ADC TOXICITY ATLAS
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Datopotamab deruxtecan

FDA-approved
Datroway; Dato-DXd; DS-1062
Sponsor
Daiichi Sankyo/AstraZeneca
Indication
TACSTD2+ breast/NSCLC
Target family
TACSTD / EpCAM-TROP
RP2D dose
6 mg/kg
Q3WRP2D
01
Multi-organ toxicity

Fingerprint & organ drill-down

Also reported
0%severity100%
0
Assessed · clear
true 0%
No data
never assessed
6 adverse-event terms

Ocular

Any-grade
38%
G3+
3.4%
RP2D
sagittal schematic · Reversible

Tissues shaded by reported adverse-event rate.

Cornea
AE
24%
Express.
65.43%
Limbus
AE
-
Express.
73.31%
Conjunctiva
AE
-
Express.
86.39%
Lens
AE
-
Express.
-
Retina / RPE
AE
-
Express.
0%
0 nTPM
Off-target signature

24% corneal toxicity, yet the TROP-2 target is detected in only 65.43% of central cornea - toxicity is not explained by target expression.

Dominant tissue
Ocular surface
Surface subtype
Corneal (off-target)
Reversibility
Reversible
Reported ocular events
Ocular toxicity (any ocular adverse reaction)38%
G3+ 3.4%n=1365
Keratitis26%
G3+ 6%n=319
Dry eye26%
G3+ 1.3%n=319
Lacrimation increased6%
n=1365
Conjunctivitis5%
n=1365
Blepharitis; Meibomian gland dysfunction; Blurred vision (named ocular PTs without quantified rate)-
n=1365
02
Construct

Molecular anatomy

Antibody
IgG1
Humanized
Linker
Cleavable
4
DAR
Payload
TopoI inhibitor
Linker structureC25H31N5O8
[H]OC(=O)C([H])([H])N([H])C(=O)[C@@]([H])(N([H])C(=O)C([H])([H])N([H])C(=O)C([H])([H])N([H])C(=O)C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])N1C(=O)C([H])=C([H])C1=O)C([H])([H])c1c([H])c([H])c([H])c([H])c1[H]
Payload structureC26H24FN3O6
CCC1(C2=C(COC1=O)C(=O)N3CC4=C5C(CCC6=C5C(=CC(=C6C)F)N=C4C3=C2)NC(=O)CO)O
03
Antibody

Antibody & Fc engineering

Antibody
datopotamab
Isotype
IgG1
Origin
Humanized
Fc modifications
None
Glycoengineering
Standard
Effector silencing
None
FcγR binding
Retained
C1q binding
Retained
04
Linker & conjugation

Linker chemistry

Linker profile
Linker
GGFG tetrapeptide
Class
Cleavable
Cleavage
Cleavable
Attachment
Cysteine (interchain)
Conjugation
Conventional interchain Cys
Symmetry
Symmetric
DAR (mean)
4
DAR homogeneity
Heterogeneous
Plasma t½
4.8 d
Cleavage trigger
Cathepsin B/L (GGFG tetrapeptide)
Release control
Conditional
Hydrophilicity mask
Hydrophilic-linker
Formula
C25H31N5O8
Linker MW
529.55 Da
Linker TPSA
191.08 Ų
Linker xLogP
-1.3675
ADCdb linker
LIN0ECMCR
In-vitro stability
>94%@21d/plasma
Stability note
Median elimination t½ 4.8 d (range 1.0–8.2) for Dato-DXd; released DXd t½ ~5.5 d. Same linker chemistry as T-DXd (1–2% DXd released at 21 d in plasma); shorter t½ than T-DXd reflects DAR 4 vs DAR 8 + datopotamab antibody PK
05
Payload

Payload & physicochemistry

Payload profile
Payload
DXd
Class
Topoisomerase I inhibitor
Mechanism
TopoI inhibitor
Released catabolite
DXd
Mechanistic subtype
TopoI
Stereochem / salt
-
Bystander
Yes
PAMPA rank
3
MW
493.5 Da
XLogP3
0
logD₇.₄
1.4
TPSA
129 Ų
pKa
9.2 pKa
Charge pH 7.4
+1
H-bond donors
3
H-bond acceptors
8
IC50 (HCEC)
-
Formula
C26H24FN3O6
PubChem CID
146160902
ADCdb payload
PAY0UXDSB
Hydrophobicity · logD₇.₄
hydrophilic −2+1.4+4 lipophilic
Bioactivity note
DXd is a potent DNA topoisomerase I (TOP1) inhibitor (literature IC50 ~0.3 uM cell-free TOP1; ADCdb lists therapeutic target DNA topoisomerase 1 / PATR0EGDKN). ADCdb ADC entry reports clinical efficacy (ORR ~24-39% across NSCLC/TNBC cohorts) but no ADC binding constant or payload
06
Dosing & regimen

Dosing

RP2D dose
6 mg/kg
Schedule
Q3W
Route
IV
Fractionated
No
n at RP2D
360
Dose basis
TBW
Trial phase
Approved
Dose-OAE available
No
Tox summary basis
RP2D
07
Ocular & expression

Ocular profile & eye-tissue target expression

Target profile
OAE any-grade
38 %
OAE grade 3+
3.4 %
OAE data status
reported
Severity (weighted)
13.8
Keratopathy
24 %
Conjunctival
-
Dry eye
27 %
Blurred vision
-
Dominant tissue
Ocular surface
Surface subtype
Corneal (off-target)
Grading scale
CTCAE v5
Reversibility
Reversible
Target expression in eye tissues (HCA detection · HPA bulk)
Cornea (central)
65.43 %
Cornea (limbal)
73.31 %
Conjunctiva
86.39 %
RPE
0 %
Retina (HPA)
0 nTPM
Cross-trial comparability · source-verified
Ascertainment: Systematic eye examsScale: CTCAE v5Denominator: RP2D
08
Identity & registry

Identifiers, registry & notes

ADC id
datopotamab-deruxtecan
Approval status
FDA-approved
Approval year
2025
UniProt
P09758
ADCdb ADC
DRG0ZOYQV
ADCdb antibody
ANI0WKJOW
ADCdb target
TAR0MIBZW
Primary source
DATROWAY HCP; TROPION-Breast01 JCO 2024
Aliases & development codes
Datroway; Dato-DXd; DS-1062
Notes
V3.1: OAE values corrected to DATROWAY label pooled values (36% any, 2.2% G3+; prev 51/1.9 was TROPION-Breast01-specific subset). Severity ratio 0.06 after correction. Retains surface-dominant pattern.