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IMA401

Phase 1

Refractory Cancer | Monoclonal antibody | Oncology |Immatics N.V.|Last Updated: Apr 30, 2026

Target and mechanism

Molecular targetMAGEA4/8
Target classNull
ModalityMonoclonal antibody

Also known as IMA401 (Phase Ia)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

IMA401 · 1 trial · 4 indications

Phase 1 1
NCT05359445IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint InhibitorRefractory Cancer
ACTIVE NOT_RECRUITING95 Analytics
PHASE1ACTIVE NOT_RECRUITING
IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor
Refractory CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients with dose limiting toxicities
44 months

Secondary Endpoints

Number of patients with treatment-emergent adverse events (TEAEs)
93 months
Number of patients with serious TEAEs
93 months
Number of patients with treatment emergent adverse events of special interest (AESIs)
93 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose-Finding IMA401 TCER® Monotherapy (Phase Ia)EXPERIMENTALDose-Finding Escalation/De-escalation with IMA401 TCER® (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)
Extension IMA401 TCER® Monotherapy (Phase Ib)EXPERIMENTALIMA401 monotherapy extension cohort following the determination of the recommended dose for extension (RDE) (Phase Ib)

Interventions

NameTypeDescription
IMA401 (Phase Ia)BIOLOGICALIntravenous infusions in escalating dose levels
Pembrolizumab (Phase Ia)BIOLOGICALIntravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab
IMA 401 (Phase Ib)BIOLOGICALTreatment at recommended dose for extension (RDE)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

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 consi...

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

Recent Changes (Last 90 Days)

MEDIUMMay 26, 2026NCT05359445Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT05359445studyFirstPostDate: changed

Frequently asked questions about IMA401

What is IMA401 used for?

IMA401 is an investigational monoclonal antibody being developed for the treatment of refractory cancer, including recurrent and/or refractory solid tumors in adults. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does IMA401 target?

IMA401 targets MAGEA4/8, a tumor-associated antigen. It is designed as a T cell engaging receptor (TCER) bispecific antibody to direct T cells against cancer cells expressing MAGEA4/8. This mechanism is being evaluated in the treatment of refractory solid tumors.

Who is developing IMA401?

IMA401 is being developed by Immatics N.V., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with refractory cancer.

What phase is IMA401 in?

IMA401 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and potential efficacy in treating refractory solid tumors.

What clinical trials is IMA401 in?

IMA401 is being studied in a Phase 1 clinical trial with the identifier NCT05359445. This trial is evaluating IMA401 alone or in combination with a checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. The trial is active but not recruiting participants.

Is IMA401 the same as IMA401 (Phase Ia)?

Yes, IMA401 is also referred to as IMA401 (Phase Ia). This alternative name reflects the specific phase of clinical development for this investigational drug, which is being studied in a Phase 1 trial for refractory cancer.