan that includes fluorouracil, irinotecan hydrochloride trihydrate, and calcium folinate, all of which are administered through intravenous use, meaning they are delivered directly into a vein. Another group will receive FOLFIRI either alone or combined with bevacizumab.

Participants will be assigned to one of these treatment groups to see which approach is better at managing the disease. The study will follow the progress of the cancer over time to observe how long the treatments keep the disease from spreading further or increasing in size.

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 different treatment groups through a process called randomization, which is a method used to ensure that the assignment to each group is fair and unbiased.

  2. Step 2

    Experimental treatment group

    If assigned to this group, you will receive a combination of three medications: panitumumab, fluorouracil, and irinotecan hydrochloride trihydrate, along with calcium folinate.

    panitumumab is administered through an intravenous use, which means it is delivered directly into a vein, at a dose of 6 mg/kg (milligrams per kilogram of body weight).

    fluorouracil is also administered through intravenous use at a dose of 2800 mg/m² (milligrams per square meter of body surface area).

    irinotecan hydrochloride trihydrate is administered through intravenous use at a dose of 180 mg/m².

    calcium folinate is administered through intravenous use at a dose of 400 mg/m².

    Additionally, you will take sotorasib by oral use, which means swallowing a pill, at a dose of 960 mg.

  3. Step 3

    Control treatment group

    If assigned to this group, you will receive fluorouracil and irinotecan hydrochloride trihydrate, which may be given with or without bevacizumab.

    fluorouracil is administered through intravenous use at a dose of 2800 mg/m².

    irinotecan hydrochloride trihydrate is administered through intravenous use at a dose of 180 mg/m².

    If bevacizumab is included in your treatment, it is administered through intravenous use at a dose of 5 mg/kg.

  4. Step 4

    Monitoring and evaluation

    During the study, the effectiveness of the treatment is monitored by looking at progression-free survival, which is the length of time during and after treatment that the disease does not get worse.

    The response of the tumor is evaluated to check for complete response (where all signs of cancer disappear) or partial response (where the cancer has decreased in size).

    Your health is monitored through assessments of vital signs, such as blood pressure and heart rate, and clinical laboratory tests to check your blood and other bodily functions.

Who can join the trial?

9 criteria

  • You must have a confirmed diagnosis of metastatic colorectal adenocarcinoma, which is a type of cancer that started in the colon or rectum and has spread to other parts of the body.
  • A central laboratory must confirm that you have a specific genetic change called a KRAS p.G12C mutation, which is a change in the DNA of the cancer cells.
  • Your cancer must be measurable using standard medical rules, meaning the tumors are large enough to be clearly seen and tracked on scans.
  • If a tumor was previously treated with radiation (high-energy beams used to kill cancer cells), it can only be counted if it has grown larger since the treatment ended.
  • You must be at least 18 years old or the legal adult age in your country.
  • You must have an ECOG Performance Status of 1 or less, which means you are physically able to carry out most daily activities and are only slightly limited by your illness.
  • A doctor must believe that you have a life expectancy of more than 6 months.
  • You must have adequate hematologic and end organ function, meaning your blood counts and your major organs, such as your liver and kidneys, are working well.
  • You must be able to swallow oral medications (pills or liquids taken by mouth) and be willing to keep a daily record of when you take the study medicine.

Who cannot join the trial?

5 criteria

  • You have active, untreated brain metastases, which means cancer that has spread to the brain and is currently growing and has not yet been treated.
  • You have leptomeningeal disease, which is a condition where cancer cells have spread to the thin protective layers that surround the brain and spinal cord.
  • You have previously taken a KRAS p.G12C inhibitor, which is a specific type of medicine designed to block a certain protein that helps cancer grow.
  • You have had to lower your dose or delay your treatment when taking 5-fluorouracil (5-FU) or irinotecan in any past chemotherapy treatments because of toxicity, which refers to harmful or unpleasant side effects caused by medication.
  • You have a history of interstitial pneumonitis or pulmonary fibrosis, which are conditions involving inflammation or scarring of the lung tissue, or if these conditions are visible on your initial CT scan (a special type of X-ray image used to look inside the body).
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 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

  • Panitumumab

    is a targeted therapy given through a vein that works by blocking certain signals that help cancer cells grow and divide.

  • Fluorouracil

    is a chemotherapy drug administered through a vein that works by interfering with the DNA of cancer cells, preventing them from multiplying.

  • Irinotecan

    is a chemotherapy medication given through a vein that helps stop the growth of cancer cells by blocking a specific enzyme that cancer cells need to replicate.

  • Sotorasib

    is an oral medication designed to target and block a specific mutated protein that helps cancer cells survive and grow.

  • Calcium folinate

    is a substance given through a vein that is used alongside certain chemotherapy drugs to help reduce their side effects and improve their effectiveness.

  • Bevacizumab

    is a therapy given through a vein that works by blocking the growth of new blood vessels that tumors need to receive nutrients and oxygen.

What is already known about the treatment

  • Panitumumab

    This medication is administered through an intravenous injection and is currently used in medical practice to treat certain types of advanced cancers. It works as a targeted therapy by attaching to specific receptors on the surface of cancer cells to block growth signals. This drug belongs to a class of medicines known as monoclonal antibodies.

  • Fluorouracil

    This substance is given via intravenous infusion and is a well-established treatment used for various types of cancer, including colorectal cancer. It functions as a chemotherapy agent by interfering with the DNA production that cancer cells need to multiply. It is scientifically classified as an antimetabolite.

  • Irinotecan hydrochloride trihydrate

    This medicine is administered through an intravenous line and is widely used in cancer treatment protocols. It works by inhibiting a specific enzyme that helps cancer cells repair their DNA, leading to cell death. This drug is classified as a topoisomerase inhibitor.

  • Sotorasib

    This medication is taken orally as a pill and is a newer treatment specifically studied for certain genetic mutations in cancer. It works at a molecular level by locking a specific mutated protein in an inactive state to stop cancer growth. It is classified as a targeted KRAS inhibitor.

  • Calcium folinate

    This substance is provided through an intravenous injection and is commonly used alongside certain chemotherapy drugs to manage their effects. It acts by helping the body process other medications more effectively and protecting healthy cells from excessive damage. It is classified as a vitamin derivative used to enhance chemotherapy.

  • Bevacizumab

    This medication is administered through an intravenous infusion and is a standard treatment used for many types of solid tumors. It works by blocking a specific protein that helps tumors grow new blood vessels, essentially cutting off their nutrient supply. It is classified as an angiogenesis inhibitor.

Investigated diseases

Colorectal cancer - This is a type of cancer that begins in the colon or the rectum. It often starts as small, noncancerous growths called polyps on the inner lining of the digestive tract. Over time, these polyps can undergo genetic changes and transform into malignant tumors. As the disease progresses, the cancer cells can grow into nearby tissues and potentially spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502352-31-00Protocol code20210081Estimated enrolment441 patientsSponsorAmgen 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.