In this study, patients with either advanced solid tumors or non-Hodgkin’s lymphoma (NHL) will receive a three-hour intravenous (IV) infusion of RH1 administered once every 21 days.
Patients will receive starting doses of RH1 at 1.5mg/m2, with dose escalation in subsequent cohorts based on toxicity. Up to 60 evaluable patients will be enrolled in the study with the objective of determining the maximum tolerated dose (MTD), recommended Phase II dose and safety profile of RH1 in this population.
Three to six patients will be enrolled per cohort. An expanded cohort of up to 24 evaluable patients who have tumor types with a high likelihood of DTD over-expression will be recruited to explore possible markers of anticancer activity.
Pablo Cagnoni, chief medical officer of Allos, said: “We are pleased to advance the development of this agent. RH1 is a small molecule chemotherapeutic agent that is bioactivated by the enzyme DT-diaphorase (DTD), which is over-expressed in many tumors, including lung, colon, breast and liver tumors. We believe that because RH1 is bioactivated in the presence of DTD, it has the potential to preferentially target certain tumors while limiting the amount of toxicity to normal tissue.”