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Disitamab vedotin Approved (ex-US) Aidixi; RC48; hertuzumab-vc-MMAE
Indication
HER2+ urothelial/gastric
Target family
Receptor tyrosine kinase
RP2D dose
2.0 mg/kg Q2W RP2D
01 Multi-organ toxicity
Fingerprint & organ drill-down Any-grade Grade 3+
Ocular
5%
Hepatic
42.1%
Neutrop.
42.1%
Thrombo.
24.3%
Anemia
21.5%
GI
29%
ILD
-
Neuro.
68.2%
Also reported Other · 14 · 6 systems
1 adverse-event term
Ocular Toxicity Target expression Compare
sagittal schematic · Reversible
↳ Tissues shaded by reported adverse-event rate.
Reported ocular events
Ocular AEs (increased lacrimation, blurred vision, periorbital swelling) -
Per-trial detail
Adverse events by trial Real-world mUTUC (Ng C 2025) · RWD (retrospective) — 44 events, n=198 Real-world G/GEJ (Shi Z 2025) · RWD (retrospective) — 32 events, n=38 RC48-C001/C003 (breast) · Phase 1/1b — 26 events, n=136 RC48+toripalimab ph1 (NCT04280341) · Phase 1 — 26 events, n=56 RC48-C009 · Phase 2 — 26 events, n=43 RC48-C005+C009 (pooled) · Phase 2 — 25 events, n=107 RC48-C001 (solid tumors) · Phase 1 — 23 events, n=57 Real-world G/GEJC (Yan X 2025) - combination · RWD (retrospective) — 20 events, n=36 Real-world G/GEJC (Yan X 2025) - monotherapy · RWD (retrospective) — 20 events, n=21 Real-world UC (Zhou T 2025) · RWD (retrospective) — 19 events, n=71 Neoadjuvant gastric RC48+camrelizumab+S-1 (Wang L 2025) · Phase 2 — 17 events, n=32 Unattributed cohort — 15 events Real-world neoadjuvant MIBC (Guo X 2025) · RWD (retrospective) — 12 events, n=25 RC48-C005 + RC48-C009 (combined) · Phase II — 11 events, n=107 Real-world mBC (Wang K 2025) · RWD (retrospective) — 10 events, n=89 Unattributed cohort — 2 events Unattributed cohort — 1 event Unattributed cohort — 1 event Unattributed cohort — 1 event Real-world mUTUC (Ng C 2025) RWD (retrospective) real-world RC48 + ICI not specified n=198 CTCAE 5.0 B to verify
Ng C, Cancer Immunol Immunother 2025 (real-world mUTUC + ICI) PMC12433416
44 adverse-event terms · 2 systems · expand a system below
Peripheral sensory neuropathy (sensory loss, numbness in hands and feet)
40.4% G3+ 9.1%
Decrease in appetite
7.6% G3+ 0%
Increased serum creatinine
6.6% G3+ 1.4%
Hypothyroidism
4.5% G3+ 0.5%
Increased triglycerides
1.5% G3+ 0%
Increased creatine kinase
1% G3+ 0.5%
Immune-mediated interstitial pneumonia
0.5% G3+ 0.5%
Intestinal obstruction
0.5% G3+ 0.5%
Altered consciousness
0.5% G3+ 0.5%
Elevated troponin
0.5% G3+ 0.5%
Pericardial effusion
0.5% G3+ 0.5%
Generalized pain
0.5% G3+ 0%
Urinary tract infection
0.5% G3+ 0%
02 Construct
Molecular anatomy Linker structure C28H40N6O7
[H]OC([H])([H])c1c([H])c([H])c(N([H])C(=O)[C@@]([H])(N([H])C(=O)[C@@]([H])(N([H])C(=O)C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])N2C(=O)C([H])=C([H])C2=O)C([H])(C([H])([H])[H])C([H])([H])[H])C([H])([H])C([H])([H])C([H])([H])N([H])C(=O)N([H])[H])c([H])c1[H] copy
Payload structure C39H67N5O7
CC[C@H](C)[C@@H]([C@@H](CC(=O)N1CCC[C@H]1[C@@H]([C@@H](C)C(=O)N[C@H](C)[C@H](C2=CC=CC=C2)O)OC)OC)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](C(C)C)NC copy
03 Antibody
Antibody & Fc engineering Antibody
disitamab (hertuzumab)
Linker
MC-vc-PAB (vedotin)
Attachment
Cysteine (interchain)
Conjugation
Conventional interchain Cys
DAR homogeneity
Heterogeneous
Cleavage trigger
Cathepsin B (Val-Cit)
Release control
Conditional
Stability note
Inherited from MC-vc-PAB conventional Cys class (Lyon 2014 retro-Michael; Alley 2008); Wang Cancer Commun 2024 PMC11260767 confirms linear PK Q2W with low free MMAE exposure but does not report numeric clinical t½ in the open-access version
Mechanism
Tubulin inhibitor
Released catabolite
MMAE (free monomethyl auristatin E)
Mechanistic subtype
Tubulin-auristatin
Hydrophobicity · logD₇.₄
hydrophilic −2 +2.7 +4 lipophilic
Bioactivity note
ADCdb: payload/ADC IC50 in HER2-expressing gastric cancer cell lines ~0.8-52.4 ug/mL (HER2-expression dependent). Clinical efficacy: ORR 24.8% in gastric cancer; 51.2% in urothelial cancer (NCT04264936). Source: ADCdb DRG0JEVIM.
08 Ocular & expression
Ocular profile & eye-tissue target expression Target profile → Target expression in eye tissues (HCA detection · HPA bulk)
Cross-trial comparability · source-verified
Ascertainment: Symptom-driven reporting Scale: Unknown Denominator: RP2D ⚠ Not comparable: symptom-driven ascertainment + grading scale not documented
Ocular AE grading reference — interspecialty consensus · 6 scales + dose modification 09 Identity & registry
Identifiers, registry & notes Approval status
Approved (ex-US)
Primary source
Sheng JCO 2021; NMPA label
Aliases & development codes
Aidixi; RC48; hertuzumab-vc-MMAE
Notes
Different antibody (hertuzumab) than trastuzumab-backbone ADCs → antibody-level confound. V3.1: rp2d corrected 2.5→2.0 mg/kg per Sheng JCO 2024.