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IO102

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment109

FDA Designations

BREAKTHROUGH_THERAPY

Clinical trial landscape

IO102 · 1 trial · 1 indication

Phase 1 1
NCT03562871IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLCNSCLC
COMPLETED109 Analytics
PHASE1COMPLETED
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 used for in NSCLC?

IO102 is an investigational monoclonal antibody being studied for the treatment of non-small cell lung cancer (NSCLC). It is being evaluated as a first-line treatment for metastatic NSCLC in combination with pembrolizumab, with or without chemotherapy. The drug is currently in Phase 1 clinical development.

What does IO102 target?

IO102 is a monoclonal antibody designed to target a specific molecular pathway involved in cancer. As a therapeutic antibody, it is intended to modulate the immune response against tumor cells. The exact molecular target of IO102 has not been disclosed in the available information.

Who makes IO102?

IO102 is being developed by IO Biotech, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IOBT. IO Biotech is responsible for the clinical development and regulatory strategy for IO102.

What phase is IO102 in?

IO102 is currently in Phase 1 clinical development. It has completed a Phase 1 trial in patients with metastatic NSCLC. The drug has not yet been approved by regulatory authorities and remains an investigational agent under clinical investigation.

What clinical trials is IO102 in?

IO102 has been studied in one clinical trial, identified as NCT03562871. This Phase 1 trial evaluated IO102 in combination with pembrolizumab, with or without chemotherapy, as first-line treatment for metastatic NSCLC. The trial enrolled 109 participants and has been completed.

Is IO102 the same as any other drug?

IO102 is not known to have any alternative names. It is a distinct investigational monoclonal antibody developed by IO Biotech. No other names or aliases for IO102 have been reported in the available information.