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Pinatuzumab vedotin Investigational DCDT2980S; anti-CD22-MMAE
RP2D dose
2.4 mg/kg Q3W RP2D
01 Multi-organ toxicity
Fingerprint & organ drill-down Any-grade Grade 3+
Ocular
9.5%
Hepatic
-
Neutrop.
27%
Thrombo.
-
Anemia
-
GI
43%
ILD
-
Neuro.
59%
Also reported Other · 18 · 5 systems
4 adverse-event terms
Ocular Toxicity Target expression Compare
sagittal schematic · Partial
↳ Tissues shaded by reported adverse-event rate.
Dominant tissue
Peripheral nervous system / bone marrow
Reported ocular events
Per-trial detail
Adverse events by trial ROMULUS (pinatuzumab+rituximab arm) · Phase 2 — 139 events, n=63 DCDT2980S Phase I (Advani) · Phase 1 — 10 events, n=16 DCDT2980S Phase I (Advani) · Phase 1 — 6 events, n=39 Advani phase I (NCT01209130) · Phase 1 — 6 events, n=39 DCDT2980S Ph1 (Advani 2017) · Phase 1 — 4 events, n=16 Unattributed cohort — 4 events DCDT2980S Phase I (Advani) · Phase 1 — 3 events, n=10 Unattributed cohort — 3 events Unattributed cohort — 3 events Unattributed cohort — 3 events Unattributed cohort — 3 events DCDT2980S Ph1 (Advani 2017) · Phase 1 — 2 events, n=39 Unattributed cohort — 2 events ROMULUS (NCT01691898) · Phase 2 — 1 event, n=42 ROMULUS (NCT01691898) · Phase 2 — 1 event, n=42 ROMULUS (NCT01691898) · Phase 2 — 1 event, n=21 ROMULUS (NCT01691898) · Phase 2 — 1 event, n=21 Advani phase I (NCT01209130) · Phase 1 — 1 event, n=16 Advani phase I (NCT01209130) · Phase 1 — 1 event, n=3 Unattributed cohort — 1 event Unattributed cohort — 1 event Unattributed cohort — 1 event Unattributed cohort — 1 event Unattributed cohort — 1 event Unattributed cohort — 1 event ROMULUS (pinatuzumab+rituximab arm) Phase 2 pinatuzumab vedotin 2.4 mg/kg + rituximab 375 mg/m2 q21d (pina/rituximab IV) n=63 CTCAE NR C to verify
CT.gov NCT01691898 all-cause mortality (derived G5; includes non-AE/PD deaths; crossover-inclusive) NCT01691898
139 adverse-event terms · 19 systems · expand a system below
Abdominal pain
17.5% G3+ 1.6%
Gastrooesophageal reflux disease
6.3%
Duodenal perforation
— G3+ 1.6%
Gastrointestinal haemorrhage
— G3+ 1.6%
Upper gastrointestinal haemorrhage
— G3+ 1.6%
Gastrointestinal pain
1.6%
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
anti-CD22 (pinatuzumab)
Epitope / domain
Binds CD22 epitope non-overlapping with epratuzumab
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. Advani CCR 2017 PMID 27601593 Ph1 N=75 R/R B-NHL Q3W: dose-proportional PK, no numeric clinical t½ in d in open-access tables
Mechanism
Tubulin inhibitor
Released catabolite
MMAE (unconjugated monomethyl auristatin E)
Mechanistic subtype
Tubulin-auristatin
Hydrophobicity · logD₇.₄
hydrophilic −2 +2.7 +4 lipophilic
Bioactivity note
ADCdb lists the MMAE payload's mechanistic target as Microtubule (MT); MMAE is a potent antimitotic tubulin-polymerization inhibitor. No numeric IC50 reported on the ADCdb ADC page or the PubChem MMAE record.
08 Ocular & expression
Ocular profile & eye-tissue target expression Target profile → Dominant tissue
Peripheral nervous system / bone marrow
Target expression in eye tissues (HCA detection · HPA bulk)
Cross-trial comparability · source-verified
Ascertainment: Symptom-driven reporting Scale: CTCAE v4 Denominator: RP2D ⚠ Not comparable: symptom-driven ascertainment
Dose & schedule → ocular toxicity · ocular AE (any-grade) by cohort
pinatuzumab vedotin 2.4 mg/kg + rituximab 375 mg/m2
q21d (pina/rituximab IV)
n=63 · ROMULUS (pinatuzumab+rituximab arm)
Per-cohort rates from the per-trial extraction, sorted by dose. Cross-trial comparison is subject to ascertainment / scale differences (see comparability above) — e.g. an early symptom-driven trial can read lower than a later systematic-exam trial at a higher dose.
Ocular AE grading reference — interspecialty consensus · 6 scales + dose modification 09 Identity & registry
Identifiers, registry & notes ADC id
pinatuzumab-vedotin
Approval status
Investigational
Primary source
Advani CCR 2017 PMID 27601593
Aliases & development codes
DCDT2980S; anti-CD22-MMAE
Notes
CD22 absent from cornea; 0% OAE verified in Advani 2017 CCR. V3.1: confirmed — paper has no ocular AEs; dominant toxicities are neutropenia and peripheral neuropathy.