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Refractory CancerPhase 1NCT05359445

IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

A Phase 1 study testing IMA401 (Phase Ia), Pembrolizumab (Phase Ia) and IMA 401 (Phase Ib) in people with Refractory Cancer and Recurrent Cancer, run by Immatics Biotechnologies GmbH at 21 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMA401 (Phase Ia), Pembrolizumab (Phase Ia) and IMA 401 (Phase Ib)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
21 sitesGermany
Study dates
19 May 2022to Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Germany21 sites

  • Charité Universitaetsmedizin Berlin KöR, Klinik fuer Haematologie und Onkologie

    Berlin, 12203

  • Universitätsklinikum Bonn AöR, Medizinische Klinik IIII

    Bonn, North Rhine-Westphalia, 53127

  • Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III

    Chemnitz, Saxony, 09116

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

    Dresden, Saxony, 01307

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

    Düsseldorf, North Rhine-Westphalia, 40479

  • Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU

    Erlangen, Bavaria, 91054

  • Goethe Universitaetsklinikum Frankfurt AöR, Medizinische Klinik II

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

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

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten

    Heidelberg, Baden-Wurttemberg, 69120

  • Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie

    Heidelberg, Baden-Wurttemberg, 69126

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

    Kiel, Schleswig-Holstein, 24105

  • Universitaet Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)

    Leipzig, Saxony, 04103

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

    Mainz, Rhineland-Palatinate, 55131

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

    Munich, Bavaria, 81675

  • Universitaetsklinikum Muenster AöR, Medizinische Klinik A

    Münster, North Rhine-Westphalia, 48149

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

    Nuremberg, Bavaria, 90419

  • Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3

    Regensburg, Bavaria, 93053

  • Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

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

    Ulm, Baden-Wurttemberg, 89081

  • Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU

    Würzburg, Bavaria, 97078

Other trials in Germany

About this study

Official title: A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), as Monotherapy or in Combination With Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors.

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors.

Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed.

Read more

Primary objective:

  • To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab

Secondary objectives:

  • To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab
  • To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab
  • To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab
Being tested
IMA401 (Phase Ia), Pembrolizumab (Phase Ia), IMA 401 (Phase Ib)
Keywords
MAGE-A4
Medical subject headings
Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMA401 (Phase Ia)Biological

    Intravenous infusions in escalating dose levels

  • Pembrolizumab (Phase Ia)Biological

    Also called Keytruda®

    Intravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab

  • IMA 401 (Phase Ib)Biological

    Treatment at recommended dose for extension (RDE)

Study groups in NCT05359445
Study groupRoleWhat they receive
Dose-Finding IMA401 TCER® Monotherapy (Phase Ia)ExperimentalDose-Finding Escalation/De-escalation with IMA401 TCER® (Phase Ia)
Receives: Biological: IMA401 (Phase Ia)
Dose-Finding Combination Therapy with IMA401 TCER® and Pembrolizumab (Phase Ia)ExperimentalDose-Finding Escalation/De-escalation of combination therapy with IMA401 TCER and pembrolizumab (Phase Ia)
Receives: Biological: IMA401 (Phase Ia); Biological: Pembrolizumab (Phase Ia)
Extension IMA401 TCER® Monotherapy (Phase Ib)ExperimentalIMA401 monotherapy extension cohort following the determination of the recommended dose for extension (RDE) (Phase Ib)
Receives: Biological: IMA 401 (Phase Ib)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with dose limiting toxicities

    Measured: 44 months

Secondary outcomes (19)

  1. Number of patients with treatment-emergent adverse events (TEAEs)

    Measured: 93 months

  2. Number of patients with serious TEAEs

    Measured: 93 months

  3. Number of patients with treatment emergent adverse events of special interest (AESIs)

    Measured: 93 months

  4. Frequency of dose interruptions and reductions

    Measured: 93 months

  5. Duration of dose interruptions and reductions

    Measured: 93 months

  6. Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using RECIST v1.1 and iRECIST

    Measured: 93 months

  7. Disease control rate (DCR) of CR, PR or stable disease (SD) lasting 6 or more weeks following the initiation of IMA401

    Measured: 93 months

  8. Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST

    Measured: 93 months

  9. Progression-free survival (PFS) based on RECIST v1.1 and iRECIST

    Measured: 93 months

  10. Overall survival (OS)

    Measured: 93 months

  11. Determination of IMA 401 PK parameter: maximal serum concentration (Cmax)

    Measured: 44 months

  12. Determination of IMA 401 PK parameter: time at Cmax (Tmax)

    Measured: 44 months

  13. Determination of IMA 401 PK parameter: minimal serum concentration (Cmin)

    Measured: 44 months

  14. Determination of IMA 401 PK parameter: area under the serum concentration-time curve (AUC)

    Measured: 44 months

  15. Determination of IMA 401 PK parameter: clearance (Cl)

    Measured: 44 months

  16. Determination of IMA 401 PK parameter: volume of distribution (Vss)

    Measured: 44 months

  17. Determination of IMA 401 PK parameter: half-life (t1/2)

    Measured: 44 months

  18. Determination of IMA 401 PK parameter: assessment of dose-proportionality

    Measured: 44 months

  19. Determination of IMA 401 PK parameter: steady-state attainment

    Measured: 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start19 May 2022
  3. Primary completion18 Mar 2026
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359445
Sponsor's protocol ID
IMA401-101
Other IDs
2023-506854-19-00, 2023
Status last verified
Apr 2026
First submitted
11 Apr 2022
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Wermke M, Ochsenreither S, Jaeger D, Becker H, Bleckmann A, Bozorgmehr F, Chatterjee M, Groepper S, Haenel M, Hecker JS, Haring MF, Heudobler D, Hilf N, Hofmann M, Hutt M, Mayer-Mokler A, Missel S, Ruh M, Schuster H, Veremchuk O, Kleemiss M, Knop S, Laban S, Sebastian M, Spoerl S, Britten CM, Reinhardt C. MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial. Nat Med. 2026 May 31. doi: 10.1038/s41591-026-04455-x. Online ahead of print.

    PubMed 42219399

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMA401 (Phase Ia), Pembrolizumab (Phase Ia) and IMA 401 (Phase Ib) in people with Refractory Cancer and Recurrent Cancer, run by Immatics Biotechnologies GmbH at 21 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with dose limiting toxicities (time frame: 44 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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