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New drug IMA402 targets tough cancers in early trial

NCT ID NCT05958121

Disease control Sponsor: Immatics Biotechnologies GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study tests a new drug called IMA402 in people with advanced solid tumors that have come back or not responded to treatment. IMA402 is designed to help the immune system attack cancer cells. The trial will check if the drug is safe and whether it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMA402 (a bispecific TCER molecule targeting PRAME)
What this could lead to
If successful, this could lead to a new treatment option for patients with hard-to-treat solid tumors that have not responded to standard therapies.
What could go wrong
This is an early first-in-human trial, so safety and effectiveness are not yet known. The treatment may cause side effects or fail to shrink tumors.
Why investors are watching

Immatics is testing IMA402, a drug that aims to direct the immune system to attack tumors that carry a protein called PRAME, in patients with advanced solid tumors that have stopped responding to other treatments. The trial is a first-in-human study, so the main questions are whether the drug is safe and whether it shrinks tumors, both on its own and with a second drug called pembrolizumab. For a small company like Immatics, this readout matters because IMA402 is one of its key pipeline assets, and the results will show whether the drug has enough promise to continue development.

If it works: If the trial shows IMA402 is safe and produces clear anti-tumor activity, Immatics could advance the drug into later-stage testing and potentially attract a partnership with a larger pharmaceutical company. A positive result would validate the company's technology platform and support its value as a developer of cancer immunotherapies.

If it fails: First-in-human trials often fail because the drug proves too toxic or shows little benefit, and this one is no exception. A poor safety profile or weak tumor response could force Immatics to abandon IMA402, which would be a major setback for a small company with a limited number of pipeline candidates.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients ≥ 18 years old * Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication * Patients must have received or not be eligible for indicated standard-of-care treatments per cohort * Measurable disease according to RECIST 1.1 * Confirmed HLA status * ECOG Performance Status of 0 to 1 * Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status Exclusion Criteria: * Other active malignancies that require treatment or that might interfere with the trial endpoints * The patient is pregnant or is breastfeeding * History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product * The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures * Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation

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Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm neoplasm Recurrence refractory malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Recurrent cancer Refractory cancer Solid tumor, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    27 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Antoni von Leeuwenhoek- Netherlands Cancer Institute

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH

    RECRUITING

    Buxtehude, Lower Saxony, 21614, Germany

  • Goethe University Frankfurt

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Johannes Wesling Klinikum Minden

    RECRUITING

    Minden, North Rhine-Westphalia, 32429, Germany

  • Justus-Liebig-Universitaet Giessen

    RECRUITING

    Giessen, Hesse, 35392, Germany

  • KEM I Evang. Kliniken Essen-Mitte gGmbH

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Klinikum Chemnitz gGmbH

    COMPLETED

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Nürnberg

    COMPLETED

    Nuremberg, Bavaria, 90419, Germany

  • Leiden Universitair Medisch Centrum

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Marien Hospital Duesseldorf GmbH

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40479, Germany

  • Philipps-Universitaet Marburg

    RECRUITING

    Marburg, Hesse, 35043, Germany

  • Sana Klinikum Offenbach GmbH

    NOT_YET_RECRUITING

    Offenbach, Hesse, 63069, Germany

  • Thoraxklinik Heidelberg gGmbH

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Universitaet Muenster

    NOT_YET_RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitaetsklinikum Bonn AöR

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Erlangen AöR

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Essen AöR

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitaetsklinikum Heidelberg AöR

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Magdeburg AöR

    RECRUITING

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Universitaetsklinikum Mannheim GmbH

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Universitaetsklinikum Regensburg

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • Universitaetsklinikum Tuebingen AöR

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Ulm AöR

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitaetsklinikum Wuerzburg AöR

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitaetsmedizin Goettingen

    NOT_YET_RECRUITING

    Göttingen, Lower Saxony, 37075, Germany

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • University Of Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

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