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EIK1005 Alone and with Pembrolizumab for Advanced Solid Tumors in Patients with MSI-H or dMMR Tumors

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 being done in people with advanced solid tumors, which are cancers that form a lump or mass in organs or tissues and have grown beyond the original site. The study is testing EIK1005, given as tablets by mouth, alone and together with pembrolizumab, which is given by IV infusion. The purpose of the study is to see whether these treatments are safe and to find a dose of EIK1005 that can be used for further study.

The study has more than one part. In one part, EIK1005 is given by itself. In another part, EIK1005 is given with pembrolizumab. Participants may take the study tablet on a regular schedule and receive pembrolizumab through a vein during clinic visits. During the study, doctors watch for side effects and other health changes, and treatment may be adjusted as needed. The study also includes people with tumors that are MSI-H or dMMR, which are tumor features linked to problems in how cancer cells repair damage in their genetic material.

EIK1005 is also called a Werner helicase inhibitor. A helicase is a protein that helps cells handle and copy genetic material, and this medicine is designed to block that protein. The trial is planned to continue over several years while safety and dose information are collected.

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

    Study treatment begins

    You start the trial by receiving EIK1005 as an oral tablet. The study includes three tablet strengths: 10 mg, 50 mg, and 200 mg.

    In part 1, EIK1005 is given either alone or together with pembrolizumab, which is given by intravenous infusion (through a vein). The purpose of this part is to check the safety and tolerability of the treatment and to find the highest dose that can be given safely, or the highest repeated dose that can be given safely.

    In part 2, EIK1005 is continued for dose optimization, which means the dose is adjusted to help identify a suitable dose for further study. The exact dose, frequency, and duration are not stated in the source data.

  2. Step 2

    Safety checks during treatment

    During the trial, your condition is monitored for adverse events, which means unwanted medical problems or side effects, and for dose-limiting toxicities, which means side effects that may prevent further dose increases.

    These safety checks are used to assess whether the treatment is tolerable and whether dose changes are needed.

  3. Step 3

    Response assessment

    Your tumor response is checked using RECIST 1.1, which is a standard way to measure whether tumors shrink, stay the same, or grow.

    The study looks for complete response (no visible tumor), partial response (tumor shrinkage), stable disease (no major change), and disease progression (the cancer gets worse).

    The trial measures overall response, duration of response, disease control, and progression-free survival, which is the time from randomization until the cancer gets worse or death occurs, whichever happens first.

  4. Step 4

    Blood testing for drug levels

    After multiple doses of EIK1005, blood samples are used to measure how much of the drug is in your body.

    These measurements include AUC0-24, AUCtau,ss, Cmax, t1/2, tmax, Rac-Cmax, and RacAUC. These terms describe drug exposure, the highest drug level, the time it takes to reach that level, how long the drug stays in the body, and how the drug builds up with repeated dosing.

  5. Step 5

    Trial period

    The study is planned to run from 2026-06-01 to 2029-06-01.

    The exact length of your treatment within that period is not stated in the source data.

Who can join the trial?

11 criteria

  • Be 18 years of age or older when signing the informed consent form, which is the document that gives permission to take part in the study.
  • Have a life expectancy of at least 3 months, meaning the study doctor expects the person to live for at least that long.
  • Have a documented advanced solid tumor, meaning a solid cancer confirmed by tissue or cell testing that is unresectable (cannot be removed with surgery) and/or metastatic (has spread to other parts of the body).
  • For Part 1A, have tissue from a past tumor sample that is preferably not more than 3 years old.
  • For Part 1B and Part 2, have a locally confirmed MSI-H or dMMR tumor, and also have stored tumor tissue that is not more than 3 years old so a central laboratory can check this result again. MSI-H means the tumor has a high level of DNA changes, and dMMR means the tumor has a problem repairing DNA damage.
  • For Part 1A, have already received at least 1 standard treatment for advanced cancer and then either the cancer got worse after treatment or the treatment could not be tolerated.
  • For Part 1A, have no other treatment options based on the study doctor’s medical judgment.
  • For Part 1A, preference is given to people with MSI-H or dMMR cancers that got worse after checkpoint inhibitor therapy (a type of treatment that helps the immune system attack cancer), and to people with MSS cancers that got worse after at least one treatment that included platinum, alkylating, or topoisomerase chemotherapy. MSS means the tumor does not have a high level of DNA changes.
  • Have measurable disease at the start of the study, meaning the cancer can be measured on scans or exams using RECIST 1.1, a standard way to measure tumor size.
  • Have an ECOG score of 0 to 1, meaning the person is fully active or only slightly limited in daily activities.
  • Have adequate organ and marrow function, meaning the main organs and the bone marrow, which makes blood cells, are working well enough for the study.

Who cannot join the trial?

11 criteria

  • Not recovered from side effects caused by earlier cancer treatment, meaning the side effects are still worse than mild or have not returned to the person’s usual level.
  • Has received a previous treatment with a WRN inhibitor (a medicine that blocks a protein called WRN).
  • Has a history of relevant drug hypersensitivity, which means a known or suspected allergy to the study drug or its ingredients, a past serious allergic reaction that needed hospital care, or any other allergy that would make the treatment unsafe.
  • For Part 1B: has immunodeficiency (a weak immune system) or is taking systemic steroids in a dose higher than 10 mg of prednisone equivalent per day, or any other immunosuppressive therapy (treatment that lowers the immune system) within 7 days before the first dose of study treatment.
  • Has another active cancer that is getting worse or has needed active treatment within the past 3 years.
  • Has active brain metastases (cancer that has spread to the brain) or carcinomatous meningitis (cancer cells in the lining around the brain or spinal cord). People with brain metastases that were treated before may still qualify only if the scans show no growth for at least 4 weeks, they are medically stable, and they have not needed steroid treatment for at least 14 days before the first study dose.
  • Has a mean resting QTcF above 470 ms on heart tracing tests. QTcF is a heart rhythm measurement on an ECG (electrocardiogram, a test that records the heart’s electrical activity).
  • Has an active autoimmune disease that needed treatment in the past 2 years. Autoimmune disease means the immune system attacks the body’s own tissues. Allowed exceptions are type 1 diabetes, hypothyroidism needing hormone replacement, and certain skin conditions such as vitiligo, psoriasis, or alopecia if they do not need systemic treatment.
  • Has a history of pneumonitis or interstitial lung disease that was not caused by infection and needed steroids, or has this lung condition now. Pneumonitis means inflammation of the lungs, and interstitial lung disease means scarring or inflammation in the lung tissue.
  • Has active tuberculosis, a serious infection that usually affects the lungs.
  • Has any active infection that needs systemic therapy, meaning treatment that works throughout the whole body, such as medicines taken by mouth or given into a vein.
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Investigated drugs

  • EIK1005

    is an experimental tablet taken by mouth. It is being studied as a stand-alone treatment and also together with another cancer medicine. In this trial, researchers want to find out how safe it is, how well people can tolerate it, and what dose may be best to use.

  • Pembrolizumab

    is a cancer medicine given by infusion into a vein. In this study, it is combined with EIK1005 for some participants to see whether the two treatments can work together safely and to help treat advanced solid tumors.

What is already known about the treatment

  • EIK1005 sodium

    EIK1005 sodium is given by mouth as a tablet, swallowed with water. It is an investigational medicine, which means it is still being studied in medical research and is not yet an established treatment in routine care. In this trial, it is being tested for people with advanced solid tumors, alone and together with pembrolizumab, to find a safe dose and learn how well it is tolerated. Its exact way of working is not yet fully public, but as a new cancer drug it is designed to affect signals that help tumor cells grow and survive, and it is classified as an experimental anticancer agent.

  • Pembrolizumab

    Pembrolizumab is given by intravenous infusion, which means it is delivered slowly into a vein by a healthcare professional. It is an approved medicine and is widely described in medical literature as a cancer immunotherapy drug. It is used to treat several cancers, including some advanced solid tumors, and it works by blocking PD-1, a protein that normally helps cancer cells hide from the immune system, allowing immune cells to attack the tumor more strongly. It belongs to the class of immune checkpoint inhibitors, specifically PD-1 inhibitors.

Investigated diseases

Advanced Solid Tumors - Advanced solid tumors are cancerous growths made of abnormal cells that form in organs or tissues other than the blood or bone marrow. They usually begin in one place and then enlarge over time, with some cells spreading into nearby tissue or to other parts of the body. As the disease progresses, the tumor burden may increase and the cancer may become more widespread.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525248-13-00Protocol codeEIK1005-002Estimated enrolment192 patientsSponsorEikon Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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