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EOS-448

Phase 1

Advanced Cancer | Small molecule | Oncology |iTeos Therapeutics, Inc.|Last Updated: Jun 21, 2024

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 Enrollment153
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05060432Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 153Sep 6, 2021Jul 1, 2025Jun 21, 202442 United States, Belgium +4
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Study Endpoints
Primary Endpoints
Percentage of participants with DLT and Adverse Events
From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose
Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors
Up to 48 weeks
Percentage of participants with Objective Response as determined by Investigator
Until disease progression - Approximately 48 months
Secondary Endpoints
Duration of Response (DOR)
Until disease progression or death - Approximately 48 months
Disease Control Rate (DCR)
Until disease progression or death - Approximately 48 months
Progression-free-survival (PFS)
Until disease progression or death - Approximately 48 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A - EOS-448 + pembrolizumabEXPERIMENTALParticipants will receive EOS-448 and pembrolizumab at every cycle
Part 1B - EOS-448 + inupadenantEXPERIMENTALParticipants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Part 1C - EOS-448 + inupadenantEXPERIMENTALParticipants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
Part 1D - EOS-448 + dostarlimabEXPERIMENTALParticipants will receive EOS-448 and dostarlimab at every cycle
Part 1E - inupadenant HCl + dostarlimabEXPERIMENTALParticipants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
Part 1F - EOS-448 + dostarlimab + inupadenant HCEXPERIMENTALParticipants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
Part 1G - EOS-448 + dostarlimab + chemotherapiesEXPERIMENTALParticipants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
Part 2C - EOS-448 + dostarlimabEXPERIMENTALParticipants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
Part 2D - EOS-448 + dostarlimabEXPERIMENTALParticipants with 1L mHNSCC 1 \< CPS \< 20 will receive EOS-448 and dostarlimab at every cycle
Interventions
NameTypeDescription
EOS-448DRUGAnti-TIGIT monoclonal antibody
pembrolizumabDRUGAnti-PD-1 monoclonal antibody
inupadenantDRUGA2A receptor antagonist
DostarlimabDRUGAnti-PD-1 monoclonal antibody
SOC chemotherapiesDRUGSOC chemotherapies in 1L mNSCLC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Provide a signed written informed consent for the trial * Have measurable disease, per RECIST v1.1 * Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1. * Have adequate organ functions * Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologic...

Countries:United StatesBelgiumFranceItalySpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05060432primaryCompletionDate: changed
LOWMay 24, 2026NCT05060432studyFirstPostDate: changed