ADC TOXICITY ATLAS
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BRY-812

Investigational
BRY812
Sponsor
BioRay Biopharmaceutical Co., Ltd. (a.k.a. BioRay Pharmaceutical Co., Ltd.)
Indication
Advanced solid tumors (predominantly breast cancer)
Target family
Receptor tyrosine kinase
RP2D dose
-
Q3W (every 3 weeks, Day 1 of 21-day cycle)RP2D
01
Multi-organ toxicity

Fingerprint & organ drill-down

0%severity100%
0
Assessed · clear
true 0%
No data
never assessed
1 adverse-event term

Ocular

Any-grade
5.9%
G3+
-
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
Cornea
Surface subtype
Corneal (off-target)
Reversibility
Unknown
Reported ocular events
Corneal injury5.9%
n=2
02
Construct

Molecular anatomy

Antibody
IgG1
Humanized
Linker
Other
Cleavable
DAR
Payload
Monomethyl auristatin E (MMAE)
Microtubule inhibitor (tubulin polymerization inhibitor; antimitotic)
Linker structure
structure not applicable
Payload structureC39H67N5O7
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
03
Antibody

Antibody & Fc engineering

Antibody
Undisclosed (anti-LIV-1 humanized IgG1)
Isotype
IgG1
Origin
Humanized
Fc modifications
-
Glycoengineering
-
Effector silencing
-
FcγR binding
Retained
C1q binding
Retained
04
Linker & conjugation

Linker chemistry

Linker profile
Linker
Undisclosed (proprietary)
Class
Other
Cleavage
Cleavable
Attachment
Cysteine (interchain)
Conjugation
CysLink (proprietary irreversible chemical/cysteine conjugation; reduces premature payload deconjugation/exchange)
Symmetry
Symmetric
DAR (mean)
-
DAR homogeneity
-
Plasma t½
-
Cleavage trigger
-
Release control
N/A
Hydrophilicity mask
Unknown
Formula
-
Linker MW
-
Linker TPSA
-
Linker xLogP
-
ADCdb linker
-
In-vitro stability
-
05
Payload

Payload & physicochemistry

Payload profile
Payload
Monomethyl auristatin E (MMAE)
Class
Auristatin
Mechanism
Microtubule inhibitor (tubulin polymerization inhibitor; antimitotic)
Released catabolite
MMAE (free monomethyl auristatin E)
Mechanistic subtype
Tubulin-auristatin
Stereochem / salt
-
Bystander
Yes
PAMPA rank
-
MW
717.99 Da
XLogP3
4.1
logD₇.₄
-
TPSA
150 Ų
pKa
-
Charge pH 7.4
+1
H-bond donors
4
H-bond acceptors
8
IC50 (HCEC)
-
Formula
C39H67N5O7
PubChem CID
11542188
ADCdb payload
PAY0FSXOW
06
Dosing & regimen

Dosing

RP2D dose
-
Schedule
Q3W (every 3 weeks, Day 1 of 21-day cycle)
Route
IV
Fractionated
No
n at RP2D
-
Dose basis
-
Trial phase
Phase 1
Dose-OAE available
Yes
Tox summary basis
-
07
Ocular & expression

Ocular profile & eye-tissue target expression

Target profile
OAE any-grade
5.9 %
OAE grade 3+
-
OAE data status
reported
Severity (weighted)
-
Keratopathy
-
Conjunctival
-
Dry eye
-
Blurred vision
-
Dominant tissue
Cornea
Surface subtype
Corneal (off-target)
Grading scale
CTCAE (unversioned)
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: Symptom-driven reportingScale: CTCAE (unversioned)Denominator: RP2D⚠ OAE rate not directly comparable across trials
08
Identity & registry

Identifiers, registry & notes

ADC id
bry-812
Approval status
Investigational
Approval year
-
UniProt
Q13433
ADCdb ADC
DRG0YLNPN
ADCdb antibody
-
ADCdb target
TAR0CHCZT
Primary source
ASCO 2025 abstract 3021 (BRY812 Phase 1; J Clin Oncol 2025;43:16_suppl:3021)
Aliases & development codes
BRY812
Notes
BRY-812 (BRY812) = BioRay's anti-LIV-1 (SLC39A6/ZIP6) humanized IgG1 MMAE ADC built on the proprietary CysLink irreversible conjugation platform. Antibody name, linker identity, linker class/cleavage chemistry, and DAR are all UNDISCLOSED (ADCdb lists them as "Undisclosed"); isotype (humanized IgG1) and conjugation method (CysLink) come from AACR 2024 abstract 1886. ADCdb cross-refs: DRG0YLNPN (ADC), TAR0CHCZT (target LIV-1), PAY0FSXOW (MMAE payload), PATR0CXRBX (microtubule). Trial NCT06038058 (Phase Ia dose escalation + expansion); a Phase 2a (NCT07311538) is planned/initiated. CLINICAL EVIDENCE = SINGLE CONFERENCE ABSTRACT (tier D throughout): ASCO 2025 abstract 3021 (JCO 2025;43:16_suppl). Phase Ia escalated 7 dose levels (0.25, 0.5, 1.0, 2.0, 2.8, 3.6, 4.4 mg/kg) Q3W IV (accelerated titration then mTPI-2); expansion at 2.0/2.8/3.6 mg/kg. 4.4 mg/kg NOT tolerated (DLTs; G4 neutropenia 4/4). RP2D not formally declared (further optimization in Phase Ib) - so rp2d_dose left blank; the 3.6 mg/kg expansion row is tagged line_context=RP2D as the best primary-cohort proxy. OCULAR (reason for inclusion): the abstract reports 2 corneal injuries, each leading to treatment discontinuation (one at 3.6 mg/kg, one at 4.4 mg/kg), as part of "4 patients discontinued due to AEs (2 corneal injury, 1 peripheral neuropathy [2.8 mg/kg], 1 hepatic enzyme increase [3.6 mg/kg])." These are DISCONTINUATION-ATTRIBUTED COUNTS, not overall incidence rates, and the safety-population denominator is not separately stated. Percentages for corneal injury (5.9%), PN (2.9%), and hepatic (2.9%) are DERIVED as count/34 using the efficacy-evaluable population (N=34) and therefore understate true any-grade incidence; grades are unspecified. Corneal injury is the classic MMAE-class off-target ocular-surface toxicity -> ocular_surface_subtype = Corneal (off-target). OTHER TOX: most common grade >=3 TEAE = neutropenia (G4 2/12 at 3.6 mg/kg; 4/4 at 4.4 mg/kg). No thrombocytopenia, anemia, GI, pulmonary, or infusion-reaction rates were reported in the abstract, so those rows are left empty (blank = not in literature). EFFICACY (context): ORR 23.5% (8/34 PR), 7/34 SD, DCR 44.1%; in LIV-1/PS2+-enriched breast cancer ORR 43% (6/14). PAYLOAD PHYSCHEM (MMAE, PubChem CID 11542188, release 2025.09.15): MW 717.99 (formula C39H67N5O7), XLogP3 4.1, TPSA 150 A^2, HBD 4, HBA 8, rotatable bonds 20, bystander-active. logD7.4 and pKa left blank (not PubChem-computed / not confidently sourced); charge inferred +1 from the basic secondary amine. ADCdb lists xLogP 3.53 / TPSA 149.54 (alt calc); PubChem values used per DB convention. SOURCE-ACCESS NOTE: ascopubs.org and aacrjournals.org returned HTTP 403 to direct fetch; clinical content above was extracted via search-engine renderings of the JCO/AACR abstracts plus ADCdb, Synapse/Patsnap, and ADC Review. ClinicalTrials.gov API gave trial design (Phase 1, Q3W IV, est. enrollment 164, MTD/RP2D/DLT as primary outcomes) but no posted results.