HYB2055 (also known as IMO-2055 or IMOxine) is Idera’s lead toll-like receptor 9 (TLR9) agonist for the treatment of cancer. The phase I/II trial is a two-phase study to evaluate the safety and efficacy of HYB2055 combined with a standard gemcitabine/carboplatin treatment regimen.
The primary endpoint of the phase I portion of the trial is to establish an appropriate HYB2055 dose in combination with a fixed dose of gemcitabine/carboplatin in patients with solid tumors.
In the phase II portion, the primary endpoint is overall response rate and toxicity of the triplet combination in previously untreated, advanced non-small cell lung cancer patients.
Idera also recently announced that it had expanded its ongoing phase II trial of HYB2055 monotherapy in patients with renal cell carcinoma, extending the enrollment targets to 46 treatment-naive and 46 second-line patients.
The company is also planning additional trials to assess HYB2055 in other oncology indications.