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IMA101 product

Phase 1

Cancer | 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02876510ACTolog in Patients With Solid CancersPHASE1 COMPLETED 38Jun 30, 2017Sep 22, 2021Feb 4, 20251 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events (Safety and tolerability) of IMA101 alone or in combination with atezolizumab
up to 18 months
Secondary Endpoints
Peripheral T-cell persistence (assessment of frequency of T-cells over time)
up to 18 months
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
up to 18 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IMA101 product only (Cohort 1)EXPERIMENTAL* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * Infusion of the IMA101 T-cell product(s) * Post-infusion administration of low-dose recombinant human interleukin-2
IMA101 product + atezolizumab (Cohort 2)EXPERIMENTAL* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * Infusion of the IMA101 T-cell product(s) * Post-infusion administration of low-dose recombinant human interleukin-2 * Treatment with atezolizumab every 3 weeks after IMA101 product infusion, for 1 year
Interventions
NameTypeDescription
FludarabineDRUGFludarabine infusion
CyclophosphamideDRUGCyclophosphamide infusion
IMA101 productBIOLOGICALi.v. infusion of IMA101 product(s).
Recombinant human interleukin-2BIOLOGICALLow dose IL-2 Infusion for two weeks
IMADetectDIAGNOSTIC_TESTIMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.
AtezolizumabDRUGAtezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients must have pathologically confirmed advanced/metastatic cancer prior to enrollment. 2. HLA phenotype positive. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Life expectancy \> 6 months prior to enrollment. 5. Patient is a candidate for a maxi...

Countries:United States
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