Alewine CC, et al. - Considering the pre-clinical data suggesting the synergistic anti-tumor activity of a combination of LMB-100 with a taxane, researchers conducted a phase I single-center study (standard 3+3 design) assessing the maximum tolerated dose (MTD) of LMB-100 given with nab-paclitaxel in patients with previously treated advanced pancreatic adenocarcinomas (PDAC). They enrolled 14 patients (median age 58). At the 100 mcg/kg dose of LMB-100, 2 of 6 patients experienced DLTs (myalgia- 2 pts, fatigue- 1 pt, hypotension- 1 pt; all grade 3). DLT was noted in 1 of 8 patients at the 65 mcg/kg dose (edema, urine output decrease- both grade 3). Hypoalbuminemia, edema-associated weight gain, hyponatremia, fatigue, drug fever, infusion-related reaction, hypophosphatemia, nausea and anorexia were the other toxicities related to LMB-100. On this schedule, MTD of LMB-100 is 65 mcg/kg given with nab-paclitaxel. Findings support its anti-tumor activity. Currently, a phase II cohort is being accrued.