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Atlas/Antibody-drug conjugates/Besponsa/First dose

Besponsa: how was the first human dose set?

inotuzumab ozogamicin · CD22
Check my plan vs. these
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
No NOAEL in rat or monkey chronic studies; liver (sinusoidal injury), hematolymphoid, reproductive organs; monkey glomerulonephritis death at 5 ug/kg
“Taken together, the primary inotuzumab ozogamicin target organs identified by the chronic toxicity studies were the liver, hematolymphopoietic tissues, and the male and female reproductive organs.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗

Same question, other ADCs

Elahere

mirvetuximab soravtansine · FRα
Rationale not stated; FIH Study 0401 escalated from 0.15 mg/kg (TBW) to 7.0 mg/kg

Enhertu

fam-trastuzumab deruxtecan · HER2
1/12 HED of monkey HNSTD (0.8 mg/kg), also matching minimum effective trough concentration

Kadcyla

ado-trastuzumab emtansine · HER2
HNSTD-based: monkey HNSTD 10 mg/kg (q3w x4), below 1/10 rat severely toxic dose, used to set Phase I start

Zynlonta

loncastuximab tesirine · CD19
1/6 HNSTD in cynomolgus monkey cited as rationale for species choice; actual FIH calculation not detailed

Adcetris

brentuximab vedotin · CD30
Not stated in public reviews

Datroway

datopotamab deruxtecan · Trop-2
Not stated in public reviews

Decnupaz

pivekimab sunirine · CD123
Not stated in public reviews

Emrelis

telisotuzumab vedotin · c-Met
Not stated in public reviews

Mylotarg

gemtuzumab ozogamicin · CD33
Not stated in public reviews

Padcev

enfortumab vedotin · Nectin-4
Not stated in public reviews

Polivy

polatuzumab vedotin · CD79b
Not stated in public reviews

Tivdak

tisotumab vedotin · Tissue factor
Not stated in public reviews

Trodelvy

sacituzumab govitecan · Trop-2
Not stated in public reviews

Summary across all 14 ADCs →