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Study on the Safety and Effectiveness of IMA402, Tocilizumab, and Human Serum Albumin for Patients with Recurrent or Resistant 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 new treatment called IMA402 on patients with solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The treatment being tested, IMA402, is a special type of protein known as a bispecific T cell receptor-antibody fusion protein, which is designed to help the body's immune system target and fight cancer cells more effectively. The trial will also involve the use of Human Serum Albumin and Tocilizumab, which are solutions given through an intravenous infusion, meaning they are administered directly into the bloodstream.

The purpose of this study is to evaluate the safety, tolerability, and anti-tumor activity of IMA402 in patients whose solid tumors have returned or are resistant to standard treatments. The study will be conducted in two phases. In the first phase, researchers will determine the most appropriate dose of IMA402 that patients can tolerate. In the second phase, the focus will be on assessing how well the treatment works in reducing the size of the tumors.

Participants in the study will receive the treatment through an intravenous infusion, and their health will be closely monitored by the research team. The study aims to gather information on any side effects experienced by the participants and how the treatment affects their tumors. This information will help researchers understand the potential benefits and risks of IMA402 for treating solid tumors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the clinical trial, an initial assessment will be conducted to confirm eligibility. This includes verifying that you are at least 18 years old, have a confirmed diagnosis of advanced or metastatic solid tumors with specific target expression, and meet other health criteria.
Your health status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) Performance Status, which measures your ability to perform daily activities.
Step 2
Treatment phase i
In Phase I, the focus is on determining the maximum tolerated dose of the medication IMA402. This involves receiving the medication through an intravenous infusion, which means it will be administered directly into your bloodstream.
The frequency and dosage will be adjusted based on your response and any side effects experienced. The goal is to find a safe and effective dose.
Step 3
Monitoring and evaluation
Throughout the trial, regular monitoring will occur to assess your health and any side effects. This includes checking for dose-limiting toxicities and treatment-emergent adverse events.
Your response to the treatment will be evaluated using criteria that measure changes in tumor size and progression.
Step 4
Treatment phase ii
In Phase II, the focus shifts to evaluating the anti-tumor activity of IMA402. The dosage determined in Phase I will be used to assess its effectiveness in reducing tumor size or slowing progression.
Regular assessments will continue to monitor your response and any side effects.
Step 5
Completion and follow-up
Upon completion of the treatment phases, a final evaluation will be conducted to assess overall outcomes and any long-term effects.
Follow-up visits may be scheduled to monitor your health and gather additional data on the treatment's impact.

Who can join the trial?

7 criteria

Patients must be 18 years old or older.
Must have a confirmed diagnosis of advanced or metastatic solid tumors with a specific tumor target expression called PRAME.
Must have a confirmed HLA status. HLA refers to a group of genes that help the immune system recognize the body's own proteins versus proteins made by foreign invaders.
Must have a measurable disease according to specific criteria used to evaluate tumors, known as RECIST 1.1.
Must have an ECOG Performance Status of 0 to 1. This is a scale used to assess how a patient's disease is progressing, including their level of functioning and ability to care for themselves.
Must have received or not be eligible for all available standard treatments that are typically used for their condition.
Must have adequate baseline function of blood, kidneys, and liver, and acceptable blood clotting status.

Who cannot join the trial?

4 criteria

Patients with certain types of **solid tumors** cannot participate. Solid tumors are abnormal masses of tissue that usually do not contain liquid areas.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the safety and health requirements set by the study cannot participate. This is to ensure the safety of all participants.

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Verified sites

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
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Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
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Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

Trial locations

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Investigated drugs

IMA402 is a special type of treatment designed to help the body's immune system fight cancer. It works by connecting two important parts of the immune system: T cells, which are like the body's soldiers, and a specific target found on some cancer cells called PRAME. By bringing these two together, IMA402 helps the T cells find and attack the cancer cells more effectively. This treatment is being tested to see how safe it is for patients and how well it can help reduce or eliminate tumors in people with certain types of cancer that have come back or are not responding to other treatments.

What is already known about the treatment

IMA402 – IMA402 is administered as an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials to assess its safety, tolerability, and effectiveness against solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. The medication works by engaging T cells, a type of immune cell, to target and attack cancer cells expressing a protein called PRAME. IMA402 is classified as a bispecific T cell-engaging receptor molecule, which is a type of immunotherapy designed to help the body's immune system fight cancer.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially causing physical obstruction or functional impairment. The growth rate and behavior of solid tumors can vary widely, with some growing slowly and others rapidly. They can be benign, meaning non-cancerous, or malignant, which indicates cancerous growth.