Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IO102 · 1 trial · 1 indication
Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Objective Response Rate (ORR) evaluated by RECIST 1.1 and defined as the rate of complete response (CR) + partial response (PR)
| Arm | Type | Description |
|---|---|---|
| Cohort A1 | EXPERIMENTAL | Drug: 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 A2 | ACTIVE_COMPARATOR | Drug: pembrolizumab (Keytruda) 200 mg IV infusion on Day 1 of each 3 week cycle |
| Cohort B1 | EXPERIMENTAL | Drug: 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 B2 | ACTIVE_COMPARATOR | 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 |
| Name | Type | Description |
|---|---|---|
| IO102 | BIOLOGICAL | test immunotherapy |
| pembrolizumab (Keytruda) | BIOLOGICAL | anti-PD-1 immunotherapy |
| Carboplatin (Carboplatin Kabi) | DRUG | chemotherapy |
| Pemetrexed (Pemetrexed Alvogen) | DRUG | chemotherapy |
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...
IO102 is an investigational therapy being studied for non-small cell lung cancer (NSCLC). It was evaluated as a first-line treatment for metastatic NSCLC, given together with pembrolizumab, with or without chemotherapy. IO102 is not yet approved for any indication and remains in clinical development.
IO102 targets PD-L1, a protein that tumors use to suppress immune responses. By binding PD-L1, IO102 is designed to interfere with that immune evasion pathway. It is described as a monoclonal antibody modality in oncology development.
IO102 is being developed by IO Biotech, Inc., which trades under the ticker IOBT. The company sponsored the clinical program evaluating IO102 in non-small cell lung cancer.
IO102 is in Phase 1 clinical development. The program's single trial, NCT03562871, has completed, and no trials are currently listed as active. IO102 is investigational and has not been approved by the FDA for any use.
IO102 has been studied in one clinical trial, NCT03562871, titled "IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC." The Phase 1 trial enrolled 109 participants across Germany, Netherlands, Spain, and the United Kingdom, and it has completed.
NCT03562871 was a randomized, active-controlled Phase 1 trial of IO102 plus pembrolizumab, with or without chemotherapy, as first-line treatment for metastatic NSCLC. It enrolled 109 adults aged 18 and older, included both sexes, used a biomarker-selected population, and was not double-blind.