Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

INCA33890 With Standard Chemotherapy and Bevacizumab in First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

Verified siteRegistered drug
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 done in metastatic microsatellite stable colorectal cancer, which is a type of bowel cancer that has spread to other parts of the body and does not show a certain change in the tumor called microsatellite instability. The purpose of the study is to see whether adding INCA33890 to standard treatment works better than standard treatment alone.

The standard treatment in this study includes bevacizumab, oxaliplatin, fluorouracil, and calcium folinate. INCA33890 is given by vein, and the other medicines are also given as injections or infusions into a vein. People in the study are assigned by chance to one of two groups: one group receives INCA33890 with the standard treatment, and the other group receives placebo with the standard treatment. The study is blinded, which means the treatment group is not known to the people taking part or to the study team during the study.

After treatment starts, the study team follows how the cancer responds and how long the treatment helps keep the disease under control. The study also looks at how long people live and at side effects, which are unwanted health problems caused by a treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>randomization and start of treatment</b>

    You are assigned to one of two study groups by chance. The study is double-blind, which means you do not know which study treatment you receive, and the study team does not know either.

    One group receives inca33890 together with standard treatment. The other group receives placebo together with standard treatment. A placebo is a study product that looks like the active treatment but does not contain the active medicine.

    Your treatment begins for first-line treatment of metastatic microsatellite stable colorectal cancer. First-line means the first treatment given for this cancer. Metastatic means the cancer has spread to other parts of the body. Microsatellite stable means a specific feature of the cancer cells.

  2. Step 2

    <b>study treatment in the inca33890 group</b>

    If you are assigned to the inca33890 group, you receive inca33890 900 mg by intravenous infusion. Intravenous infusion means the medicine is given through a vein over time.

    The study information provided does not state how often inca33890 is given or how long each infusion lasts.

  3. Step 3

    <b>study treatment in the placebo group</b>

    If you are assigned to the placebo group, you receive a placebo infusion that contains the same buffer ingredients but no active medicine.

    The study information provided does not state how often the placebo is given or how long each infusion lasts.

  4. Step 4

    <b>standard-of-care treatment given in both study groups</b>

    In both study groups, you receive standard treatment with bevacizumab, oxaliplatin, fluorouracil, and calcium folinate.

    bevacizumab is given by intravenous infusion at a dose of 5 mg/kg.

    oxaliplatin is given by intravenous infusion at a dose of 85 mg/m2. The term m2 means square meters of body surface area.

    fluorouracil is given by infusion at a dose of 2800 mg/m2.

    calcium folinate is given by injection at a dose of 400 mg/m2.

    The study information provided does not state the frequency or duration of administration for these medicines.

  5. Step 5

    <b>follow-up during treatment</b>

    During the study, your cancer is checked to see whether it gets worse or responds to treatment.

    The main measure is progression-free survival, which means the time from randomization until the cancer gets worse for the first time or death from any cause.

    Other measures include overall survival, which means the time from randomization until death from any cause, and objective response, which means the cancer shrinks completely or partly.

    The study also checks how long the response lasts and whether you have treatment-emergent side effects. These are side effects that start or get worse after treatment begins.

    The study records whether side effects lead to a dose break or stopping the study medicine.

  6. Step 6

    <b>study end</b>

    The study is planned to run until the estimated end date of 2029-12-01.

    Your participation in the treatment phase ends when the study treatment period ends or when the study assessment period is complete, according to the study plan.

Who can join the trial?

9 criteria

  • Be able to understand the study information and be willing to sign a written informed consent form (ICF), which is a document saying you agree to join the study after being informed about it.
  • Be 18 years of age or older when signing the informed consent form.
  • Have metastatic colorectal adenocarcinoma confirmed by tissue testing, meaning the cancer started in the colon or rectum and has spread to other parts of the body, and the diagnosis was proven by looking at cells or tissue under a microscope.
  • Have Stage IV disease that cannot be removed completely with surgery, meaning the cancer is not suitable for a surgery that could cure it.
  • Have no previous systemic treatment for unresectable or metastatic colorectal cancer, meaning no prior treatment that travels through the whole body, such as chemotherapy, for cancer that cannot be removed or has spread.
  • May have had neoadjuvant or adjuvant treatment in the past, which means treatment given before surgery or after surgery, as long as the cancer did not come back within 12 months after the last systemic treatment.
  • Have measurable disease on scans, meaning the cancer spots can be seen and measured by imaging tests according to the study rules.
  • Have adequate organ function, meaning the major organs needed for the study, such as the liver, kidneys, and bone marrow, are working well enough according to the study requirements.
  • Be willing to avoid becoming pregnant or fathering a child during the study, meaning participants must take steps to prevent pregnancy if this applies to them.

Who cannot join the trial?

18 criteria

  • Known MSI-H/dMMR status in the medical record. This means the cancer is known to have a certain genetic pattern that is not allowed in this study.
  • History of an organ transplant, including allogeneic stem cell transplantation (a stem cell transplant from another person).
  • Active autoimmune disease that needed whole-body treatment in the past 2 years, such as disease-modifying drugs, steroids, or immunosuppressive drugs. Replacement treatment is allowed.
  • Any important ongoing medical problem, or a medical problem that is not well controlled, as defined by the study rules.
  • Uncontrolled active hepatitis B or hepatitis C infection.
  • HIV positive, unless all of these are true: the CD4+ count is at least 350 cells/μL, the virus is not detectable in the blood, and the person is taking highly active antiretroviral therapy (a strong combination treatment for HIV).
  • Current use of long-term whole-body corticosteroids (steroid medicines), meaning more than 10 mg/day of prednisone or a similar dose.
  • Received a live vaccine within 28 days before the first study treatment. A live vaccine contains a weakened form of a germ.
  • Current use of any prohibited medication listed in the study rules.
  • Known complete DPD deficiency in the medical record. DPD is an enzyme the body uses to break down certain medicines.
  • BRAF V600E mutation in the medical record. This is a specific change in a cancer gene.
  • Another cancer within the past 2 years before joining the study.
  • Untreated or progressing CNS metastases. CNS means the brain and spinal cord. This includes new or growing brain metastases, or new nerve-related symptoms caused by brain or CNS metastases.
  • Tumor that is known to grow into or wrap around a major blood vessel, or any history of important bleeding from the tumor within 30 days before joining the study.
  • Treatment in the past 3 years with an anti–PD-(L)1 antibody, an anti–CTLA-4 antibody, or any other drug that targets T-cell costimulation or checkpoint pathways. These are immune-system treatments.
  • Side effects from past treatment that have not improved to Grade 1 or back to the person’s usual level. Grade 1 means mild side effects. Grade 2 or higher numbness or tingling in the hands or feet from past chemotherapy, such as oxaliplatin, is also not allowed.
  • Receiving any other cancer treatment at the same time, except for the treatments being studied.
  • Received thoracic radiation of more than 30 Gy within 6 months before the first study treatment. Thoracic radiation means radiation to the chest, and Gy is a unit used to measure radiation dose.
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

  • INCA33890

    is the study drug being tested in this trial. It is given by intravenous infusion, meaning it goes directly into a vein through a drip. The study is checking whether adding INCA33890 to the usual treatment can help people with metastatic microsatellite stable colorectal cancer better than the usual treatment alone.

  • Bevacizumab

    is a medicine already used as part of the standard treatment in this trial. It is given by intravenous infusion. It helps slow the growth of cancer by blocking the blood supply that tumors need to grow.

  • Oxaliplatin

    is a chemotherapy medicine used as part of the usual treatment in this study. It is given by intravenous infusion. It works by damaging cancer cells so they can no longer grow and divide normally.

  • Fluorouracil

    is another chemotherapy medicine used in the standard treatment plan. It is given by infusion into a vein. It helps kill cancer cells or stop them from making new cells.

  • Calcium folinate

    is given together with fluorouracil as part of the standard chemotherapy treatment. It is given by injection. In this trial, it helps fluorouracil work better against the cancer.

What is already known about the treatment

  • INCA33890

    INCA33890 is given as an intravenous infusion, which means it is delivered directly into a vein by a healthcare professional. It is an investigational medicine, so it is still being studied and is not yet an established treatment in routine medical practice or the wider medical literature. In this trial, it is being tested for first-line treatment of metastatic microsatellite stable colorectal cancer, and its exact molecular target and drug class are not yet clearly defined in public sources. Because of this, it is best described as a new experimental cancer medicine under clinical investigation.

  • Bevacizumab

    Bevacizumab is given by intravenous infusion, usually through a vein in a clinic or hospital. It is a well-known and widely used cancer medicine that is already approved in medical practice for several cancers, including colorectal cancer. It works by blocking a signal called VEGF, which tumors use to build new blood vessels; by cutting off this blood supply, it can slow tumor growth. It belongs to the class of targeted cancer medicines called monoclonal antibodies.

  • Oxaliplatin

    Oxaliplatin is given by intravenous infusion and is administered by a healthcare professional. It is an established chemotherapy medicine that is commonly used in colorectal cancer and is well described in medical literature. It works by damaging the DNA inside cancer cells, which stops them from growing and dividing. It belongs to the platinum-based chemotherapy class.

  • Fluorouracil

    Fluorouracil is given as a solution for infusion, meaning it is delivered into a vein under medical supervision. It is a long-established and widely used cancer medicine, especially in colorectal cancer, and it has a strong place in medical practice and research. It works by blocking the making of DNA and RNA, which cancer cells need to grow and multiply. It belongs to the class of antimetabolite chemotherapy medicines, also called pyrimidine analogs.

  • Calcium folinate

    Calcium folinate is given as a solution for injection, usually into a vein, and is administered by a healthcare professional. It is an established medicine in cancer treatment and is also used in medical practice to reduce the harmful effects of some other medicines. In colorectal cancer treatment, it is often given with fluorouracil to help fluorouracil work better by strengthening its effect on cancer cells. It belongs to the class of folate-related medicines and is also known as leucovorin.

Investigated diseases

Metastatic Microsatellite Stable Colorectal Cancer - This is colorectal cancer that has spread from the colon or rectum to other parts of the body. It begins in the lining of the large intestine and gradually grows deeper and may form tumors in nearby tissues and distant organs. The term microsatellite stable means the cancer cells do not show a specific pattern of DNA instability. As the disease progresses, the cancer can become more widespread and involve multiple areas of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523735-19-00Protocol codeINCA033890-303Estimated enrolment700 patientsSponsorIncyte Corp.

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.