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Study of ICT01 and Pembrolizumab for Patients with Advanced-Stage, Relapsed/Refractory Cancer

Fast replyRegistered 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 the effects of a new treatment for patients with advanced-stage, relapsed/refractory cancer. The study involves a medication called ICT01, which is being tested both on its own and in combination with another drug known as pembrolizumab (also called Keytruda). The trial aims to understand how safe and tolerable these treatments are for patients, as well as their potential effectiveness in fighting cancer.

The study is divided into two parts. In the first part, patients with various types of advanced solid tumors or blood cancers will receive ICT01 either alone or together with pembrolizumab. The second part will explore the effects of ICT01 in combination with pembrolizumab for solid tumors and with other medications like venetoclax (known as Venclyxto or Venclexta) and azacitidine (known as Vidaza) for patients newly diagnosed with acute myeloid leukemia (AML).

Throughout the study, patients will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The trial will monitor the patients for any side effects and assess how the cancer responds to the treatment. The goal is to gather information that could lead to new treatment options for people with these challenging types of cancer.

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

    Joining the study

    Upon joining the study, the patient will receive a detailed explanation of the trial's purpose and procedures. Consent is required before any study-related activities begin.

  2. Step 2

    Initial assessment

    The patient will undergo a series of initial assessments, including medical history review, physical examination, and laboratory tests to confirm eligibility for the study.

  3. Step 3

    Treatment phase 1

    The patient will receive ICT01 as a monotherapy through an intravenous infusion. The dosage and frequency will be determined based on the patient's specific condition and response to treatment.

    Regular monitoring will occur to assess the patient's response and any potential side effects.

  4. Step 4

    Combination treatment

    If applicable, the patient may receive a combination of ICT01 and pembrolizumab (Keytruda®) through intravenous infusion. This phase aims to evaluate the combined effect of these medications.

    The frequency and dosage will be adjusted according to the patient's response and tolerance.

  5. Step 5

    Ongoing assessments

    Throughout the trial, the patient will undergo regular assessments, including physical exams, laboratory tests, and imaging studies, to monitor the effectiveness of the treatment and any side effects.

    Adjustments to the treatment plan may be made based on these assessments.

  6. Step 6

    End of treatment

    Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall response to the treatment.

    The patient will receive guidance on post-trial care and any necessary follow-up appointments.

Who can join the trial?

12 criteria

  • Must be a male or female aged 18 years or older.
  • Must voluntarily sign a written informed consent before any study-related procedures.
  • Must have a confirmed diagnosis of advanced cancer, which includes various types such as bladder, breast, colorectal, gastric, ovarian, prostate cancer, melanoma, and others.
  • Must be willing to undergo necessary medical tests and procedures during the study.
  • Must have a life expectancy of more than 3 months, as assessed by the doctor.
  • Must have certain levels of blood and liver function tests within specified limits.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control methods during the study and for a specified period after the study.
  • Men must agree to use a condom and not donate sperm during the study and for a specified period after the study.
  • Women must not be breastfeeding during the study.
  • Must have at least one measurable tumor or a certain percentage of cancer cells in the bone marrow.
  • Must not have any standard treatment options available that could provide a survival benefit, as determined by the doctor.
  • Must meet specific conditions related to previous treatments and health status, depending on the type of cancer and treatment group.

Who cannot join the trial?

10 criteria

  • Patients who have a type of cancer that is not in an advanced stage or has not come back after treatment.
  • Patients who have not tried other treatments for their cancer and found them ineffective.
  • Patients who are not adults, as the study is for adults only.
  • Patients who are not able to give their own consent to participate in the study.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are recovering from one.
  • Patients who have an active infection that requires treatment.
  • Patients who have a known allergy to any of the study medications.
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Investigated drugs

  • ICT01

    is an experimental medication being tested for its safety and effectiveness in treating advanced-stage cancers. It is administered through an intravenous (IV) infusion. The study aims to understand how well patients tolerate this medication when used alone and how it might help in fighting cancer.

  • Pembrolizumab

    (Keytruda®) is an immune checkpoint inhibitor used in this study in combination with ICT01. It works by helping the immune system recognize and attack cancer cells more effectively. This combination is being tested to see if it improves treatment outcomes for patients with advanced solid tumors or blood cancers.

  • Venetoclax

    (Venclyxto®, Venclexta®) is a medication used in this study for patients with newly diagnosed acute myeloid leukemia (AML). It helps to kill cancer cells by targeting a specific protein that allows them to survive. In this trial, it is combined with ICT01 to evaluate its effectiveness in treating AML.

  • Azacitidine

    (Vidaza®) is another medication used in combination with ICT01 for patients with newly diagnosed AML. It works by interfering with the growth of cancer cells, and the study is assessing whether this combination can improve treatment outcomes for these patients.

What is already known about the treatment

ICT01 – This medication is administered intravenously and is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating advanced-stage, relapsed, or refractory cancer. It is being tested both as a standalone treatment and in combination with other drugs like pembrolizumab. ICT01 is primarily indicated for patients with advanced solid tumors or hematologic malignancies. At the molecular level, it works by targeting specific immune cells to enhance the body's immune response against cancer cells. It falls under the pharmacological classification of immunotherapy agents.

Investigated diseases

Advanced-stage, relapsed/refractory cancer – This term refers to cancers that have progressed to an advanced stage and have either returned after treatment or are resistant to standard therapies. These cancers can be solid tumors or hematologic malignancies, meaning they can affect organs or blood-forming tissues. The disease is characterized by the uncontrolled growth and spread of abnormal cells, which can invade nearby tissues and potentially spread to other parts of the body. As the cancer progresses, it may cause a variety of symptoms depending on the location and type of cancer. The progression of the disease can lead to significant changes in the body's normal functions.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515560-30-00Protocol codeICT01-101Estimated enrolment375 patientsSponsorImcheck Therapeutics

sourced from the EU Clinical Trials Register and site verification

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