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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Marien Hospital Duesseldorf GmbH Duesseldorf Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Philipps-Universitaet Marburg Marburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Universitaetsklinikum Ulm AöR Ulm Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Netherlands Cancer Institute Amsterdam The Netherlands
Johannes Wesling Klinikum Minden Minden Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Sana Klinikum Offenbach GmbH Offenbach Am Main Germany
Lwkvy Ujkvuhdquuqx Mklnmij Cteotnu (hzhxn Leiden The Netherlands
Ukfsnfrqujle Msfaoia Cmskiyj Ggkkeeggt Groningen The Netherlands
Urwweroakdjwsfklvopew Mrcuiqus Ase Munster Germany
Uwqabtiepjclkzbwbmgfp Wkljjmfeg Agl Wuerzburg Germany
Uuwlwicafuqeshvoqpkrx Ebpnd Aiu Essen Germany
Kwbepemz Engumhxycjecftmpfrbhegsw Hekenwxnfzhswyutp Essen Germany
Ghfbts Uvlefcohmk Fvsdexgyv Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
31.08.2023
The Netherlands The Netherlands
Recruiting
31.08.2023

Trial locations

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.

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.

Trial ID:
2022-503133-54-00
Protocol code:
IMA402-101
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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