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Study on the Safety and Effects of ICT01, Aldesleukin, and Pembrolizumab for Patients with Advanced Solid Tumors

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

This clinical trial is focused on studying advanced forms of cancer, specifically metastatic colorectal cancer, metastatic or unresectable refractory melanoma, metastatic castration-resistant prostate cancer, metastatic ovarian cancer, and metastatic pancreatic ductal adenocarcinoma. The study is testing a combination of treatments to see how safe and effective they are. The treatments being tested include a new medication called ICT01, which is given through an intravenous infusion, and a low-dose of interleukin-2, which is administered subcutaneously, meaning it is injected under the skin. In some cases, the study also includes the use of pembrolizumab, a medication that is already used to treat certain types of cancer.

The purpose of the study is to assess the safety and potential benefits of these treatments in patients with advanced solid tumors. The study is divided into two parts. In the first part, researchers will focus on understanding how safe and tolerable the combination of ICT01 and low-dose interleukin-2 is, both with and without pembrolizumab. In the second part, the study will look at how well these treatments work in controlling the cancer. Patients will receive the treatments and be monitored for any side effects and changes in their cancer status.

Participants in the study will receive the treatments over a period of time and will have regular check-ups to monitor their health and the progress of their cancer. The study aims to gather information on how the cancer responds to the treatments and any side effects that may occur. This information will help determine if these treatment combinations could be beneficial for patients with these types of advanced cancers in the future.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. Consent is required before any study-related activities begin.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests.

  3. Step 3

    Treatment phase part I

    The patient will receive ICT01 through an intravenous (IV) infusion. The dosage will be determined based on safety and tolerability assessments.

    In combination, a low-dose of interleukin-2 (IL-2) will be administered subcutaneously (under the skin).

    For patients with advanced melanoma or pancreatic ductal adenocarcinoma, pembrolizumab will also be administered intravenously.

  4. Step 4

    Monitoring and evaluation part I

    The patient will be monitored for any side effects or adverse reactions. Regular check-ups will include physical exams, blood tests, and imaging studies.

    The primary focus is on safety and tolerability, with adjustments made to the treatment as necessary.

  5. Step 5

    Treatment phase part II

    Based on results from Part I, the patient may continue to receive ICT01 and interleukin-2, with or without pembrolizumab, depending on the specific tumor type.

    The aim is to assess the preliminary anti-tumor activity.

  6. Step 6

    Monitoring and evaluation part II

    The patient will continue to be monitored for disease control, which includes stable disease, partial response, or complete response.

    Safety and tolerability will remain a key focus, with regular assessments similar to Part I.

  7. Step 7

    End of study

    The study is estimated to conclude by March 2025. Final assessments will be conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

24 criteria

  • Must be a male or female aged 18 years or older.
  • Must have voluntarily signed a written informed consent before any study-related screening procedures.
  • Must be a patient whose cancer has returned or not responded to treatment and has failed at least two lines of systemic therapy, or failed the first line of therapy and cannot tolerate or has a contraindication to the standard second line of therapy.
  • Must have a confirmed diagnosis of one of the following:
    • Metastatic colorectal cancer (mCRC): Cancer that has spread from the colon or rectum to other parts of the body. Patients must have progressed after receiving specific treatments and, if applicable, prior therapy with a checkpoint inhibitor.
    • Metastatic ovarian cancer: Cancer that has spread from the ovaries to other parts of the body. Patients must be resistant to platinum-based chemotherapy and have had at least one treatment line after becoming resistant.
    • Metastatic castration-resistant prostate cancer (mCRPC): Prostate cancer that continues to grow despite hormone therapy.
    • Metastatic pancreatic ductal adenocarcinoma (PDAC): Cancer that has spread from the pancreas to other parts of the body.
    • Metastatic or unresectable refractory melanoma: Skin cancer that has spread or cannot be removed by surgery and has not responded to at least six weeks of prior treatment.
    • Must have no available standard of care or treatment with potential survival benefit for their disease, as determined by the treating doctor.
    • Must have a baseline tumor biopsy available and be willing to undergo additional tumor biopsies during the study.
    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
    • Must have a life expectancy of more than 3 months, as assessed by the doctor.
    • Must meet specific clinical laboratory assessment criteria, including:
      • Hemoglobin level of at least 8.5 g/dL.
      • Platelet count of at least 100 x 109/L.
      • Lymphocyte count of at least 0.5 x 109/L.
      • Absolute neutrophil count of at least 1.0 x 109/L.
      • White blood cell count of at least 4 x 109/L.
      • Liver enzymes (AST and ALT) within 2.5 times the upper limit of normal, or less than 5 times if there are liver metastases.
      • Bilirubin level within 1.5 times the upper limit of normal, or less than 2 times if there are liver metastases.
      • Serum creatinine level less than 1.5 times the upper limit of normal, or creatinine clearance of at least 50 mL/min.
      • Must have a pulse oximetry reading of 95% or higher at rest, unless the patient has chronic lung disease, in which case 90% or higher is acceptable.
      • Must agree to use contraceptive measures.
      • Women must not be breastfeeding.
      • Must have at least one measurable lesion as per RECIST, which is a set of guidelines to measure how well a cancer treatment is working.

Who cannot join the trial?

8 criteria

  • Patients who have a type of cancer that has spread to other parts of the body, such as **metastatic colorectal cancer**.
  • Patients with **metastatic or unresectable refractory melanoma**, which means the melanoma has spread and cannot be removed by surgery.
  • Patients with **metastatic castration-resistant prostate cancer**, a type of prostate cancer that continues to grow even when the amount of male hormones is reduced to very low levels.
  • Patients with **metastatic ovarian cancer**, where the cancer has spread beyond the ovaries.
  • Patients with **metastatic pancreatic ductal adenocarcinoma**, a type of pancreatic cancer that has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • ICT01

    is an experimental medication being tested for its safety and effectiveness in treating advanced solid tumors. It is administered through an intravenous (IV) infusion, meaning it is given directly into the bloodstream. The study aims to understand how well patients tolerate this medication and its potential to reduce tumor size.

  • Interleukin-2 (IL-2)

    is a medication used in this study at a low dose and given as a subcutaneous injection, which means it is injected under the skin. IL-2 is a type of protein that can help boost the immune system to fight cancer cells. In this trial, it is combined with ICT01 to see if the combination can improve treatment outcomes for patients with advanced solid tumors.

  • Pembrolizumab

    is a medication used in some parts of the study for patients with advanced melanoma or pancreatic ductal adenocarcinoma (PDAC). It is an immunotherapy drug that helps the immune system recognize and attack cancer cells. The study is exploring how well pembrolizumab works when used together with ICT01 and IL-2.

What is already known about the treatment

ICT01 – ICT01 is administered intravenously and is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating advanced solid tumors, including metastatic colorectal cancer, melanoma, prostate cancer, ovarian cancer, and pancreatic cancer. It is often used in combination with low-dose subcutaneous interleukin-2 and sometimes with pembrolizumab. ICT01 works by targeting specific immune cells to enhance the body's immune response against cancer cells. It is classified as an immunotherapy agent, focusing on activating the immune system to fight cancer.

Investigated diseases

  • Metastatic Colorectal Cancer

    This is a type of cancer that begins in the colon or rectum and spreads to other parts of the body. It often progresses by invading nearby tissues and can spread to distant organs such as the liver or lungs. The disease may cause symptoms like changes in bowel habits, abdominal pain, and weight loss. As it advances, it can lead to more severe complications depending on the organs affected.

  • Metastatic Melanoma

    This is an advanced form of skin cancer that has spread from its original site to other parts of the body. It typically progresses by invading nearby lymph nodes and can spread to distant organs such as the lungs, liver, or brain. Symptoms may include new or changing moles, skin lesions, and swollen lymph nodes. As the disease advances, it can cause more systemic symptoms and complications.

  • Metastatic Castration-Resistant Prostate Cancer

    This is a type of prostate cancer that continues to grow and spread despite low levels of testosterone. It often progresses by spreading to bones and other organs, causing symptoms like bone pain and urinary issues. The disease can lead to more severe complications as it advances, affecting overall health and quality of life.

  • Metastatic Ovarian Cancer

    This is an advanced stage of ovarian cancer where the cancer cells have spread beyond the ovaries. It typically progresses by spreading to the abdominal lining and other organs within the abdomen. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. As the disease advances, it can lead to more severe symptoms and complications.

  • Metastatic Pancreatic Ductal Adenocarcinoma

    This is a type of pancreatic cancer that has spread beyond the pancreas to other parts of the body. It often progresses by invading nearby tissues and can spread to distant organs such as the liver and lungs. Symptoms may include jaundice, weight loss, and abdominal pain. As the disease advances, it can cause more severe complications and affect overall health.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-514758-65-00Protocol codeEVICTION-2Estimated enrolment88 patientsSponsorImcheck Therapeutics

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