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Study of precemtabart tocentecan alone or in drug combination versus standard therapy in previously treated metastatic colorectal cancer patients

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study involves adults with metastatic colorectal cancer, a type of cancer that began in the colon or rectum and has spread to other parts of the body. One treatment being tested is an experimental drug called Precemtabart Tocentecan, which is given through an infusion (a slow drip into a vein). Another drug used in the study is bevacizumab, a medication that blocks the growth of new blood vessels that tumors need to grow. The standard comparison treatment combines two chemotherapy agents, trifluridine and tipiracil, taken as pills together with bevacizumab.

The purpose of the study is to determine whether the experimental drug, alone or together with the blood‑vessel‑blocking drug, can improve overall survival compared with the standard pill combination plus the blood‑vessel‑blocking drug.

Participants are randomly placed into one of three groups: one group receives the experimental drug alone, a second group receives the experimental drug combined with the blood‑vessel‑blocking drug, and a third group receives the standard pill combination together with the blood‑vessel‑blocking drug. Treatments are given in repeated cycles, and participants have regular clinic visits for check‑ups, blood tests, imaging scans, and monitoring for side effects. The study continues until the disease progresses or the treatment can no longer be tolerated.

The research process

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

  1. Step 1

    Baseline assessments

    After you join the study, you will have an initial visit where the clinical team records your medical history, performs a physical examination, and collects blood samples and imaging studies. these assessments establish a reference point for later comparisons.

  2. Step 2

    Randomization to a treatment arm

    Based on a computer‑generated schedule, you will be assigned to one of three groups. the assignment is made without your input and determines which medication(s) you will receive during the trial.

  3. Step 3

    Start of study medication

    If you are placed in arm 1, you will receive precemtabart tocentecan by intravenous infusion at a dose of 2.8 mg per kilogram of body weight. the infusion is given on the day specified by the protocol.

    If you are placed in arm 2, you will receive the same dose of precemtabart tocentecan (2.8 mg/kg iv) together with bevacizumab by intravenous infusion at a dose of 7.5 mg per kilogram of body weight. both infusions are administered on the scheduled day.

    If you are placed in arm 3, you will take trifluridine and tipiracil tablets (commercially known as lonsurf) by mouth. the tablets contain a total dose of 70 mg per square meter of body‑surface area. you will swallow the tablets according to the schedule defined by the study team. in addition, you will receive bevacizumab by intravenous infusion at 7.5 mg/kg on the same day as the oral medication.

  4. Step 4

    Regular monitoring visits

    Throughout the treatment period you will attend follow‑up visits. during each visit the staff will repeat blood tests, perform imaging scans, and ask you to complete quality‑of‑life questionnaires. any side effects you experience will be recorded and managed according to the study protocol.

  5. Step 5

    Continuation and study completion

    You will continue receiving the assigned medication(s) and attending monitoring visits until the study protocol indicates stopping, which may be due to disease progression, unacceptable side effects, or the predefined end of the trial. the overall study period is expected to run until october 31, 2029.

Who can join the trial?

7 criteria

  • Have a confirmed diagnosis of metastatic colorectal cancer (cancer that began in the colon or rectum and has spread to other parts of the body) based on tissue testing.
  • Have disease that did not respond to, stopped responding to, or got worse after standard treatments, and have had no more than two different systemic treatment regimens (medications that affect the whole body) for the metastatic cancer.
  • Have an ECOG Performance Status of 0 or 1 (a simple scale that shows how well you can perform daily activities; 0 means fully active, 1 means limited in strenuous activity but still able to do light work).
  • Be able to swallow oral tablets.
  • Be willing and able to attend all scheduled study visits and follow the study procedures.
  • Be an adult (usually 18 years or older) of any gender.
  • Meet any other specific requirements that the study protocol may define.

Who cannot join the trial?

6 criteria

  • If you still have side effects from previous cancer treatments that are worse than a mild level (called Grade 1) according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (CTCAE), you cannot join.
  • If you have had another type of cancer diagnosed within the three years before the study starts (this is called an additional malignancy), you are not eligible.
  • If cancer has spread to your brain (known as brain metastases), you cannot participate.
  • If you have had an abdominal fistula (an abnormal connection between organs), a hole in the digestive tract (gastrointestinal perforation), or an infected pocket of pus inside the abdomen (intra-abdominal abscess) in the last six months, you are excluded.
  • If you have a bowel slowdown called ileus that is at least mild (Grade 1), or have long‑lasting inflammatory bowel diseases such as ulcerative colitis or Crohn’s disease, or have a blockage in the intestines (bowel obstruction), or other chronic gut problems that might stop the study medicines from being absorbed properly, you cannot join.
  • Other study‑specific rules may also prevent participation.
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Investigated drugs

  • Lonsurf

    is an oral tablet that contains two medicines, trifluridine and tipiracil. It is used to treat metastatic colorectal cancer that has already been treated with other drugs. In this study, Lonsurf is given together with bevacizumab and serves as the standard treatment that the new drugs are compared against.

  • Avastin

    is the brand name for bevacizumab, a medication given through an IV infusion. Bevacizumab works by blocking signals that tell tumors to grow new blood vessels, which can slow down cancer growth. In this trial, Avastin is part of the standard treatment (combined with Lonsurf) and is also combined with the experimental drug M9140 in one of the test groups.

  • M9140

    is the code name for an investigational drug called precemtabart tocentecan. It is administered by IV infusion and is being studied to see if it can improve overall survival in patients with previously treated metastatic colorectal cancer. The study tests M9140 both by itself and together with bevacizumab.

What is already known about the treatment

  • Trifluridine/Tipiracil

    This medication is taken by mouth as a film‑coated tablet. It is an approved chemotherapy drug used for metastatic colorectal cancer that has already been treated with other therapies. The drug works by adding faulty building blocks into the DNA of cancer cells, which stops them from dividing and leads to their death. It belongs to the class of antimetabolite chemotherapies.

  • Bevacizumab

    Bevacizumab is given by intravenous infusion, usually through a vein in the arm. It is an approved cancer treatment that is added to other drugs for metastatic colorectal cancer and several other solid tumors. It works by attaching to a protein called VEGF, preventing new blood vessels from forming and thus starving the tumor of nutrients. This drug is classified as a monoclonal antibody that blocks angiogenesis.

  • PrecEMTABART Tocentecan

    PrecEMTABART Tocentecan is supplied as a powder that is mixed with liquid and given by intravenous infusion. It is still an experimental medicine being studied in clinical trials for patients with metastatic colorectal cancer. The agent is designed to damage the DNA of cancer cells directly, causing them to stop growing and to die. It is being investigated as a novel cytotoxic chemotherapy.

Investigated diseases

Metastatic colorectal cancer - It is a type of cancer that begins in the colon or rectum and later spreads to other parts of the body. The disease starts as a growth in the large intestine that can grow larger and invade nearby tissues. Cancer cells may travel through the bloodstream or lymph system to reach distant organs such as the liver, lungs, or peritoneum. As more sites become involved, the overall burden of disease increases, leading to a gradual worsening of symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524648-37-00Protocol codeMS914001_0002Estimated enrolment1 020 patientsSponsorMerck Healthcare KGaA

sourced from the EU Clinical Trials Register and site verification

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