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RecruitingPHASE1, PHASE2INTERVENTIONAL

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

This research study is investigating a new treatment called IMA402 for adults who have solid cancers that have come back or are no longer responding to standard treatments. Solid tumours are cancers that form a lump, unlike blood cancers. The main goals are to check how safe IMA402 is, find the best dose, and see if it can help reduce the size of the tumours. The study involves different stages (Phase 1 and Phase 2), gradually increasing the number of people taking part and gathering more information. We are looking for people who are aged 18 or over and have certain types of cancer and overall good health, to help us understand if this new medicine could be a future treatment option.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Immatics Biotechnologies GmbH
Enrolment target
145
Start
09 Aug 2023
Estimated completion
01 Sep 2027

What is this study about?

This study is about a new investigational medicine called IMA402. 'Investigational' means it's still being researched and is not yet available as a standard treatment. We're looking at its effects in adults who have a type of cancer known as a 'solid tumour'. This means your cancer forms a lump or mass, rather than being in your blood. Participants in this study will have cancer that has either come back after treatment ('recurrent') or hasn't responded to other treatments ('refractory').

The main aim of the study is to see if IMA402 is safe to use and to find out what dose works best without causing too many side effects. We also want to understand if this medicine can help to shrink tumours or stop them from growing. This is important because it could offer a new option for people whose cancer hasn't responded to existing treatments. The study will happen in different stages, starting with a small number of people to check safety, then expanding to more people to gather more information about its effects.

Researchers will be carefully monitoring participants throughout the study. They'll regularly check for any side effects and measure how the cancer is responding to the treatment. This will help them understand how IMA402 works in the body and if it could be a helpful treatment for solid tumours in the future.

Key takeaways

  • New medicine (IMA402) for advanced or returning solid cancers.
  • Aims to check safety, find best dose, and see if it shrinks tumours.
  • For adults (18+) whose cancer hasn't responded to other treatments.
  • Requires regular hospital visits, blood tests, and scans.
  • Potential benefits include tumour control; risks include unknown side effects.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older. You would need to have a confirmed diagnosis of a solid cancer that is advanced (meaning it has spread) or has returned, and it must be a type that hasn't responded to, or can't be treated with, the usual care options available.

To be considered, your overall health should be good enough to take part in the study, and doctors will look at specific blood tests to make sure your kidneys, liver, and other body systems are working well. You must also have measurable cancer, meaning the doctors can clearly see and measure the tumour.

There are also some reasons why you might not be able to join. For example, if you have other active cancers that need treatment, are pregnant or breastfeeding, or have certain severe medical conditions that could make the study unsafe for you. People with active cancer that has spread to the brain would also not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a solid cancer that has returned or is no longer responding to usual treatments?
  3. Does your doctor confirm that your cancer can be measured (e.g., seen on a scan)?
  4. Are you able to attend regular hospital appointments for check-ups and tests?
  5. Are you not currently pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, IMA402. The first part of the study (Phase 1) will be about finding the safest and most effective dose. This might involve starting with a low dose and slowly increasing it, or possibly decreasing it if needed. Once the best dose is found, more people will join in later parts of the study (Phase 2) to see how well it works against different types of cancer.

Throughout the study, you'll have regular hospital visits. These visits will include check-ups, physical examinations, blood tests, and scans (like CT or MRI scans) to monitor your health and see how the cancer is responding to the treatment. You'll also be asked about any side effects you might be experiencing. The exact number and frequency of visits will depend on which stage of the study you are in, but it will involve ongoing monitoring for a period, with follow-up appointments even after you stop taking the study medicine.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The potential benefit of this study is that IMA402 could help reduce or control your cancer, especially if other treatments haven't worked for you. However, as this is a new medicine, there might be side effects that are not yet fully known. The research team will monitor you closely for any reactions. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (24)

  • Universitaetsklinikum Heidelberg AöR
    Verified postcode
    Heidelberg, Germany· Recruiting
  • Universitaetsklinikum Mannheim GmbH
    Verified postcode
    Mannheim, Germany· Recruiting
  • Universitaetsklinikum Ulm AöR
    Verified postcode
    Ulm, Germany· Recruiting
  • Universitaetsklinikum Erlangen AöR
    Verified postcode
    Erlangen, Germany· Recruiting
  • Klinikum Nürnberg
    Verified postcode
    Nuremberg, Germany· Recruiting
  • Universitaetsklinikum Regensburg
    Verified postcode
    Regensburg, Germany· Recruiting
  • Universitaetsklinikum Wuerzburg AöR
    Verified postcode
    Würzburg, Germany· Recruiting
  • Justus-Liebig-Universitaet Giessen
    Verified postcode
    Giessen, Germany· Recruiting
  • Philipps-Universitaet Marburg
    Verified postcode
    Marburg, Germany· Recruiting
  • Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
    Verified postcode
    Buxtehude, Germany· Recruiting
  • Universitaetsklinikum Bonn AöR
    Verified postcode
    Bonn, Germany· Recruiting
  • Marien Hospital Duesseldorf GmbH
    Verified postcode
    Düsseldorf, Germany· Recruiting

Common questions

What is a 'solid tumour'?

A solid tumour is a cancer that forms a lump or mass of tissue, unlike blood cancers like leukaemia.

What does 'recurrent and/or refractory' mean?

'Recurrent' means the cancer has come back after treatment. 'Refractory' means the cancer hasn't responded to other treatments, or has stopped responding.

What is a 'clinical trial phase'?

Clinical trials happen in phases. Phase 1 focuses on safety and finding the right dose. Phase 2 looks at how well the treatment works and continues to monitor safety.

Will I definitely get the new medicine?

Yes, in this study, all participants who meet the criteria will receive the investigational medicine, IMA402. There isn't a placebo group.

What does 'TCER®' mean?

TCER® is a type of treatment that helps your own immune system (T-cells) recognise and fight cancer cells more effectively.

How to find out more

Immatics Biotechnologies GmbH

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurren…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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