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IO102

Phase 1

NSCLC | Monoclonal antibody | Other |IO Biotech, Inc.|Last Updated: Apr 21, 2022

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment109
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03562871IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLCPHASE1 COMPLETED 109 — — Aug 22, 2018Apr 12, 2022Apr 21, 202213 Germany, Netherlands +2
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Study Endpoints
Primary Endpoints
Phase 1 (safety run-in)
One cycle i.e. 3 weeks

Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Phase 2 (efficacy)
From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years)

Objective Response Rate (ORR) evaluated by RECIST 1.1 and defined as the rate of complete response (CR) + partial response (PR)

Secondary Endpoints
ORR
From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A1EXPERIMENTALDrug: IO102 100µg administered subcutaneously (SC) on Day 1 of each 3 week cycle PLUS Drug: pembrolizumab (Keytruda) 200 mg intravenous (IV) infusion on Day 1 of each 3 week cycle
Cohort A2ACTIVE_COMPARATORDrug: pembrolizumab (Keytruda) 200 mg IV infusion on Day 1 of each 3 week cycle
Cohort B1EXPERIMENTALDrug: IO102 100µg SC on Day 1 of each 3 week cycle PLUS Drug: pembrolizumab (Keytruda) 200 mg IV on Day 1 of each 3 week cycle PLUS Drug: carboplatin (Carboplatin Kabi) at a target AUC of 5 mg/mL IV infusion on Day 1 of each 3 week cycle for a max of 4 administrations PLUS Drug: pemetrexed (Pemetrexed Alvogen) at 500 mg/m2 IV infusion on Day 1 of each 3 week cycle
Cohort B2ACTIVE_COMPARATORDrug: pembrolizumab (Keytruda) 200 mg IV on Day 1 of each 3 week cycle PLUS Drug: carboplatin (Carboplatin Kabi) at a target AUC of 5 mg/mL IV infusion on Day 1 of each 3 week cycle for a max of 4 administrations PLUS Drug: pemetrexed (Pemetrexed Alvogen) at 500 mg/m2 IV infusion on Day 1 of each 3 week cycle
Interventions
NameTypeDescription
IO102BIOLOGICALtest immunotherapy
pembrolizumab (Keytruda)BIOLOGICALanti-PD-1 immunotherapy
Carboplatin (Carboplatin Kabi)DRUGchemotherapy
Pemetrexed (Pemetrexed Alvogen)DRUGchemotherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Histologically or cytologically confirmed metastatic NSCLC or non squamous NSCLC * Have biomarker-positive solid tumor * Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study medication through 1...

Countries:GermanyNetherlandsSpainUnited Kingdom
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