AST-001 / Ascentawits Pharma - LARVOL DELTA

Characterization of AST-001 non-clinical pharmacokinetics: A novel selective AKR1C3-activated prodrug in mice, rats, and cynomolgus monkeys. (PubMed, Biopharm Drug Dispos) - "AST-001 is a chemically synthesized inactive nitrogen mustard prodrug that is selectively cleaved to a cytotoxic aziridine (AST-2660) via aldo-keto reductase family 1 member C3 (AKR1C3). Following a single intravenous dose, AST-001 was not excreted primarily as the prodrug, AST-001 or the metabolite AST-2660 in the urine, feces, and bile. A comprehensive analysis of the preclinical data and inter-species allometric scaling were used to estimate the pharmacokinetic parameters of AST-001 in humans and led to the recommendation of a starting dose of 5 mg/m2 in the first-in-human dose escalation study."

Journal • PK/PD data • Preclinical • Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

AT-001-001: A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Ascentawits Pharmaceuticals, Ltd

New P1/2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor