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IMA401

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05359445IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint InhibitorPHASE1 ACTIVE NOT_RECRUITING 95May 19, 2022Dec 1, 2029Apr 30, 202621 Germany
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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 — 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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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05359445Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT05359445studyFirstPostDate: changed