Danyelza: how was the first human dose set?

“The initial clinical trials investigating the activity and dosing of naxitamab were conducted on the basis of previous clinical data with the murine parent antibody rather than supported by toxicology data with the clinical candidate.”

“In the 13-week study, adverse findings in histopathology evaluations of the stomach resulted in the NOAEL to be established at 10 mg/kg/day (30 mg/kg per cycle) in male rats only”