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Study of Lurbinectedin and Irinotecan for Patients with Advanced Solid Tumors

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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 combination of two medications, lurbinectedin and irinotecan, in patients who have been previously treated for certain types of advanced cancers known as solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The purpose of the study is to explore how well these medications work together in treating these tumors and to determine the best dose to use.

The study is divided into two phases. In the first phase, researchers aim to find the maximum dose of lurbinectedin that can be safely combined with irinotecan. In the second phase, the focus shifts to understanding how effective this combination is in fighting the cancer. Participants will receive the medications through an intravenous infusion, which means the drugs are delivered directly into the bloodstream through a vein. The study will monitor the participants' response to the treatment and any side effects they may experience.

This trial is open-label, meaning both the researchers and participants know which treatment is being administered. It involves patients with various types of advanced solid tumors, including glioblastoma, soft-tissue sarcoma, endometrial carcinoma, epithelial ovarian carcinoma, mesothelioma, neuroendocrine tumors, small cell lung cancer, pancreatic adenocarcinoma, gastric carcinoma, and colorectal cancer. The study aims to provide valuable information on the potential benefits of using these medications together for treating these challenging conditions.

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 provides a signed and dated informed consent form. This is a document that confirms understanding of the study and agreement to participate.

    The patient must have a confirmed diagnosis of advanced disease in specific tumor types, such as glioblastoma or soft-tissue sarcoma, among others.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure the patient meets all eligibility criteria. This includes adequate bone marrow, liver, and kidney function, as well as a life expectancy of at least three months.

    The patient must have recovered from any side effects of previous treatments to a certain level, except for hair loss, skin issues, nerve damage, or fatigue.

  3. Step 3

    Treatment phase I

    In the phase I escalation stage, the patient receives a combination of lurbinectedin and irinotecan through intravenous administration. The goal is to determine the maximum tolerated dose and the recommended dose.

    The treatment involves a powder that is mixed into a solution for infusion. The specific dosage and frequency are adjusted based on the patient's response and tolerance.

  4. Step 4

    Treatment phase II

    In the phase II expansion stage, the patient continues to receive the combination of lurbinectedin and irinotecan at the recommended dose determined in phase I.

    The focus is on evaluating the effectiveness of the treatment in reducing tumor size or slowing its growth.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, the patient undergoes regular monitoring to assess safety, side effects, and the body's response to the treatment.

    This includes blood tests, imaging studies, and other evaluations as needed to track the progress of the disease and the impact of the treatment.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by January 2026. Upon completion, the patient's overall response to the treatment is evaluated.

    The results contribute to understanding the potential benefits and risks of the treatment combination for future patients with similar conditions.

Who can join the trial?

19 criteria

  • You must sign a written consent form before any study procedures begin.
  • If you are in the Phase II part of the study, your tumor must be measurable according to specific criteria. For glioblastoma patients, additional criteria apply.
  • You need to wait at least 3 weeks after your last cancer treatment before joining the study. This includes treatments like immunotherapy and radiotherapy. For certain drugs, the wait might be longer. Glioblastoma patients have specific waiting periods.
  • Your body must be functioning well enough, which includes:
    • Having enough platelets, a type of blood cell that helps with clotting.
    • Having enough hemoglobin, which carries oxygen in your blood.
    • Having enough neutrophils, a type of white blood cell that fights infection.
    • Having liver enzymes (AST and ALT) within acceptable levels, even if you have liver metastases.
    • Having alkaline phosphatase (ALP) within acceptable levels, especially if you have liver metastases.
    • Having bilirubin levels within acceptable limits, which indicates liver function.
    • Having an INR below 1.5, unless you are on blood thinners.
    • Having a creatinine clearance of at least 30 mL/minute, which shows kidney function.
    • Having creatine phosphokinase (CPK) within acceptable levels.
    • Having albumin levels of at least 3.0 g/dL, which is a protein in your blood.
    • You must have recovered from any side effects of previous treatments to a certain level, except for hair loss, skin issues, nerve damage, or fatigue.
    • You must be at least 18 years old.
    • Your performance status, which measures your ability to carry out daily activities, must be 1 or less on the ECOG scale.
    • You must have a life expectancy of at least 3 months.
    • You must have a confirmed diagnosis of advanced disease in specific types of tumors, such as glioblastoma, soft-tissue sarcoma, endometrial carcinoma, and others.
    • The number of previous treatments you have had is limited, depending on the phase of the study and the type of cancer you have.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with selected advanced solid tumors cannot participate. Advanced solid tumors are types of cancer that form solid masses and have progressed to a more serious stage.
  • Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups.
  • Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate cannot join the study.
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Investigated drugs

  • Lurbinectedin

    is a medication being studied for its potential to treat certain advanced solid tumors. It works by interfering with the DNA of cancer cells, which may help to stop their growth and spread. In this trial, it is being tested in combination with another drug to determine the best dose and to see how effective it is in treating these types of cancers.

  • Irinotecan

    is a chemotherapy drug that is used to treat various types of cancer. It works by inhibiting an enzyme that cancer cells need to divide and grow. In this clinical trial, irinotecan is combined with lurbinectedin to explore whether the combination is more effective in treating advanced solid tumors than using the drugs separately.

What is already known about the treatment

  • Lurbinectedin

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors. It is not yet widely used in standard medical practice, as it is still under investigation. Lurbinectedin works by binding to the DNA in cancer cells, disrupting their ability to replicate and ultimately leading to cell death. It is classified as an antineoplastic agent, specifically a DNA-binding agent.

  • Irinotecan

    This medication is also administered intravenously and is being studied in combination with lurbinectedin for the treatment of advanced solid tumors. Irinotecan is already an established medication in oncology, used primarily for colorectal cancer. It works by inhibiting an enzyme called topoisomerase I, which is necessary for DNA replication in cancer cells, thereby preventing their growth and division. It is classified as a topoisomerase inhibitor.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body. The progression of these tumors can lead to a range of symptoms depending on their location and size. They are often characterized by their ability to resist standard treatments and may require more aggressive therapeutic approaches. Understanding the behavior and progression of these tumors is crucial for developing effective treatment strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515394-10-00Protocol codePM1183-A-014-15Estimated enrolment320 patientsSponsorPharma Mar S.A.

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