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IMA402

Phase 1

Refractory Cancer | Monoclonal antibody | Oncology |Immatics N.V.|Last Updated: Nov 18, 2025

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 Enrollment145
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05958121IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid TumorsPHASE1 RECRUITING 145 — — Aug 9, 2023Sep 1, 2027Nov 18, 202524 Germany, Netherlands
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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 (Phase Ia)
Dose extension (Phase Ib)EXPERIMENTALIMA402 monotherapy extension cohorts 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
IMA402 (Phase Ia)BIOLOGICALIntravenous infusions in escalating dose levels
IMA402 (Phase Ib)BIOLOGICALTreatment at MTD and/or RDE (Phase Ib)
IMA402 (Phase II)BIOLOGICALTreatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

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 all available indicated standard-of-care treatments * Measurable disease accor...

Countries:GermanyNetherlands
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05958121primaryCompletionDate: changed
LOWMay 24, 2026NCT05958121studyFirstPostDate: changed