IO Biotech has dosed the first patient in a Phase I/II IO102-012/KN-764 clinical trial evaluating IO102 in combination with Keytruda (pembrolizumab) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC).
The trial aims to determine if the combination of IO102 and pembrolizumab with or without chemotherapy is safe and effective in the treatment of NSCLC.
IO Biotech chief medical officer Eva Ehrnrooth said: “The first patient is now being treated in a first-line treatment setting of metastatic non-small cell lung cancer.
“Through this trial, we expect to get a diverse set of clinical data.
“This will enable us to explore the potential of IO102 when added to the current standard of care.”
The open-label, randomised, parallel assignment Phase I/II trial is expected to enrol around 108 patients from more than 20 sites in the US and Europe.
The primary endpoint of the Phase l portion of the trial is safety measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 over a period of three weeks.
The primary endpoint of the Phase ll portion of the study includes efficacy, which will be evaluated from the date of randomisation until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, for a period of around two years.
The trial’s secondary endpoint is objective response rate (ORR).
MSD will supply Keytruda for the trial, which will be sponsored by IO Biotech.
IO102 is an investigational IDO-derived immune modulating therapy featuring a dual mode of action that is capable of killing both cancer and immune-suppressive cells.
In a previous first-in man trial, IO102 demonstrated a favourable safety profile and promising anti-tumour activity in pre-treated patients with NSCLC.