Nektar Therapeutics has dosed the first patient in the REVEAL study, a Phase I/II clinical trial designed to analyse the efficacy and safety of NKTR-262 in combination with NKTR-214 for the treatment of solid tumours.
Sponsored by Nektar, the dose escalation/expansion study aims to examine the combination of NKTR-262 administered as an initial intratumoral injection followed by NKTR-214 administered as an IV infusion systemically (doublet).
The trial will also investigate the doublet combination with nivolumab (triplet).
The dose escalation phases of the trial intend to establish recommended Phase 2 dose (RP2D) regimens of the doublet and/or triplet combinations.
After completing the dose escalation phase, the trial will begin the dose expansion phase.
The dose expansion phase will analyse the doublet and/or triplet combinations in up to 350 patients who have been diagnosed with various locally advanced or metastatic cancers such as melanoma, Merkel cell carcinoma, triple-negative breast cancer, ovarian cancer, renal cell carcinoma, colorectal cancer, urothelial carcinoma, or sarcoma.
Nektar Therapeutics Clinical Development senior vice-president and chief medical officer Mary Tagliaferri said: “The REVEAL study is intended to show the synergistic impact on the entire immune activation cascade of an initial intratumoral injection of NKTR-262 followed by treatment with NKTR-214.
“Engagement of the innate and adaptive immune cascades is the most effective way to restore immune surveillance mechanisms to drive both local tumour antigen production and a specific and sustained T cell response to attack a patient's tumours.
“We believe the combination approach of these two novel immuno-oncology agents could ultimately help patients with many types of advanced or metastatic solid tumour cancers, including those resistant to existing immunotherapies.”
NKTR-262 is a new toll-like receptor (TLR) agonist that can induce the body’s innate immune response and create antigen-specific T cells to fight cancer.
NKTR-214 is developed to activate the adaptive immune system to expand and multiply these specific cancer-fighting T cells in the tumour micro-environment.