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IO102

Phase 1/2

NSCLC | Vaccines | Oncology |IO Biotech, Inc.|Trials Updated: Apr 21, 2022

IO102 development status

Highest phase Phase 1/2
Registered trials 1 across 1 sponsor since Jun 2018

IO102 target and mechanism

Molecular targetPD-L1
Target classProtein
ModalityVaccines

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment109

FDA Designations

No designations recorded

IO102 clinical trials

IO102 · 1 trial · 1 indication

Phase 1/2 1
NCT03562871IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLCNSCLC
COMPLETED109 Analytics
PHASE1/PHASE2COMPLETED
IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC
NSCLCUnlock trial analytics

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 to 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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Frequently asked questions about IO102

What is IO102?

IO102 is an investigational therapeutic vaccine developed by IO Biotech for non-small cell lung cancer (NSCLC). It is designed to target PD-L1, a protein found on tumor and immune cells. IO102 has been studied in a Phase 1/2 clinical trial as a first-line treatment for metastatic NSCLC, in combination with pembrolizumab with or without chemotherapy.

What does IO102 target?

IO102 targets PD-L1, a protein target. By directing an immune response against cells expressing PD-L1, the vaccine approach is intended to act on this protein target. PD-L1 is also the target of checkpoint inhibitor therapies, and IO102 was studied alongside pembrolizumab in metastatic NSCLC.

Who is developing IO102?

IO102 is being developed by IO Biotech, Inc., which trades under the ticker IOBTQ. The company is the sponsor of the clinical program evaluating IO102 in non-small cell lung cancer.

What phase is IO102 in?

IO102 is in Phase 1/2 clinical development and is investigational. Its single recorded trial, NCT03562871, is a Phase 1/Phase 2 study that has been completed. IO102 has been evaluated in metastatic NSCLC as a first-line treatment combined with pembrolizumab, with or without chemotherapy.

What clinical trials is IO102 in?

IO102 has been studied in trial NCT03562871, titled "IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC." The Phase 1/Phase 2 trial enrolled 109 patients across Germany, the Netherlands, Spain, and the United Kingdom, was randomized and active-controlled, and has completed.

What is IO102 used for in NSCLC?

IO102 is being studied for non-small cell lung cancer (NSCLC), specifically as a first-line treatment for metastatic disease. In trial NCT03562871 it was given with pembrolizumab, with or without chemotherapy, in adults 18 years and older. IO102 remains investigational and is not established as an approved therapy.