ADC TOXICITY ATLAS
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BAT-8006

Investigational
BAT8006; BAT-8006-001-CR; Folate Receptor-alpha-ADC; FRalpha-ADC
Sponsor
Bio-Thera Solutions, Ltd.
Indication
Platinum-resistant ovarian cancer (also fallopian tube / primary peritoneal; advanced solid tumors)
Target family
GPI-anchored
RP2D dose
84 mg/m2 (lower-toxicity optimization dose; 84 and 93 mg/m2 both carried forward, RP3D under determination)
Q3W (every 3 weeks)RP2D
01
Multi-organ toxicity

Fingerprint & organ drill-down

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

Ocular

Any-grade
0%
G3+
0%
RP2D
sagittal schematic · -

Tissues shaded by reported adverse-event rate.

Cornea
AE
0%
Express.
0.02%
Limbus
AE
-
Express.
0.07%
Conjunctiva
AE
-
Express.
0.19%
Lens
AE
-
Express.
-
Retina / RPE
AE
-
Express.
3.21%
0.4 nTPM
Dominant tissue
None
Surface subtype
None
Reversibility
-
Reported ocular events
Keratitis / uveitis / decreased vision (ocular toxicity, explicitly assessed)0%
02
Construct

Molecular anatomy

Antibody
Humanized
Linker
Cleavable
7
DAR
Payload
DNA topoisomerase I (TOP1) inhibitor; membrane-permeable, strong bystander effect
Linker structure
structure not applicable
Payload structureC24H22FN3O4
CC[C@@]1(C2=C(COC1=O)C(=O)N3CC4=C5[C@H](CCC6=C5C(=CC(=C6C)F)N=C4C3=C2)N)O
03
Antibody

Antibody & Fc engineering

Antibody
Humanized anti-folate receptor alpha (anti-FRalpha) monoclonal antibody (undisclosed)
Isotype
-
Origin
Humanized
Fc modifications
-
Glycoengineering
-
Effector silencing
-
FcγR binding
Retained
C1q binding
Retained
04
Linker & conjugation

Linker chemistry

Linker profile
Linker
Proprietary systemically-stable cleavable linker (Bio-Thera next-gen ADC platform)
Class
Cleavable
Cleavage
Cleavable
Attachment
-
Conjugation
-
Symmetry
-
DAR (mean)
7
DAR homogeneity
-
Plasma t½
-
Cleavage trigger
Cleavable linker (intracellular/enzymatic); highly systemically stable per sponsor
Release control
Conditional
Hydrophilicity mask
Unknown
Formula
-
Linker MW
-
Linker TPSA
-
Linker xLogP
-
ADCdb linker
-
In-vitro stability
-
05
Payload

Payload & physicochemistry

Payload profile
Payload
Exatecan
Class
Topoisomerase I inhibitor
Mechanism
DNA topoisomerase I (TOP1) inhibitor; membrane-permeable, strong bystander effect
Released catabolite
Exatecan (TOP1 inhibitor; membrane-permeable bystander payload)
Mechanistic subtype
TopoI
Stereochem / salt
-
Bystander
Yes
PAMPA rank
-
MW
435.4 Da
XLogP3
0.4
logD₇.₄
-
TPSA
106 Ų
pKa
-
Charge pH 7.4
0
H-bond donors
2
H-bond acceptors
7
IC50 (HCEC)
-
Formula
C24H22FN3O4
PubChem CID
151115
ADCdb payload
PAY0LEIGJ
Bioactivity note
Exatecan free payload (topoisomerase I inhibitor; ADCdb payload PAY0LEIGJ) in vitro IC50: MOLT-4 0.16 nM; CCRF-CEM 0.25 nM; DU145 0.49 nM; DMS 114 0.58 nM. Molecular target: DNA topoisomerase 1 (TOP1). Source: ADCdb payload page PAY0LEIGJ.
06
Dosing & regimen

Dosing

RP2D dose
84 mg/m2 (lower-toxicity optimization dose; 84 and 93 mg/m2 both carried forward, RP3D under determination)
Schedule
Q3W (every 3 weeks)
Route
IV
Fractionated
No
n at RP2D
87
Dose basis
BSA
Trial phase
Phase 1/2
Dose-OAE available
No
Tox summary basis
RP2D
07
Ocular & expression

Ocular profile & eye-tissue target expression

Target profile
OAE any-grade
0 %
OAE grade 3+
0 %
OAE data status
documented-absent
Severity (weighted)
0
Keratopathy
0 %
Conjunctival
-
Dry eye
-
Blurred vision
0 %
Dominant tissue
None
Surface subtype
None
Grading scale
CTCAE (unversioned)
Reversibility
-
Target expression in eye tissues (HCA detection · HPA bulk)
Cornea (central)
0.02 %
Cornea (limbal)
0.07 %
Conjunctiva
0.19 %
RPE
3.21 %
Retina (HPA)
0.4 nTPM
Cross-trial comparability
Ascertainment: Symptom-driven reportingScale: CTCAE (unversioned)Denominator: RP2D⚠ OAE rate not directly comparable across trials
08
Identity & registry

Identifiers, registry & notes

ADC id
bat-8006
Approval status
Investigational
Approval year
-
UniProt
P15328
ADCdb ADC
DRG0EGQMP
ADCdb antibody
-
ADCdb target
TAR0QHAVI
Primary source
Bio-Thera BAT8006 Ph1/2 (ASCO 2024 #5550 + ASCO 2025 #5517 PROC update); NCT05378737
Aliases & development codes
BAT8006; BAT-8006-001-CR; Folate Receptor-alpha-ADC; FRalpha-ADC
Notes
Built from three sources per the contract. (1) ADCdb DRG0EGQMP: target FOLR1 (TAR0QHAVI), payload exatecan (PAY0LEIGJ, TOP1 inhibitor), DAR "7 to 8", sponsor Bio-Thera, Phase 1/2, NCT05378737; ADCdb does NOT disclose antibody name, isotype, linker name/class/attachment, conjugation, or a linker LIN cross-ref (all left blank). (2) Clinical: ASCO 2024 abstract #5550 (J Clin Oncol 42:16_suppl 5550) + Bio-Thera/PRNewswire press release, and the ASCO 2025 #5517 poster (PROC dose-optimization update, BAT-8006-001-CR, data cut 2025-04-30) which provides the cleanest >=Grade 3 TEAE table by dose cohort. Dosing is IV Q3W at two optimization doses 84 and 93 mg/m2 (BSA-based); 84 mg/m2 (n=87) selected as the better-tolerated, RP3D-aligned cohort and tagged RP2D/line_context=RP2D. The 93 mg/m2 comparator rates are noted per-row. (3) PubChem CID 151115 (exatecan): MW 435.4, XLogP3 0.4, TPSA 106, C24H22FN3O4; bystander = Yes (membrane-permeable). OCULAR: triage explicit-zero confirmed and reinforced by a second independent readout — ASCO 2024 'no ILD/pneumonitis and keratitis, uveitis, decreased vision was reported' and ASCO 2025 conclusion 'no ILD/ocular toxicity was reported.' oae_any_pct set to 0 with documented note; ocular_surface_subtype=None. This is a valuable negative/control case because FRalpha is the mirvetuximab soravtansine (DM4) target which carries high corneal keratopathy, whereas the exatecan (TOP1) payload here shows no ocular signal. CAVEATS: any-grade TRAE rates (anemia 82%, leukopenia 80%, neutropenia 77%, vomiting 67%, nausea 60%, thrombocytopenia 55%) come from the ASCO 2024 abstract summary (tier C); the granular >=G3 by-dose figures are tier B from the 2025 poster. Linker is described only as 'proprietary systemically-stable cleavable linker' — class=Cleavable but no enzyme specificity, attachment chemistry, or LIN id is public, so adcdb linker fields and conjugation_method are blank. Not filling derived columns per instructions.