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IMA402

Phase 1

Refractory Cancer | Small molecule | Oncology |Immatics N.V.|Last Updated: Sep 1, 2026

Target and mechanism

Molecular targetPRAME
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

IMA402 · 1 trial · 4 indications

Phase 1 1
NCT05958121IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid TumorsRefractory Cancer
RECRUITING400 Analytics
PHASE1RECRUITING
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
Refractory CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase I: Number of patients with dose limiting toxicities (DLTs)
24 months
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
40 months
Phase I/II: Number of patients with serious TEAEs
40 months
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
40 months
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
40 months
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)
40 months

Secondary Endpoints

Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
37 months
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
40 months
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
40 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose escalation/de-escalation (Phase Ia)EXPERIMENTALDose-Finding of IMA402 as monotherapy or in combination with checkpoint inhibitor (Phase Ia)
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)
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)

Interventions

NameTypeDescription
IMA402DRUGIV infusions
IMA402 and checkpoint inhibitorDRUGIMA402 IV infusions and checkpoint inhibitor
IMA402 and chemotherapyDRUGIMA402 IV infusions and chemotherapy
IMA402 and IMA401DRUGIMA402 and IMA401 IV infusions
IMA402 and monoclonal antibodyDRUGIMA402 IV infusions and monoclonal antibody
IMA402 and chemotherapy +/- monoclonal antibodyDRUGIMA402 IV infusions and chemotherapy +/- monoclonal antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites29

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 accordin...

Countries:GermanyNetherlands
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Competitive Landscape -Cancer 5 trials (matched to "Refractory Cancer")

Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT05958121lastUpdatePostDate: changed
LOWSep 1, 2026NCT05958121lastUpdatePostDate: changed
MEDIUMJul 2, 2026NCT05958121Enrollment: 145 → 400
MEDIUMJul 2, 2026NCT05958121Enrollment: 145 → 400
MEDIUMJul 2, 2026NCT05958121Enrollment: 145 → 400
MEDIUMJul 2, 2026NCT05958121Enrollment: 145 → 400

Frequently asked questions about IMA402

What is IMA402 used for?

IMA402 is an investigational T cell-engaging receptor molecule (TCER) being developed for the treatment of refractory cancer, recurrent cancer, and solid tumors in adults. It is currently in Phase 1 clinical development for these oncology indications.

What does IMA402 target?

IMA402 targets PRAME, a tumor-associated antigen. It is designed as a T cell-engaging receptor molecule (TCER) to direct T cells against PRAME-expressing tumor cells. The drug is being studied in patients with recurrent and/or refractory solid tumors.

Who makes IMA402?

IMA402 is being developed by Immatics N.V., a biopharmaceutical company. Immatics is publicly traded under the ticker symbol IMTX. The company is conducting clinical trials of IMA402 in Germany and the Netherlands.

What phase is IMA402 in?

IMA402 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants with recurrent and/or refractory solid tumors.

What clinical trials is IMA402 in?

IMA402 is being studied in a Phase 1 clinical trial with the identifier NCT05958121. This trial is titled 'IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors' and is currently recruiting participants in Germany and the Netherlands.

Is IMA402 the same as a TCER?

IMA402 is a T cell-engaging receptor molecule, also referred to as a TCER. It is designed to engage T cells to target PRAME-expressing tumor cells. The ongoing clinical trial specifically evaluates IMA402 as a TCER in patients with recurrent and/or refractory solid tumors.