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IO-108

Phase 1

Solid Tumor, Adult | Monoclonal antibody | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 4, 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 Enrollment91
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05054348First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid TumorsPHASE1 COMPLETED 91 — — Sep 30, 2021May 31, 2024Jun 4, 202424 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent and serious adverse events in patients treated with IO-108 and IO-108+pembrolizumab
From first dose of IO-108 until the end of treatment which is up to 2 years from the first treatment date or disease progression whichever is earlier

safety and tolerability as measured by the incidence of treatment-emergent adverse events and serious adverse events

Determine MTD (maximum tolerated dose) through assessment of dose-limiting toxicities (DLT)
From the first dose of IO-108 until 21 days post-treatment

MTD will be determined through observation of pre-determined DLTs in each dose cohort

Assess safety and tolerability of the IO-108 RP2D as monotherapy or in combination with either pembrolizumab or cemiplimab in patients with solid tumors
From the first dose of IO-108 until the end of treatment which is up to 2 years from the first treatment or disease progression, whicheer is earlier

safety and tolerability as measured by the incidence of treatment-emergent adverse events and discontinuation due to TEAEs

Secondary Endpoints
Maximum plasma concentration (Cmax) of IO-108
From the first dose of IO-108 until day 15 post-treatment
Steady state concentration of IO-108
From the second dose of IO-108 until the last treatment which is up to 2 years from the first treatment date
Immunogenicity of IO-108 and IO-108+pembrolizumab
From the first dose until 30 days after the last treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IO-108 MonotherapyEXPERIMENTALTreatment of patients with advanced solid tumors with IO-108 monotherapy
IO-108 + pembrolizumab combination therapyEXPERIMENTALTreatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of pembrolizumab
IO-108 + cemiplimab combination therapyEXPERIMENTALTreatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of cemiplimab
Interventions
NameTypeDescription
IO-108BIOLOGICALIO-108 given as monotherapy
IO-108 + pembrolizumab combination therapyBIOLOGICALIO-108 and fixed dose pembrolizumab combination therapy
IO-108 + cemiplimab combination therapyBIOLOGICALIO-108 and fixed dose cemiplimab combination therapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Patients must be ≥18. 2. Has any histologically- or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, has been intolerant to, or has been ineligible for standard systemic therapy known to confer clinical benefit. Solid tumors of any...

Countries:United States
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