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ATRN-119

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Aprea Therapeutics, Inc.|Last Updated: Jan 26, 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 Enrollment132
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04905914Study Of ATRN-119 In Patients With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 132 — — Jan 9, 2023Feb 1, 2028Jan 26, 20267 United States
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Study Endpoints
Primary Endpoints
Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
Day 1 to Day 28

Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
50mg ATRN-119EXPERIMENTALOnce daily oral administration.
100mg ATRN-119EXPERIMENTALOnce daily oral administration.
200mg ATRN-119EXPERIMENTALOnce daily oral administration.
350mg ATRN-119EXPERIMENTALOnce daily oral administration.
400mg ATRN-119EXPERIMENTALTwice daily oral administration.
1100mg ATRN-119EXPERIMENTALOnce daily oral administration
1300mg ATRN-119EXPERIMENTALOnce daily oral administration
1500mg ATRN-119EXPERIMENTALOnce daily oral administration
650mg ATRN-119EXPERIMENTALTwice daily oral administration.
750mg ATRN-119EXPERIMENTALTwice daily oral administration.
550mg ATRN-119EXPERIMENTALOnce or twice daily oral administration
800 mg ATRN-119EXPERIMENTALOnce daily oral administration
Interventions
NameTypeDescription
ATRN-119DRUGATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period. * Measurable disease defined by RECIST 1.1. * Life expectancy ≥ 3 months. * Subject must be capable of oral administration of study medication. Exclusion Criter...

Countries:United States
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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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04905914primaryCompletionDate: changed
LOWMay 24, 2026NCT04905914studyFirstPostDate: changed