Phase I trial of coramsine (SBP002) in patients with advanced solid tumors

3105 Background: Coramsine (SBP002) is a 1:1 mixture of solasonine and solamargine, plant glycoalkaloids found in the species Solanum linneanum, which have single agent and synergistic combination in vitro and in vivo preclinical efficacy in various tumor models through interaction with rhamnose-containing cell membrane glycoproteins and subsequent internalization. Methods: Coramsine as a 2 hour IV infusion daily x 5 every 2 weeks to define the MTD, recommended Phase II dose, toxicity and pharmacokinetics. Based on preclinical toxicology the infusion was increased to 4 hours at the MTD. Results: 19 previously treated advanced solid tumor pts with PS 0–2 were entered (melanoma 4, renal 4, sarcoma 2, mesothelioma 2, NSCLC 2, other 5). DLT occurred in 2/2 pts at 1.5mg/kg/day (2hr) and 2/2 pts at 3.0mg/kg/day (4hr). Limiting toxicity was grade III/IV transaminitis with grade I-II increases of bilirubin and creatinine. Hepatotoxicity was maximal at days 3–5, resolved over 10–21 days, was clinically asymptomati...