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Refractory CancerPhase 1/2NCT05958121

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

A Phase 1/2 study testing IMA402, IMA402 and checkpoint inhibitor and IMA402 and chemotherapy in people with Refractory Cancer and Recurrent Cancer, run by Immatics Biotechnologies GmbH at 29 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors. Primary objectives: To determine the maximum tolerated doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMA402, IMA402 and checkpoint inhibitor and IMA402 and chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
29 sitesin 2 countries
Study dates
9 Aug 2023to Sep 2027
Phase
Phase 1/2
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 ≥ 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

Who cannot join

  • 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

Trial locations and contacts

29 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Immatics Biotechnologies GmbH contact

Please E-Mail

Ctgovinquiries@immatics.com

29 sites in 2 countries

Germany25 sites, 23 recruiting

  • Universitaetsklinikum Bonn AöR

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

  • Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH

    Buxtehude, Lower Saxony, 21614

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

    Completed

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

    Dresden, Saxony, 01307

    Recruiting

  • Marien Hospital Duesseldorf GmbH

    Düsseldorf, North Rhine-Westphalia, 40479

    Recruiting

  • Universitaetsklinikum Erlangen AöR

    Erlangen, Bavaria, 91054

    Recruiting

  • KEM I Evang. Kliniken Essen-Mitte gGmbH

    Essen, North Rhine-Westphalia, 45136

    Recruiting

  • Universitaetsklinikum Essen AöR

    Essen, North Rhine-Westphalia, 45147

    Recruiting

  • Goethe University Frankfurt

    Frankfurt am Main, Hesse, 60590

    Recruiting

  • Justus-Liebig-Universitaet Giessen

    Giessen, Hesse, 35392

    Recruiting

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075

    Not yet recruiting

  • Universitaetsklinikum Heidelberg AöR

    Heidelberg, Baden-Wurttemberg, 69120

    Recruiting

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126

    Recruiting

  • University Of Leipzig

    Leipzig, Saxony, 04103

    Recruiting

  • Universitaetsklinikum Magdeburg AöR

    Magdeburg, Saxony-Anhalt, 39120

    Recruiting

  • Universitaetsklinikum Mannheim GmbH

    Mannheim, Baden-Wurttemberg, 68167

    Recruiting

  • Philipps-Universitaet Marburg

    Marburg, Hesse, 35043

    Recruiting

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429

    Recruiting

  • Universitaet Muenster

    Münster, North Rhine-Westphalia, 48149

    Not yet recruiting

  • Klinikum Nürnberg

    Nuremberg, Bavaria, 90419

    Completed

  • Sana Klinikum Offenbach GmbH

    Offenbach, Hesse, 63069

    Not yet recruiting

  • Universitaetsklinikum Regensburg

    Regensburg, Bavaria, 93053

    Recruiting

  • Universitaetsklinikum Tuebingen AöR

    Tübingen, Baden-Wurttemberg, 72076

    Recruiting

  • Universitaetsklinikum Ulm AöR

    Ulm, Baden-Wurttemberg, 89081

    Recruiting

  • Universitaetsklinikum Wuerzburg AöR

    Würzburg, Bavaria, 97080

    Recruiting

Other trials in Germany

Netherlands4 sites, 4 recruiting

  • Antoni von Leeuwenhoek- Netherlands Cancer Institute

    Amsterdam, North Holland, 1066 CX

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Recruiting

  • Leiden Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA

    Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

About this study

Official title: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors.

Primary objectives:

Read more
  • To determine the maximum tolerated doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)
  • To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II)
  • To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)

Secondary objectives:

  • To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I)
  • To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)
  • To describe the PK of IMA402 as monotherapy and in combination (Phase I/II)
Read the detailed description

The study will be conducted in two phases:

  • Phase Ia: Dose escalation/de-escalation
  • Phase Ib: Dose extension
  • Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)
Being tested
IMA402, IMA402 and checkpoint inhibitor, IMA402 and chemotherapy, IMA402 and IMA401, IMA402 and monoclonal antibody
Medical subject headings
Neoplasms, Recurrence

What participants receive

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

  • IMA402Drug

    IV infusions

  • IMA402 and checkpoint inhibitorDrug

    IMA402 IV infusions and checkpoint inhibitor

  • IMA402 and chemotherapyDrug

    IMA402 IV infusions and chemotherapy

  • IMA402 and IMA401Drug

    IMA402 and IMA401 IV infusions

  • IMA402 and monoclonal antibodyDrug

    IMA402 IV infusions and monoclonal antibody

  • IMA402 and chemotherapy +/- monoclonal antibodyDrug

    IMA402 IV infusions and chemotherapy +/- monoclonal antibody

Study groups in NCT05958121
Study groupRoleWhat they receive
Dose escalation/de-escalation (Phase Ia)ExperimentalDose-Finding of IMA402 as monotherapy or in combination with checkpoint inhibitor (Phase Ia)
Receives: Drug: IMA402; Drug: IMA402 and checkpoint inhibitor
Dose extension (Phase Ib)ExperimentalExtension cohorts of IMA402 as monotherapy or in combination based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
Receives: Drug: IMA402; Drug: IMA402 and checkpoint inhibitor; Drug: IMA402 and chemotherapy; Drug: IMA402 and IMA401; Drug: IMA402 and monoclonal antibody; Drug: IMA402 and chemotherapy +/- monoclonal antibody
Dose extension (Phase II)ExperimentalSelected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)
Receives: Drug: IMA402; Drug: IMA402 and checkpoint inhibitor

What is being measured

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

  1. Phase I: Number of patients with dose limiting toxicities (DLTs)

    Measured: 24 months

  2. Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)

    Measured: 40 months

  3. Phase I/II: Number of patients with serious TEAEs

    Measured: 40 months

  4. Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations

    Measured: 40 months

  5. Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations

    Measured: 40 months

  6. Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

    Measured: 40 months

Secondary outcomes (10)

  1. Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST

    Measured: 37 months

  2. Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST

    Measured: 40 months

  3. Phase I/II: Disease control rate (DCR) of CR, PR or stable disease (SD) (lasting 6 or more weeks) following the initiation of IMA402 based on RECIST v1.1 and iRECIST

    Measured: 40 months

  4. Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST

    Measured: 40 months

  5. Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST

    Measured: 40 months

  6. Phase I/II: Overall survival (OS)

    Measured: 40 months

  7. Phase I/II: Determination of PK parameter: half-life (t1/2)

    Measured: 40 months

  8. Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)

    Measured: 40 months

  9. Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)

    Measured: 40 months

  10. Phase I/II: Determination of PK parameter: area under the curve (AUC)

    Measured: 40 months

Timeline

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

  1. First posted24 Jul 2023
  2. Study start9 Aug 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05958121
Sponsor's protocol ID
IMA402-101
Other IDs
2022-503133-54-00
Status last verified
Aug 2026
First submitted
14 Jul 2023
Last updated
1 Sep 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMA402, IMA402 and checkpoint inhibitor and IMA402 and chemotherapy in people with Refractory Cancer and Recurrent Cancer, run by Immatics Biotechnologies GmbH at 29 sites in 2 countries.

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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, Netherlands. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Immatics Biotechnologies GmbH (Please E-Mail, Ctgovinquiries@immatics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Number of patients with dose limiting toxicities (DLTs) (time frame: 24 months). The study lists 6 primary outcomes in all. 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 NCT05958121.

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 1 Sep 2026.

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