Request an invite
Atlas/Antibody-drug conjugates/Tivdak/First dose

Tivdak: how was the first human dose set?

tisotumab vedotin · Tissue factor
Check my plan vs. these
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
Monkey NOAEL 1 mg/kg (females; <1 mg/kg males), HNSTD 3 mg/kg; skin, bone marrow, eye, testes; skin deaths at 5 mg/kg
“The NOAEL for males was <1 mg/kg. The applicant also provided exposure (Cmax and AUC) ratios between monkey and human at the highest non-severely toxic dose of 3 mg/kg, which was approximately 1.35- to 2.56-fold that in humans.”
✓ VerifiedEMA assessment report, p. 50Source ↗

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

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

Trodelvy

sacituzumab govitecan · Trop-2
Not stated in public reviews

Summary across all 14 ADCs →