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A phase 1/2 study evaluating safety, pharmacokinetics and efficacy of SOT109 in patients with advanced unresectable or metastatic colorectal cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study examines patients with advanced unresectable or metastatic colorectal cancer, a type of cancer that starts in the colon or rectum and has spread beyond the original site and cannot be removed by surgery. The investigational medicine being tested is SOT109, given as an intravenous infusion. The aim of the trial is to determine how safe the drug is, how the body handles it (pharmacokinetics), and whether it shows early signs of working against the cancer.

The trial begins with a dose‑finding stage where small groups receive increasing amounts of the drug to identify the highest dose that can be given without unacceptable side effects. After this, two recommended dose levels are tested more extensively. Participants receive the medication through a needle placed in a vein, usually once every few weeks, and are followed with scans that use the RECIST criteria to see if tumors shrink. The presence of the protein marker CDH17 in tumor tissue may be examined to explore any link with response. Safety is checked by looking for side effects, especially those that are serious enough to stop treatment, called dose‑limiting toxicities. Early effectiveness is measured by the proportion of patients whose tumors shrink, known as the objective response rate.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After joining the study, you will undergo initial medical tests, including blood work and imaging scans, to document the extent of your advanced colorectal cancer.

    These assessments create a reference point for later comparison and help the study team confirm that you meet the study criteria.

  2. Step 2

    Start of Part A – Dose Escalation

    You will receive SOT109 as an intravenous infusion, delivered through a vein using a sterile solution.

    The exact amount of drug, how often it is given, and the length of each infusion are determined by the study protocol and may be adjusted as the trial progresses.

    Each infusion is followed by observation for immediate reactions and collection of blood samples to measure how the drug behaves in your body.

  3. Step 3

    Safety and Pharmacokinetic Monitoring

    After each infusion, you will have regular safety checks, including physical examinations, laboratory tests, and recording of any side effects.

    Additional blood samples will be taken to assess the concentration of SOT109 and its components, helping researchers understand the drug’s pharmacokinetics.

  4. Step 4

    Dose‑Level Decision

    Based on the safety data collected, the study team will decide whether to keep the current dose, increase it, or stop treatment.

    If the dose is tolerated, you may receive a higher dose in the next treatment cycle as part of the dose‑escalation process.

  5. Step 5

    Transition to Part B – Dose Optimization

    If you continue in the trial, you will move to the dose‑optimization phase, where you will receive one of two recommended dose levels of SOT109 as a single‑agent therapy.

    The infusion method remains the same (intravenous), and the schedule follows the study’s defined intervals.

    Safety monitoring continues, with close attention to any treatment‑emergent adverse events.

  6. Step 6

    Efficacy Assessments

    Periodically, imaging studies such as CT scans will be performed to evaluate tumor response.

    Responses are measured using the RECIST 1.1 criteria, which compare the size of tumors before and after treatment.

    The duration of any observed response will also be recorded.

  7. Step 7

    Ongoing Follow‑Up

    Throughout the study, you will attend scheduled visits for continued safety checks, laboratory testing, and imaging as required.

    These visits continue until the study ends, you experience unacceptable toxicity, or you choose to discontinue.

Who can join the trial?

9 criteria

  • Be an adult aged 18 years or older.
  • Have advanced unresectable or metastatic colorectal cancer that has been confirmed by looking at the cancer cells under a microscope (histologically or cytologically confirmed).
  • Have cancer that has gotten worse after, or cannot be treated with, all standard therapies that are appropriate for you, or you could not tolerate those treatments.
  • Have at least one tumor that can be measured or evaluated using a standard method called RECIST v1.1 (a way doctors track tumor size).
  • Have an ECOG performance status of 0 or 1, which means you are fully active or able to do light work; people with a status of 2 (limited ability) may be considered after discussion.
  • Have adequate blood, liver, kidney, and heart function (adequate hematologic, hepatic, renal, and cardiac function), meaning your body’s major systems are working well enough for the study.
  • Have a life expectancy of at least 3 months.
  • Be willing to provide a sample of tumor tissue, either from previous records (archival) or a fresh sample if the study requires it.
  • Be able to understand the study information and sign the informed consent form.

Who cannot join the trial?

10 criteria

  • Prior treatment with SOT109 or a known allergy (hypersensitivity, meaning an allergic reaction) to any part of the study drug.
  • Any other health problem that the doctor believes would make it difficult for you to take part in the study or could change the study results.
  • Active or uncontrolled infections, including serious viral infections. “Active” means the infection is currently present, and “uncontrolled” means it is not being effectively treated.
  • Symptoms from cancer that has spread to the brain or spinal cord (central nervous system metastases) or such spread that has not been treated.
  • Significant heart or blood‑vessel disease (cardiovascular disease) or other serious health issues that are not under good control.
  • A past history of lung scarring conditions such as interstitial lung disease or inflammation of the lung tissue (pneumonitis) that needed treatment.
  • Peripheral nerve damage (called peripheral neuropathy) that is moderate or worse (grade 2 or higher). This means tingling, numbness, or pain in the hands or feet that is noticeable.
  • Active stomach or intestinal problems that could affect how the drug is absorbed, such as inflammatory bowel disease. “Active” means the condition is currently causing symptoms.
  • Having had major surgery or radiation therapy (radiotherapy) too recently before starting the study. “Clinically relevant period” means the time frame that doctors consider important for healing.
  • Being pregnant or breastfeeding.
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Investigated drugs

SOT109 is an experimental medicine being studied for the first time in people with advanced colorectal cancer that cannot be removed by surgery. In this trial, the drug is given directly into a vein through an IV infusion. Researchers are looking at how safe it is, how the body processes it, and whether it can shrink tumors. The study includes steps to find the highest dose that can be given safely and to choose the best dose to use in later trials.

What is already known about the treatment

SOT109 - SOT109 is given by intravenous infusion as a solution that is slowly dripped into a vein. It is a new experimental drug that is being studied for the first time in humans and has not yet been approved for any disease. The drug is being tested for advanced unresectable or metastatic colorectal cancer, a type of colon cancer that cannot be removed by surgery. It works by blocking a specific protein that helps cancer cells grow and spread, placing it in the class of targeted anticancer agents.

Investigated diseases

Advanced unresectable or metastatic colorectal cancer - This is a type of colon or rectum cancer that cannot be removed surgically and has spread to other parts of the body. The disease starts as a tumor in the large intestine and later grows into nearby tissues or travels through the bloodstream to distant organs. As it progresses, the cancer cells continue to multiply and form new tumor sites, often affecting the liver, lungs, or peritoneum. The ongoing spread leads to an increase in tumor burden and related symptoms.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2026-526235-19-00Protocol code109S01Estimated enrolment68 patientsSponsorSOTIO Biotech a.s.

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