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Atlas/Antibody-drug conjugates/Decnupaz/First dose

Decnupaz: how was the first human dose set?

pivekimab sunirine · CD123
Check my plan vs. these
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
FDA: no NOAEL in 13-week (thymic atrophy ≥0.01 mg/kg); single-dose max nonlethal 0.4 mg/kg; marrow, GI, skin, thymus
“Adverse toxicity was observed at all doses since even the lowest tested dose of 0.01 Ab mg/kg produced thymic atrophy in males.”
✓ VerifiedFDA multi-discipline review, p. 61Source ↗

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

Besponsa

inotuzumab ozogamicin · CD22
Not stated in public reviews

Datroway

datopotamab deruxtecan · Trop-2
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 →