Adcetris
brentuximab vedotin · CD3026 weeks
Trodelvy: how long were the pivotal tox studies?
sacituzumab govitecan · Trop-2
Longest pivotal study
13 weeks
“In a 13-week toxicity study, monkeys were given sacituzumab govitecan at doses of 12.5, 25, and 50 mg/kg once weekly via a 1-hour infusion for 2 weeks of a 3-week cycle for 4 treatment cycles.”
Pivotal GLP studies
GLP monkey 2-dose acute study (60, 120 mg/kg) and 13-week monkey study (days 1, 8 q21d x4 cycles, 6-week recovery), IV
“In a 13-week toxicity study, monkeys were given sacituzumab govitecan at doses of 12.5, 25, and 50 mg/kg once weekly via a 1-hour infusion for 2 weeks of a 3-week cycle for 4 treatment cycles.”
Route in tox
IV (1-hour infusion, clinical route); IP in non-GLP mouse studies
“Dose and frequency of dosing: 0, 60, & 120 mg/kg; 2 doses three days apart (days 1 and 4) Route of administration: IV (1-hr)”
Same question, other ADCs
Besponsa
inotuzumab ozogamicin · CD2226 weeks
Datroway
datopotamab deruxtecan · Trop-213 weeks
Decnupaz
pivekimab sunirine · CD12313 weeks
Elahere
mirvetuximab soravtansine · FRα10 weeks
Emrelis
telisotuzumab vedotin · c-Met13 weeks
Enhertu
fam-trastuzumab deruxtecan · HER213 weeks
Kadcyla
ado-trastuzumab emtansine · HER226 weeks
Mylotarg
gemtuzumab ozogamicin · CD3312 weeks
Padcev
enfortumab vedotin · Nectin-413 weeks
Polivy
polatuzumab vedotin · CD79b10 weeks
Tivdak
tisotumab vedotin · Tissue factor13 weeks
Zynlonta
loncastuximab tesirine · CD1913 weeks