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EOS301984

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |iTeos Therapeutics, Inc.|Last Updated: Aug 13, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06547957A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 55 — — Jul 7, 2023Dec 1, 2025Aug 13, 20256 Belgium
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Study Endpoints
Primary Endpoints
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors
From first study treatment administration to last participant last follow-up (Up to 4 years)
Incidence and severity of AEs in patients receiving EEOS301984
From first study treatment administration to last participant last follow-up (Up to 4 years)
Secondary Endpoints
Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level
From first dose up to 21 days repeated cycles
Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level
From first dose up to 21 days repeated cycles
Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.
From first study treatment administration to last participant last follow-up (Up to 4 years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A dose escalationEXPERIMENTALEOS301984 dose escalation as monotherapy
Part 1B dose escalationEXPERIMENTALEOS301984 in combination with other cancer therapies
Interventions
NameTypeDescription
EOS301984DRUGMultiple doses of EOS301984
Anti-PD-1 monoclonal antibodyDRUGMultiple doses of EOS301984 in combination with Anti-PD-1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

INCLUSION CRITERIA * Provide a signed written informed consent before any study-specific evaluation. * Be at least 18 years old on the day of signing informed consent. * Have a histologically confirmed advanced solid tumor for which no standard approved treatment is available, or are ineligible for...

Countries:Belgium
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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, 2026NCT06547957primaryCompletionDate: changed
LOWMay 24, 2026NCT06547957studyFirstPostDate: changed