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IMA201 Product

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |Immatics N.V.|Last Updated: Feb 4, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03247309TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)PHASE1 COMPLETED 7 — — Dec 19, 2018Sep 18, 2023Feb 4, 20255 United States, Germany
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AE)
up to 3 years post-treatment
Determination of the maximum tolerated dose (MTD)
until 21 days post treatment
Secondary Endpoints
Duration of infused T cells over time (Persistence of T cells)
up to 3 years post-treatment
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
up to 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IMA201 ProductEXPERIMENTAL* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * One dose of IMA201 product will be infused intravenously. Up to four dose levels will be evaluated. At least two patients per cohort will be treated. * Post-infusion of IMA201 product, administration of low-dose recombinant human interleukin-2
Interventions
NameTypeDescription
IMA201 ProductBIOLOGICALThe cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
IMADetect®DIAGNOSTIC_TESTIMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patient ≥ 18 years of age * Pathologically confirmed advanced and/or metastatic solid tumor * Patients may enter screening procedure before, during, or after the last available indicated standard of care treatment. There is no limitation for prior anti cancer treatments. * Eas...

Countries:United StatesGermany
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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