Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer

Photoimmunotherapy (PIT) is a new cancer targeted technology invented at the National Cancer Institute, USA. This clinical study evaluates the treatment of the experimental drug RM-1929 with Photoimmunotherapy (PIT). The experimental drug, RM-1929, is a parental formulation consisting of a chemical conjugate of the dye IR700 with the FDA approved antibody, Erbitux® (Cetuximab), that targets EGFR receptors (EGFR is a cancer expressed protein, a cancer antigen). EGFR is highly expressed in squamous cell carcinomas of the head and neck (HNSCC). It is expected that systemic administration of RM-1929 will lead to tumor accumulation and binding to EGFR expressed at cancer cells. It is expected that treatment with RM-1929 and Photoimmunotherapy can lead to the selective destruction of the HNSCC cancer cells and provide an effective therapy to manage the disease. The treatment using RM-1929 with Photoimmunotherapy requires two steps: (i) the administration by infusion of the drug RM-1929 targeting the cancer protein EGFR AND (ii) the illumination of the tumor with red light (690 nm) using sufficient energy to activate the drug and induce cancer cell killing. Light illumination is applied at 24 h post drug infusion to enable sufficient time for the drug to distribute in the tumor after administration. Cell killing occurs only at cancer cells expressing the protein EGFR that is bound to the drug RM-1929. The requirement of binding of the drug to EGFR of cancer cells enables the selective destruction of cancer cells with minimum damage of healthy tissue surrounding the tumor cells. Preclinical pharmacology demonstrated that light-induced activation of RM-1929 elicits rapid tumor destruction of human cancer xenografts implanted in mice and that the treatment is cancer specific. The Part 1 study has been completed and consisted of a single cycle 3+3 dose escalation study of RM-1929 to determine the safety of the treatment and the maximal feasible dose of RM-1929. From the part 1 of this study, the maximal feasible dose for treatment with RM-1929 was selected. The currently ongoing Part 2 of the clinical study is evaluating the safety and anti-cancer activity of up to 4 repeat treatment cycles of Photoimmunotherapy with RM-1929.