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Experimental 'T cell Engager' takes on Hard-to-Treat cancers

NCT ID NCT05359445

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug called IMA401, which helps the body's immune T cells attack cancer cells that have certain markers (MAGE-A4 or MAGE-A8). The study includes about 95 adults with advanced solid tumors that have come back or not responded to other treatments. Some participants will get IMA401 alone, and others will get it combined with the immunotherapy Keytruda, to see if it is safe and shows signs of shrinking tumors.

What this could mean

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

Active substance
IMA401 (a bispecific T cell engaging molecule) and pembrolizumab (Keytruda, a checkpoint inhibitor)
What this could lead to
If this works, it could point toward a new treatment option for certain hard-to-treat solid tumors that express MAGE-A4 or MAGE-A8.
What could go wrong
This is a very early (Phase 1) trial with only 95 participants, so safety and dosing are still being figured out. Many early-stage cancer drugs do not end up working in larger studies.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 95 people

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

Started

May 2022

Expected to finish

Dec 2029

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 must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures * Patients ≥ 18 years old * Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered * Confirmed HLA status and IMA401 tumor target MAGE-A4 and/or MAGE-A8 expression * Life expectancy \> 2 months * ECOG Performance Status of 0 to 1 * Measurable disease according to RECIST 1.1 * Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status * Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy Exclusion Criteria: * Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) * History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab * Patients with prior allogeneic stem cell transplantation or organ transplantation * Patients with autoimmune diseases needing disease-directed treatment * Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results * Positive for HIV or with active hepatitis B or C infection. * Patients with active infection * Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment * Patients with active central nervous system metastases and leptomeningeal metastases

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Conditions

The condition(s) this trial relates to.

cancer head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma 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

Contacts and locations

Locations

  • Charité Universitaetsmedizin Berlin KöR, Klinik fuer Haematologie und Onkologie

    Berlin, 12203, Germany

  • Goethe Universitaetsklinikum Frankfurt AöR, Medizinische Klinik II

    Frankfurt am Main, Hesse, 60590, Germany

  • Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/Haematologie

    Nuremberg, Bavaria, 90419, Germany

  • Klinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin III

    Munich, Bavaria, 81675, Germany

  • Marien Hospital Duesseldorf GmbH, Klinik fuer Onkologie/Haematologie und Palliativmedizin

    Düsseldorf, North Rhine-Westphalia, 40479, Germany

  • Medizinische Hochschule Hannover, Klinik fuer Haematologie, Haemostaseologie, Onkologie und Stammzelltransplantation

    Hanover, Lower Saxony, 30625, Germany

  • Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Universitaet Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)

    Leipzig, Saxony, 04103, Germany

  • Universitaetsklinikum C. - G. - Carus Dresden, Technische Universitaet Dresden AöR, NCT/UCC Early Clinical Trial Unit

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Muenster AöR, Medizinische Klinik A

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3

    Regensburg, Bavaria, 93053, Germany

  • Universitaetsklinikum Schleswig- Holstein, Campus Kiel, Medizinische Klinik II Haematologie und Onkologie, Karl-Lennert Tumorzentrum

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU

    Würzburg, Bavaria, 97078, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, III. Medizinische Klinik

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Universitätsklinikum Bonn AöR, Medizinische Klinik IIII

    Bonn, North Rhine-Westphalia, 53127, Germany

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