ADC TOXICITY ATLAS
← Atlas

Rovalpituzumab tesirine

Discontinued
Rova-T; SC16LD6.5; SC-0002; SC0001-SCX; P256HB60FF; DrugBank DB13017
Sponsor
AbbVie (originally Stemcentrx)
Indication
DLL3+ small cell lung cancer (SCLC)
Target family
Notch ligand
RP2D dose
0.3 mg/kg
Q6W x2 cyclesRP2D
01
Multi-organ toxicity

Fingerprint & organ drill-down

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

Ocular

Any-grade
0.54%
G3+
1.4%
RP2D
sagittal schematic · Unknown

Tissues shaded by reported adverse-event rate.

Cornea
AE
-
Express.
-
Limbus
AE
-
Express.
-
Conjunctiva
AE
-
Express.
-
Lens
AE
-
Express.
-
Retina / RPE
AE
-
Express.
-
Dominant tissue
Periorbital/adnexa
Surface subtype
Mixed
Reversibility
Unknown
Reported ocular events
Vision blurred8.3%
n=12
Dry eye8.3%
n=12
Cataract8.3%
n=12
Retinopathy8.3%
n=12
Periorbital oedema6.7%
n=30
Periorbital swelling0.54%
n=368
Angle-closure glaucoma0.27%
n=368
Eyelid oedema0.27%
n=368
Cytomegalovirus chorioretinitis-
G3+ 0.27%
Eye disorders (any preferred term)0%
n=287
Photophobia-
G3+ 1.4%n=74
02
Construct

Molecular anatomy

Antibody
IgG1
Humanized
Linker
Cleavable
2
DAR
Payload
DNA cross-linker
Linker structureC41H65N5O15
[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])OC([H])([H])C([H])([H])OC([H])([H])C([H])([H])OC([H])([H])C([H])([H])OC([H])([H])C([H])([H])OC([H])([H])C([H])([H])OC([H])([H])C([H])([H])OC([H])([H])C([H])([H])OC([H])([H])C([H])([H])N([H])C(=O)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])[H])c([H])c1[H]
Payload structureC33H36N4O6
CC1=CN2[C@@H](C1)C=NC3=CC(=C(C=C3C2=O)OC)OCCCCCOC4=C(C=C5C(=C4)N=C[C@@H]6CC(=CN6C5=O)C)OC
03
Antibody

Antibody & Fc engineering

Antibody
Rovalpituzumab (SC16)
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
Mal-PEG8-Val-Ala-PABC (tesirine; SG3249)
Class
Cleavable
Cleavage
Cleavable
Attachment
Cysteine (interchain)
Conjugation
Conventional interchain Cys (maleimide; random cysteines)
Symmetry
Symmetric
DAR (mean)
2
DAR homogeneity
Heterogeneous
Plasma t½
-
Cleavage trigger
Cathepsin B (Val-Ala)
Release control
Conditional
Hydrophilicity mask
Discrete-PEG-spacer
Formula
C41H65N5O15
Linker MW
867.991 Da
Linker TPSA
247.85 Ų
Linker xLogP
-0.2829
ADCdb linker
LIN0YRUBS
In-vitro stability
-
05
Payload

Payload & physicochemistry

Payload profile
Payload
SG3199 (PBD dimer)
Class
PBD dimer
Mechanism
DNA cross-linker
Released catabolite
SG3199 (pyrrolobenzodiazepine [PBD] dimer)
Mechanistic subtype
DNA-crosslinker-PBD
Stereochem / salt
(11aS,11a'S)-configured PBD dimer (single defined stereoisomer); free base (no salt)
Bystander
Partial
PAMPA rank
-
MW
584.7 Da
XLogP3
2.8
logD₇.₄
2.5
TPSA
102 Ų
pKa
5 pKa
Charge pH 7.4
0
H-bond donors
0
H-bond acceptors
8
IC50 (HCEC)
-
Formula
C33H36N4O6
PubChem CID
90132565
ADCdb payload
PAY0LZRXU
Hydrophobicity · logD₇.₄
hydrophilic −2+2.5+4 lipophilic
Bioactivity note
SG3199 (free warhead) is a potent DNA minor-groove interstrand cross-linking PBD dimer with mean GI50 ~151.5 pM across a panel of human solid-tumor and hematological cell lines (Hartley et al., Sci Rep 2018). ADCdb reports clinical/efficacy data for the ADC: Phase 2 SCLC ORR 12.4
06
Dosing & regimen

Dosing

RP2D dose
0.3 mg/kg
Schedule
Q6W x2 cycles
Route
IV
Fractionated
No
n at RP2D
339
Dose basis
TBW
Trial phase
Phase 2
Dose-OAE available
No
Tox summary basis
RP2D
07
Ocular & expression

Ocular profile & eye-tissue target expression

Target profile
OAE any-grade
0.54 %
OAE grade 3+
1.4 %
OAE data status
reported
Severity (weighted)
1.14
Keratopathy
-
Conjunctival
-
Dry eye
-
Blurred vision
-
Dominant tissue
Periorbital/adnexa
Surface subtype
Mixed
Grading scale
CTCAE v4
Reversibility
Unknown
Target expression in eye tissues (HCA detection · HPA bulk)
Cornea (central)
-
Cornea (limbal)
-
Conjunctiva
-
RPE
-
Retina (HPA)
-
Cross-trial comparability · source-verified
Ascertainment: Systematic eye examsScale: CTCAE v4Denominator: RP2D
08
Identity & registry

Identifiers, registry & notes

ADC id
rovalpituzumab-tesirine
Approval status
Discontinued
Approval year
-
UniProt
Q9NYJ7
ADCdb ADC
DRG0ULCEQ
ADCdb antibody
ANI0NBQGD
ADCdb target
TAR0HELFC
Primary source
Morgensztern TRINITY Clin Cancer Res 2019 (PMID 31506387); Blackhall TAHOE & Johnson MERU JTO 2021 (PMIDs 34537440/33823285); Rudin Lancet Oncol 2017 (PMID 27932068); ADCdb DRG0ULCEQ
Aliases & development codes
Rova-T; SC16LD6.5; SC-0002; SC0001-SCX; P256HB60FF; DrugBank DB13017
Notes
DLL3-targeted PBD-dimer ADC (SC16 humanized IgG1 + tesirine [SG3249] Val-Ala/PEG8 maleimide linker + SG3199 PBD dimer payload, DAR 2). Sponsor AbbVie (originally Stemcentrx, acquired 2016). Never approved; orphan-drug designation only; entire program discontinued 2019 after the Phase 3 TAHOE (2L) and MERU (maintenance) trials failed for efficacy/futility. ADCdb lists DRG0ULCEQ; aliases include Rova-T, SC16LD6.5, SC-0002. NOTE a DISTINCT program "SC-002" (ADCdb DRG0UUEEH; Mansfield Lung Cancer 2020) exists and should not be conflated with Rova-T. DOMINANT (non-ocular) TOXICITIES = serosal-effusion/capillary-leak/edema syndrome + photosensitivity, NOT classic ADC ocular toxicity: pleural effusion TRINITY 32% (G3+ 5%)/MERU 26.6%/TAHOE ~28.6%; pericardial effusion TRINITY 15% (G3+ 4%)/MERU 16.8%/TAHOE ~19.9%; peripheral edema TRINITY 31% (G3+ 2%)/MERU 25.8%; photosensitivity reaction TRINITY 36% (G3+ 7%)/MERU 24.7%/TAHOE 16%; thrombocytopenia TRINITY 22% (G3+ 11%). These respiratory/serosal/dermatologic/edema PTs fall outside the schema's organ_system enum so are recorded here rather than as toxicity_rows. OCULAR (priority): monotherapy ocular toxicity is essentially absent at RP2D — TRINITY (n=339) reported 0 ocular AEs and TAHOE (n=287) reported 0 eye disorders in the MedDRA SOC; MERU (n=368) reported ONLY 3 serious eye AEs (periorbital swelling 2/368=0.54%, angle-closure glaucoma 1/368=0.27%, eyelid oedema 1/368=0.27%), most likely adnexal manifestations of the systemic edema syndrome rather than ocular-surface toxicity; Phase 1 (Rudin 2017) reported a single Grade 3 photophobia (1/74 SCLC). NO keratopathy/corneal or conjunctival signal in any monotherapy trial. The only meaningful ocular signal is in the COMBINATION trial NCT03026166 (Rova-T 0.3 mg/kg Q6W + nivolumab ± ipilimumab): vision blurred 3.3% (1/30 doublet) to 8.3% (1/12 triplet), and in the 12-patient triplet arm dry eye, cataract, retinopathy, xerophthalmia, eyelid oedema, periorbital oedema, ocular hyperaemia, eye pruritus and visual impairment each 8.3% (1/12) — all non-serious and heavily CONFOUNDED by checkpoint-inhibitor immune-related ocular AEs, so not cleanly attributable to Rova-T. ae_corneal/conjunctival/dry-eye/blurred-vision left blank for the ocular group because monotherapy reported none and sub-threshold (<5% non-serious) PTs are not tabulated. CTCAE v4.03 (confirmed Rudin 2017 & TRINITY). Linker physchem (LIN0YRUBS) identical to Loncastuximab tesirine (shared tesirine linker); SG3199 payload physchem are standard shared PBD-dimer values. No peripheral neuropathy reported (expected for a DNA-crosslinker PBD payload).