Camidanlumab tesirine

Discontinued^silent

ADCT-301; Cami; HuMax-TAC-ADC

Target

CD25 (IL-2 receptor subunit alpha / IL2RA) · IL2RA

Sponsor

ADC Therapeutics

Indication

CD25+ relapsed/refractory classic Hodgkin lymphoma (also Ph1 NHL & solid tumors)^silent

Target family

Cytokine receptor^silent

RP2D dose

0.045 mg/kg x2 then 0.03 mg/kg (45 ug/kg -> 30 ug/kg)

Q3W (21-day cycles); 45 ug/kg cycles 1-2 then 30 ug/kg for up to ~1 yearRP2D

Multi-organ toxicity

Fingerprint & organ drill-down

Also reported

0%severity100%

Assessed · clear

true 0%

No data

never assessed

16 adverse-event terms

Ocular

Any-grade

0.9%

G3+

RP2D

sagittal schematic · Reversible

↳

Tissues shaded by reported adverse-event rate.

Cornea

Express.

Limbus

Express.

Conjunctiva

Express.

Lens

Express.

Retina / RPE

Express.

Dominant tissue

Periorbital/adnexa

Surface subtype

Unknown

Reversibility

Reversible

Reported ocular events

Vision Blurred5.71%

non-seriousn=35

Lacrimation increased5.26%

non-seriousn=133

Vision blurred5.13%

non-seriousn=78

Dry eye3.85%

non-seriousn=78

Dry Eye2.86%

non-seriousn=35

Eye Pain2.86%

non-seriousn=35

Ocular Hyperaemia2.86%

non-seriousn=35

Pupillary Reflex Impaired2.86%

non-seriousn=35

Diplopia1.5%

non-seriousn=133

Periorbital oedema1.28%

non-seriousn=78

Eye discharge1.28%

non-seriousn=78

Eyelid oedema1.28%

non-seriousn=78

Blepharitis0.9%

n=78

Conjunctival haemorrhage0.75%

non-seriousn=133

Photophobia0.75%

non-seriousn=133

Eye disorders, grade >=3 (any)0%

G3+

Per-trial detail

Adverse events by trial

Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-HodgkiPHASE1real-worldn=133CTCAE NR (ClinicalTrials.govPooledC

ClinicalTrials.gov NCT02432235 posted results, adverse events module (non-serious; 26/133 pooled across arms)

235 adverse-event terms · 22 systems · expand a system below

Infections29

Upper respiratory tract infection

7.52%non-serious

10/133

Oral candidiasis

4.51%non-serious

6/133

Candida infection

3.76%non-serious

5/133

Lung infection

3.01%serious

4/133

Pneumocystis jirovecii pneumonia

3.01%serious

4/133

Sinusitis

3.01%non-serious

4/133

Urinary tract infection

3.01%non-serious

4/133

Cellulitis

2.26%non-serious

3/133

Influenza

2.26%non-serious

3/133

Neutropenic sepsis

2.26%serious

3/133

Oral herpes

2.26%non-serious

3/133

Pharyngitis

2.26%non-serious

3/133

Pneumonia

2.26%non-serious

3/133

Rhinovirus infection

2.26%serious

3/133

Sepsis

2.26%serious

3/133

Skin infection

2.26%non-serious

3/133

Clostridium difficile colitis

1.5%serious

2/133

Clostridium difficile infection

1.5%non-serious

2/133

Rash pustular

1.5%serious

2/133

Arthritis bacterial

0.75%serious

1/133

Arthritis infective

0.75%non-serious

1/133

Aspergillus infection

0.75%non-serious

1/133

Bacteraemia

0.75%serious

1/133

Herpes simplex

0.75%non-serious

1/133

Herpes virus infection

0.75%serious

1/133

Respiratory syncytial virus infection

0.75%serious

1/133

Soft tissue infection

0.75%serious

1/133

Vaginal infection

0.75%non-serious

1/133

Wound infection

0.75%serious

1/133

GI23

Dermatologic22

Neurologic (other)20

General19

Investigations19

Pulmonary16

Metabolic15

Musculoskeletal12

Cardiac10

Hematologic8

Injury7

Ocular7

Lacrimation increased

5.26%non-serious

7/133

Vision blurred

4.51%non-serious

6/133

Dry eye

3.76%non-serious

5/133

Periorbital oedema

3.01%non-serious

4/133

Diplopia

1.5%non-serious

2/133

Conjunctival haemorrhage

0.75%non-serious

1/133

Photophobia

0.75%non-serious

1/133

Vascular7

Psychiatric6

Other4

Endocrine3

Neoplasms3

Renal2

Ear1

Hepatic1

Immune1

Construct

Molecular anatomy

Antibody

IgG1

Human

Linker

Cleavable

2.3

DAR

Payload

SG3199 (PBD dimer)

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

Antibody

Antibody & Fc engineering

Antibody

Camidanlumab (HuMax-TAC)

Isotype

IgG1

Origin

Human

Fc modifications

None^inferred

Glycoengineering

Standard^inferred

Effector silencing

None (unmodified human IgG1 Fc; effector function retained)

FcγR binding

Retained

C1q binding

Retained^inferred

Linker & conjugation

Linker chemistry

Linker profile

Linker

VA dipeptide (tesirine) [Mal-PEG8-Val-Ala-PABC]

Class

Cleavable

Cleavage

Cleavable

Attachment

Cysteine (interchain)

Conjugation

Conventional interchain Cys (stochastic)

Symmetry

Symmetric

DAR (mean)

2.3

DAR homogeneity

Heterogeneous

Plasma t½

2.3 d

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 Å²

Linker xLogP

-0.2829

ADCdb linker

LIN0YRUBS

In-vitro stability

Payload

Payload & physicochemistry

Payload profile

Payload

SG3199 (PBD dimer)

Class

PBD dimer

Mechanism

DNA cross-linker

Released catabolite

SG3199 (pyrrolobenzodiazepine [PBD] dimer; DNA interstrand cross-linker)

Mechanistic subtype

DNA-crosslinker-PBD

Stereochem / salt

(11aS,11a'S)-configured PBD dimer (single defined stereoisomer); free base (no salt)

Bystander

Partial

PAMPA rank

584.7 Da

XLogP3

2.8

logD₇.₄

2.5

TPSA

102 Å²

pKa

5 pKa

Charge pH 7.4

H-bond donors

H-bond acceptors

IC50 (HCEC)

Formula

C33H36N4O6

PubChem CID

90132565

ADCdb payload

PAY0LZRXU

Potency IC50 (nM)

0.1515

Hydrophobicity · logD₇.₄

hydrophilic −2+2.5+4 lipophilic

Bioactivity note

ADCdb (DRG0FUFBP) reports in vitro GI50: 0.26 pM (EoL-1), 4.96 pM (SU-DHL-1), 17.07 pM (Karpas-299); in vivo up to 98.8% TGI at 0.6 mg/kg; clinical 48.6% CR in classical Hodgkin lymphoma at 45 ug/kg. Payload SG3199 is a highly potent PBD-dimer DNA interstrand crosslinker (the imi

Dosing & regimen

Dosing

RP2D dose

0.045 mg/kg x2 then 0.03 mg/kg (45 ug/kg -> 30 ug/kg)

Schedule

Q3W (21-day cycles); 45 ug/kg cycles 1-2 then 30 ug/kg for up to ~1 year

Route

Fractionated

n at RP2D

117

Dose basis

TBW

Trial phase

Phase 2

Dose-OAE available

Tox summary basis

RP2D

ADA rate (%)

0 %

Ocular & expression

Ocular profile & eye-tissue target expression

Target profile

OAE any-grade

0.9 %

OAE grade 3+

0 %

OAE data status

reported

Severity (weighted)

0.27

Keratopathy

Conjunctival

Dry eye

Blurred vision

Dominant tissue

Periorbital/adnexa

Surface subtype

Unknown

Grading scale

CTCAE v4.0

Reversibility

Reversible

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: UnknownDenominator: RP2D⚠ Not comparable: symptom-driven ascertainment + grading scale not documented

Dose & schedule → ocular toxicity · ocular AE (any-grade) by cohort

60 µg/kg + pembrolizumab 200 mg

Q3W

33.3%

n=9 · ADCT-301 Ph1 solid tumors

30 µg/kg + pembrolizumab 200 mg

Q3W

25%

n=4 · ADCT-301 Ph1 solid tumors

45 µg/kg + pembrolizumab 200 mg

Q3W

10%

n=10 · ADCT-301 Ph1 solid tumors

5 µg/kg

Q3W

50%

n=2 · ADCT-301 Ph1 R/R HL+NHL

37.5 µg/kg

Weekly (D1,8,15)

33.3%

n=3 · ADCT-301 Ph1 R/R AML/ALL

72 µg/kg

Q3W

33.3%

n=3 · ADCT-301 Ph1 R/R AML/ALL

100 µg/kg

Q3W

33.3%

n=3 · ADCT-301 Ph1 R/R HL+NHL

22 µg/kg

Q3W

33.3%

n=3 · ADCT-301 Ph1 R/R AML/ALL

30 µg/kg

Q3W

20%

n=5 · ADCT-301 Ph1 solid tumors

30 µg/kg

Weekly (D1,8,15)

16.7%

n=6 · ADCT-301 Ph1 R/R AML/ALL

100 µg/kg

Q3W

14.3%

n=7 · ADCT-301 Ph1 solid tumors

60 µg/kg

Q3W

13.8%

n=29 · ADCT-301 Ph1 R/R HL+NHL

125 µg/kg

Q3W

12.5%

n=8 · ADCT-301 Ph1 solid tumors

80 µg/kg

Q3W

12.5%

n=8 · ADCT-301 Ph1 solid tumors

30 µg/kg

Q3W

10%

n=20 · ADCT-301 Ph1 R/R HL+NHL

—

5.71%

n=35 · Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myelo

—

5.26%

n=133 · Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgki

—

5.13%

n=78 · Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

45 µg/kg

Q3W

4.9%

n=41 · ADCT-301 Ph1 R/R HL+NHL

45 ug/kg Q3W x2 then 30 ug/kg

Q3W

0.9%

· ADCT-301-201

—

· ADCT-301-201

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

Identity & registry

Identifiers, registry & notes

ADC id

camidanlumab-tesirine

Approval status

Discontinued^silent

Approval year

UniProt

P01589

ADCdb ADC

DRG0FUFBP

ADCdb antibody

ANI0WWODM

ADCdb target

TAR0CYSHF

Primary source

Blood Adv 2025;9(23):6205 (PMID 40811783) — pivotal Ph2 cHL (ADCT-301-201 / NCT04052997, N=117); Hamadani Lancet Haematol 2021;8(6):e433 (PMID 34048682) — Ph1; ADCdb DRG0FUFBP

Aliases & development codes

ADCT-301; Cami; HuMax-TAC-ADC

Notes

Anti-CD25 (IL2RA) PBD-dimer ADC from ADC Therapeutics (HuMax-TAC human IgG1, stochastic interchain-Cys conjugation, DAR 2.3; ADCdb lists 2.25). Uses the SAME tesirine linker (Mal-PEG8-Val-Ala-PABC, ADCdb LIN0YRUBS) and SG3199 PBD-dimer payload as loncastuximab tesirine, so linker physchem and chemistry-input fields were carried from that verified row. MECHANISM is Treg-depleting / CD25-targeted. OCULAR (priority, why it qualifies): MINIMAL signal. In the pivotal Ph2 cHL study (ADCT-301-201 / NCT04052997, N=117 at RP2D 45 ug/kg Q3W x2 then 30 ug/kg), the ONLY eye-disorder AE was a single grade 1 blepharitis = 1/117 (0.9%); no corneal/conjunctival/dry-eye/blurred-vision/keratitis events and no grade >=3 ocular. Consistent with the PBD class (cf. loncastuximab/vadastuximab = ~0% OAE). ocular_surface_subtype set to 'Unknown' because blepharitis is an eyelid/adnexal event that does not map to the corneal/conjunctival/visual surface categories; the four specific surface-PT columns left blank (not separately reported) while oae_any=0.9 and oae_g3plus=0 are documented. DOMINANT toxicities are NOT ocular: skin/cutaneous 78.6% (G3+ 22.2%; maculopapular rash 32.5%, G3+ 6.8%) and immune-related GBS/polyradiculopathy 8/117 (6.8%; 5 grade >=3) — the latter is the AESI that led the FDA to require a much larger safety trial and the program to be paused/discontinued. NOTE: skin is not an organ_system in the toxicity_rows enum, so the dominant skin toxicity is recorded here rather than as a row. Other: fatigue 38.5%, hepatic enzyme rises (GGT 17.1%; 2 grade-3 DILI), cytopenias (lymphopenia G3+ 10.3% highest), nausea 27.4%, pneumonitis 3.4% + 1 grade-3 ILD, IRR 4.3% (all G1-2). 28.2% discontinued for TEAEs; ORR 70.1%, CR 33.3%. CTCAE version not stated in the Ph2 report (AEs coded with MedDRA v22.0), so ae_grading_scale left blank. Payload_physchem are standard shared SG3199 values. Clinical tier B (peer-reviewed primary); composition tier B (peer-reviewed + ADCdb); chemistry/payload tier C (derived from shared tesirine linker/SG3199 class).