ADC ID	DRG0FUFBP
ADC Name	Camidanlumab tesirine
Synonyms	camidanlumab tesirine; ADCT-301; HuMax-TAC-ADC    Click to Show/Hide
Organization	ADC Therapeutics (Originator);Spirogen (Top20 MNC) (Originator) (No Rights);Genmab (No Rights)
Drug Status	Phase 2 (discontinued)
Drug-to-Antibody Ratio	2.25~2.3
Structure
				2D MOL
Antibody Name	Camidanlumab					Antibody Info
Antigen Name	Interleukin-2 receptor subunit alpha (IL2RA)					Antigen Info
Payload Name	SG3199 (SC-DR002)					Payload Info
Therapeutic Target	Human deoxyribonucleic acid (hDNA)					Target Info
Linker Name	Mal-PEG8-Val-Ala-PABC					Linker Info
Conjugate Type	Random Cysteines
Combination Type	tesirine

Incubation Time	7.3days	Release	50%	Reference	[1]
Incubation Medium	mice serum
Description	In mice serum, the half-lives of the naked antibody HuMax-Tac and camidanlumab tesirine were the same, both were 7.3 days

Dissocation Constant (Kd)	Binding Target	Description	Reference
Undisclosed	CD25	ADCT-301 showed strong binding affinity to CD25-positive human anaplastic large cell lymphoma-derived cell lines Karpas 299 and Su-DHL-1	[1]

Standard Type	Value	Units	Description	Reference
Maximum Observed Concentration (Cmax)	648	ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1.	[2]
Area Under the Concentration-Time Curve (AUC)	1846	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1, AUCinf.	[2]
Maximum Observed Concentration (Cmax)	808	ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2.	[2]
Area Under the Concentration-Time Curve (AUC)	2183	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2, AUCinf.	[2]
Maximum Observed Concentration (Cmax)	716.4	ng/mL	Summary of exposures by occurrence of ORR at cycle 2, Non-responders.	[3]
Maximum Observed Concentration (Cmax)	796.8	ng/mL	Summary of exposures by occurrence of ORR at cycle 2, Responders.	[3]
Maximum Observed Concentration (Cmax)	748.6	ng/mL	Summary of exposures by occurrence of ORR at cycle 2, Overall.	[3]
Maximum Observed Concentration (Cmax)	501	ng/mL	Summary of exposures by occurrence of OS at cycle 2, Non-resonders.	[3]
Maximum Observed Concentration (Cmax)	760.9	ng/mL	Summary of exposures by occurrence of OS at cycle 2, Resonders.	[3]
Maximum Observed Concentration (Cmax)	748.6	ng/mL	Summary of exposures by occurrence of OS at cycle 2, Overall.	[3]
Maximum Observed Concentration (Cmax)	722.5	ng/mL	Summary of exposures by occurrence of increased GGT at cycle 2, no.	[3]
Maximum Observed Concentration (Cmax)	931.5	ng/mL	Summary of exposures by occurrence of increased GGT at cycle 2, yes.	[3]
Maximum Observed Concentration (Cmax)	741.8	ng/mL	Summary of exposures by occurrence of increased GGT at cycle 2, overall.	[3]
Maximum Observed Concentration (Cmax)	741.3	ng/mL	Summary of exposures by occurrence of neurologic AEs at cycle 2, no.	[3]
Maximum Observed Concentration (Cmax)	757	ng/mL	Summary of exposures by occurrence of neurologic AEs at cycle 2, yes.	[3]
Maximum Observed Concentration (Cmax)	741.8	ng/mL	Summary of exposures by occurrence of neurologic AEs at cycle 2, overall.	[3]
Maximum Observed Concentration (Cmax)	748.4	ng/mL	Summary of exposures by occurrence of autoimmune AEs at cycle 2, no.	[3]
Maximum Observed Concentration (Cmax)	576.5	ng/mL	Summary of exposures by occurrence of autoimmune AEs at cycle 2, yes.	[3]
Maximum Observed Concentration (Cmax)	741.8	ng/mL	Summary of exposures by occurrence of autoimmune AEs at cycle 2, overall.	[3]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	1846	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1, AUCinf.	[2]
Volume of Distribution (Vd)	5.08	L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1.	[2]
Area Under the Concentration-Time Curve (AUC)	2183	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2, AUCinf.	[2]
Volume of Distribution (Vd)	4.91	L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2.	[2]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	1846	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1, AUCinf.	[2]
Area Under the Concentration-Time Curve (AUC)	2183	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2, AUCinf.	[2]

Standard Type	Value	Units	Description	Reference
Elimination Half-Life (t1/2)	7.3	days	In mice serum, the half-lives of the naked antibody HuMax-Tac and camidanlumab tesirine were the same, both were 7.3 days	[1]
Clearance (CL)	1.68	L/day	Based on phase 1 trial data, increased pharmacokinetic exposure was dose-dependent, and the mean apparent clearance (1.68 L/day) showed moderate to marked interpatient variability	[1]
Area Under the Concentration-Time Curve (AUC)	1846	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1, AUCinf.	[2]
Elimination Half-Life (t1/2)	2.31	day	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1.	[2]
Clearance (CL)	1,68	L/day	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 1.	[2]
Area Under the Concentration-Time Curve (AUC)	2183	day*ug/L	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2, AUCinf.	[2]
Elimination Half-Life (t1/2)	2.69	day	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2.	[2]
Clearance (CL)	1.37	L/day	Summary of camidanlumab tesirine PK parameters in serum following the 45 ug/kg dose Q3W for the total study population, Cycle 2.	[2]

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
Progression Free Survival	NCT04052997	PHASE2	A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Overall response (OR)	NCT02432235	PHASE1	A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients With Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma    Click to Show/Hide
Objective Response Rate (ORR)	NCT03621982	PHASE1	A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors    Click to Show/Hide
Disease control rate (DCR)	NCT03621982	PHASE1	A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors    Click to Show/Hide
Undisclosed	NCT04639024	PHASE2	An Open-label Pilot Study to Evaluate the Safety and Efficacy of ADCT-301 in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Myeloproliferative Neoplasms.
Undisclosed	NCT02588092	PHASE1	A Phase 1, Open-label, Dose-escalation, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Activity of ADCT 301 in Patients With Relapsed or Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia    Click to Show/Hide
Complete Remission (CR)	NCT02432235	Phase 1	A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.    Click to Show/Hide
Undisclosed	NCT02588092	Phase 1	A phase 1, open-label, dose-escalation, multicenter study to evaluate the tolerability, safety, pharmacokinetics, and activity of ADCT 301 in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) or CD25-positive acute lymphoblastic leukemia.    Click to Show/Hide
Undisclosed	NCT02432235	Phase 1	A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.    Click to Show/Hide

Standard Type	Value	Units	Cell Line	Disease Model
Tumor Growth Inhibition value (TGI)	≈ 11.6	%	Karpas-299 cells	ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 41.5	%	SU-DHL-1 cells	Anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 51.3	%	SU-DHL-1 cells	Anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 68.4	%	Karpas-299 cells	ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 93.2	%	Karpas-299 cells	ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 94.1	%	SU-DHL-1 cells	Anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 97.1	%	Karpas-299 cells	ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 98.4	%	Karpas-299 cells	ALK-positive anaplastic large cell lymphoma
Tumor Growth Inhibition value (TGI)	≈ 98.8	%	SU-DHL-1 cells	Anaplastic large cell lymphoma

Standard Type	Value	Units	Cell Line	Disease Model
Half Maximum Growth Inhibitory Concentration (GI50)	0.26	pM	EoL-1 cells	Chronic eosinophilic leukemia
Half Maximum Growth Inhibitory Concentration (GI50)	4.96	pM	SU-DHL-1 cells	Anaplastic large cell lymphoma
Half Maximum Growth Inhibitory Concentration (GI50)	17.07	pM	Karpas-299 cells	ALK-positive anaplastic large cell lymphoma
Half Maximum Growth Inhibitory Concentration (GI50)	19.6	pM	HDLM-2 cells	Hodgkin lymphoma
Half Maximum Growth Inhibitory Concentration (GI50)	> 6667	pM	KG-1 cells	Adult acute myeloid leukemia
Half Maximum Growth Inhibitory Concentration (GI50)	> 6667	pM	HuT 78 cells	T lymphocytic leukemia
Half Maximum Growth Inhibitory Concentration (GI50)	> 6667	pM	Daudi cells	Burkitt lymphoma
Half Maximum Growth Inhibitory Concentration (GI50)	> 6667	pM	Ramos cells	Burkitt lymphoma
Half Maximum Growth Inhibitory Concentration (GI50)	7.49 1.11	pM ng/mL	L-540 cells	Hodgkin lymphoma

Experiment 1 Reporting the Activity Date of This ADC					[4]
Efficacy Data	Progression Free Survival	9.1 months
Patients Enrolled	Key inclusion criteria: Adults (≥18 years, ≥16 in US) with relapsed/refractory cHL (≥3 prior therapies including BV+CPI, or ≥2 if HSCT-ineligible), measurable disease (Lugano 2014), ECOG 0-2, and adequate organ function. FFPE tumor tissue and negative beta-HCG (WOCBP) required. Contraception mandated for 9.5 months (females) or 6.5 months (males) post-treatment.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT04052997	Clinical Status	PHASE2
Clinical Description	A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Primary Endpoint	The study evaluates efficacy endpoints including ORR (CR+PR per Lugano 2014), DOR (time from first response to progression/death), CR rate, RFS (time from CR to progression/death), PFS (time from first dose to progression/death), and OS (time from first dose to death). Safety assessments cover TEAEs (from first dose to 30 days post-last dose or new therapy start), SAEs (life-threatening events/hospitalization), ECOG status (0-5 scale), and HSCT recipients. PK parameters (Cmax, AUC, CL, T1/2, Vss, AI) are analyzed for total antibody, PBD-conjugated antibody, and SG3199 warhead across Cycles 1-2 (21-day cycles). ADA responses and HRQoL changes (EQ-5D-5L VAS, FACT-Lym) are monitored.    Click to Show/Hide
Experiment 2 Reporting the Activity Date of This ADC					[5]
Efficacy Data	Overall response (OR)	71%
Patients Enrolled	Eligible participants were adults (&ge;18 years) with relapsed/refractory lymphoma (WHO-confirmed), ECOG 0-2, adequate organ function (ANC&ge;1500/uL, platelets&ge;75,000/uL, bilirubin&le;1.5&times;ULN), and measurable disease (Lugano 2014). Exclusions included active GVHD, recent transplant (<60 days), autoimmune diseases, uncontrolled comorbidities (e.g., QTc&ge;450ms), or prior ADCT-301 hypersensitivity. Pregnancy, breastfeeding, or inadequate recovery from prior therapy (non-hematologic toxicity >Grade 1) also excluded participation.    Click to Show/Hide
Administration Dosage	Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 ug/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Related Clinical Trial
NCT Number	NCT02432235	Clinical Status	PHASE1
Clinical Description	A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients With Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Primary Endpoint	The study evaluated dose-limiting toxicities (DLTs) during Cycle 1-2 (21-day cycles), including hematologic (Grade 3-4 febrile neutropenia, Grade 4 thrombocytopenia/anemia) and non-hematologic events (Grade 4 tumor lysis, ≥Grade 3 AEs, ≥Grade 2 neuropathy/skin ulcers). The recommended Phase 2 dose was determined by safety data. Treatment-emergent AEs (TEAEs) and serious AEs (SAEs) were monitored for 84 days post-last dose (median treatment: 43 days).    Click to Show/Hide
Other Endpoint	Efficacy endpoints per Lugano 2014 criteria included ORR (CR: complete metabolic/radiologic response; PR: >50% node reduction), DoR (time from response to progression/death), PFS (time from first dose to progression/death), and OS (time to death). Pharmacokinetics (Cmax, Tmax, AUC, half-life, clearance) were analyzed for HuMax-TAC antibody, PBD-conjugated antibody, and free warhead SG3199 across Cycles 1-2. ADA responses were assessed via ECLIA.    Click to Show/Hide
Experiment 3 Reporting the Activity Date of This ADC					[6]
Efficacy Data	Objective Response Rate (ORR)	28%
Patients Enrolled	Eligible participants were adults with advanced/metastatic solid tumors (specific types varied by study phase) refractory to standard therapy, measurable disease per RECIST, ECOG 0-1, and adequate organ function. Key exclusions included autoimmune diseases, recent infections linked to GBS, active CNS metastases, significant comorbidities, or prior CD25 antibody therapy. Combination therapy cohorts excluded patients with intolerance/history of severe immune-related toxicities from checkpoint inhibitors. Contraception requirements were strictly enforced.    Click to Show/Hide
Administration Dosage	Camidanlumab tesirine is administered as a 30-minute intravenous (IV) infusion on Day 1 of each cycle. Participants treated with camidanlumab tesirine as monotherapy, in the initial dose cohort will receive 20 ug/kg Q3W and the highest dose was 150 ug/kg Q3W.
Related Clinical Trial
NCT Number	NCT03621982	Clinical Status	PHASE1
Clinical Description	A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors
Primary Endpoint	The safety profile was assessed through treatment-emergent adverse events (TEAEs) graded by CTCAE v4.0, including serious adverse events (SAEs), dose interruptions/reductions, and dose-limiting toxicities (DLTs) observed during ADCT-301 monotherapy and combination therapy with pembrolizumab over up to 3 years. Safety monitoring covered clinical lab values, vital signs, ECG, and ECOG performance status.    Click to Show/Hide
Other Endpoint	Efficacy endpoints included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Pharmacokinetic parameters (Tmax, AUC, Cmax, clearance, half-life) and anti-drug antibody (ADA) responses were evaluated for ADCT-301 components in serum during treatment cycles, with discontinuation of PK/ADA sampling if therapy switched to pembrolizumab alone.    Click to Show/Hide
Experiment 4 Reporting the Activity Date of This ADC					[6]
Efficacy Data	Disease control rate (DCR)	44%
Patients Enrolled	Eligible participants were adults with advanced/metastatic solid tumors (specific types varied by study phase) refractory to standard therapy, measurable disease per RECIST, ECOG 0-1, and adequate organ function. Key exclusions included autoimmune diseases, recent infections linked to GBS, active CNS metastases, significant comorbidities, or prior CD25 antibody therapy. Combination therapy cohorts excluded patients with intolerance/history of severe immune-related toxicities from checkpoint inhibitors. Contraception requirements were strictly enforced.    Click to Show/Hide
Administration Dosage	Camidanlumab tesirine is administered as a 30-minute intravenous (IV) infusion on Day 1 of each cycle. Participants treated with camidanlumab tesirine as monotherapy, in the initial dose cohort will receive 20 ug/kg Q3W and the highest dose was 150 ug/kg Q3W.
Related Clinical Trial
NCT Number	NCT03621982	Clinical Status	PHASE1
Clinical Description	A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors
Primary Endpoint	The safety profile was assessed through treatment-emergent adverse events (TEAEs) graded by CTCAE v4.0, including serious adverse events (SAEs), dose interruptions/reductions, and dose-limiting toxicities (DLTs) observed during ADCT-301 monotherapy and combination therapy with pembrolizumab over up to 3 years. Safety monitoring covered clinical lab values, vital signs, ECG, and ECOG performance status.    Click to Show/Hide
Other Endpoint	Efficacy endpoints included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Pharmacokinetic parameters (Tmax, AUC, Cmax, clearance, half-life) and anti-drug antibody (ADA) responses were evaluated for ADCT-301 components in serum during treatment cycles, with discontinuation of PK/ADA sampling if therapy switched to pembrolizumab alone.    Click to Show/Hide
Experiment 5 Reporting the Activity Date of This ADC					[7]
Patients Enrolled	Inclusion: Adults &ge;18 with relapsed/refractory AML, MDS, or MDS/MPN post-allogeneic transplant, stable GVHD (grade 1), creatinine clearance &ge;60ml/min, liver function within limits, no pregnancy, and immune suppression &le;20mg prednisone/day. Exclusion: Active infections, CNS disease, recent cancer therapy (3 years), hypersensitivity to CD25 antibodies, severe autoimmune diseases, or recent infections (HSV, EBV, CMV, SARS-CoV-2, etc.).    Click to Show/Hide
Administration Dosage	Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
Related Clinical Trial
NCT Number	NCT04639024	Clinical Status	PHASE2
Clinical Description	An Open-label Pilot Study to Evaluate the Safety and Efficacy of ADCT-301 in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Myeloproliferative Neoplasms.
Primary Endpoint	The study evaluates ADCT-301's morphologic complete response rate (primary endpoint, up to 3 years) and safety (adverse events within 12 weeks post-last dose).
Experiment 6 Reporting the Activity Date of This ADC					[8]
Patients Enrolled	Eligibility requires relapsed/refractory CD25+ AML/ALL (WHO criteria), ECOG 0-2, adequate organ function (creatinine &le;1.5mg/dL, ALT/AST &le;2&times;ULN, bilirubin &le;1.5&times;ULN), and WBC <15,000/uL. Exclusions include active CNS leukemia, GVHD, recent transplant (&le;60 days), HIV/HBV/HCV, QTc &ge;450ms, prior immunogenicity to CD25 antibodies, or other malignancies (exceptions: non-melanoma skin cancer, in situ cancers). Concurrent experimental therapies or unresolved toxicities (>Grade 1) are prohibited.    Click to Show/Hide
Administration Dosage	Weekly administration - Participants will receive an IV infusion of ADCT-301, on Days 1, 8, and 15 of each 3-week (21-day) cycle.3-week administration - Participants will receive an IV infusion of ADCT-301, on Day 1 of each 3-week (21-day) cycle.The dose escalation will be conducted according to a 3+3 design.
Related Clinical Trial
NCT Number	NCT02588092	Clinical Status	PHASE1
Clinical Description	A Phase 1, Open-label, Dose-escalation, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Activity of ADCT 301 in Patients With Relapsed or Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia
Primary Endpoint	The study evaluates dose-limiting toxicities (DLTs) in Cycle 1 (Days 1-21), defining hematologic DLTs as Grade 3+ neutropenia/thrombocytopenia or Grade 4 anemia with hypocellular marrow (≥6 weeks) and non-hematologic DLTs as Grade 4 tumor lysis, Grade 3+ AEs (excluding alopecia), or Grade 2+ neuropathy. The recommended dose for Part 2 is determined by safety data from Part 1. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) are monitored up to 24 weeks post-treatment, with SAEs including life-threatening events, hospitalization, or death.    Click to Show/Hide
Other Endpoint	Efficacy endpoints include duration of response (DOR) from first response to progression/death, overall response rate (ORR) as CR/CRi/PR rates, and overall survival (OS) from first dose to death. Pharmacokinetics (Cmax, Tmax, AUC, half-life, clearance) are analyzed for PBD-conjugated antibody, total antibody, and free warhead (SG3199) in Q3W and QW dosing schedules. Anti-drug antibodies (ADA) are assessed through Cycle 2.    Click to Show/Hide
Experiment 7 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Complete Remission (CR)	48.60 35.00 6.50 10.00 7.10 0.00 %
Patients Enrolled	Relapsed or refractory classical Hodgkin lymphoma or non-Hodgkin lymphoma, an Eastern Cooperative Oncology Group performance status 0-2, who had no therapies available to them with established clinical benefit for their disease stage were enrolled.
Administration Dosage	Intravenously (3-150 ug/kg) once every 3 weeks.
Related Clinical Trial
NCT Number	NCT02432235	Clinical Status	Phase 1
Clinical Description	A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.
Primary Endpoint	The maximum tolerated dose was not reached. The recommended doses for expansion were 30 ug/kg and 45 ug/kg for patients with classical Hodgkin lymphoma and 80 ug/kg for patients with T-cell non-Hodgkin lymphomas. No recommended doses for expansion were defined for B-cell non-Hodgkin lymphomas.
Other Endpoint	In the cHL cohort,ORR (95% CI) was 86.49% at 45 ug/kg (32/37 patients [71.20-95.50]) and 55.00% at 30 ug/kg (11/20 patients [31.50-76.90]); 48.65% (18/37 patients) and 35.00% (7/20 patients) achieved CR. Median (95% CI) DOR for the cHL population was 6.64 months (5.06-8.11),and was 7.16 months (4.57-8.51) in patients treated at 45 ug/kg.
Experiment 8 Reporting the Activity Date of This ADC					[10]
Patients Enrolled	Antecedent myelodysplastic syndrome who received treatment with hypomethylating agents and subsequently presented with CD25-positive AmL, or patients with R/R CD25-positive acute lymphocytic leukemia (ALL) who had failed or were intolerant to any established therapy, or for whom no other treatment options were available.
Administration Dosage	Intravenously at 3-92 ug/kg once every three weeks (Q3W) or 30 or 37.50 ug/kg every week (QW).
Related Clinical Trial
NCT Number	NCT02588092	Clinical Status	Phase 1
Clinical Description	A phase 1, open-label, dose-escalation, multicenter study to evaluate the tolerability, safety, pharmacokinetics, and activity of ADCT 301 in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) or CD25-positive acute lymphoblastic leukemia.
Primary Endpoint	Two patients achieved complete responses with incomplete hematologic recovery; one each at 30.00 and 37.50 ug/kg QW.
Other Endpoint	Of 16 patients with post-baseline disease assessments, two patients treated on the QW dosing regimen had a complete response (CR).
Experiment 9 Reporting the Activity Date of This ADC					[11]
Patients Enrolled	Relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.
Administration Dosage	45 ug/kg Q3W for 2 cycles and then 30 ug/kg Q3W thereafter; intravenous administration.
Related Clinical Trial
NCT Number	NCT02432235	Clinical Status	Phase 1
Clinical Description	A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma.
Primary Endpoint	The ORR was 40%,representing 51 responders (patients achieved a best overall response of confirmed PR).
Other Endpoint	Of the 130 patients included in the safety analysis, 27 (20.77%) experienced grade2 increased GGT, 17 (13.08%) experienced a grade2 neurologic AE,and 18 (13.85%) experienced a grade2 autoimmune AE at cycle 6.

Experiment 1 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 11.60%	Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.1 mg/kg.    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	ALK-positive anaplastic large cell lymphoma	Karpas-299 cells		CVCL_1324
Experiment 2 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 41.50%	High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.3 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	Anaplastic large cell lymphoma	SU-DHL-1 cells		CVCL_0538
Experiment 3 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 51.30%	High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.3 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	Anaplastic large cell lymphoma	SU-DHL-1 cells		CVCL_0538
Experiment 4 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 68.40%	Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.2 mg/kg.    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	ALK-positive anaplastic large cell lymphoma	Karpas-299 cells		CVCL_1324
Experiment 5 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 93.20%	Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.4 mg/kg.    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	ALK-positive anaplastic large cell lymphoma	Karpas-299 cells		CVCL_1324
Experiment 6 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 94.10%	High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.6 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	Anaplastic large cell lymphoma	SU-DHL-1 cells		CVCL_0538
Experiment 7 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 97.10%	Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000).Vechicle (PBS), ADCT-301 (dar 2.2), nonbinding ADC (DAR 2.1) or Adcetris (DAR~4) were administered intravenously at a mean Karpas 299 tumor volume of 130mm3 as single doses at 0.5 mg/kg.    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	ALK-positive anaplastic large cell lymphoma	Karpas-299 cells		CVCL_1324
Experiment 8 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 98.40%	Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Karpas 299 with moderate CD25 expression (molecules per cell surface=76000). Compared with injection of vehicle (PBS), ADCT-301 administered intravenously (i.v.) at a mean tumor volume of 160 mm3 as a single dose at 0.6mg/kg.    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	ALK-positive anaplastic large cell lymphoma	Karpas-299 cells		CVCL_1324
Experiment 9 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 98.80%	High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description	Camidanlumab tesirine induces efficient tumor cell killing in CDX models of an anaplastic large cell lymphoma (ALCL) cell line Su-DHL-1 with high CD25 expression (molecules per cell surface=310000).ADCT-301 was administered intravenously at mean tumor volume of 155 mm3 at single doses of 0.6 mg/kg and tumor growth compared with that observed after injection of vehicle (PBS).    Click to Show/Hide
In Vivo Model	Anaplastic large cell lymphoma CDX model
In Vitro Model	Anaplastic large cell lymphoma	SU-DHL-1 cells		CVCL_0538

Experiment 1 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	0.26 pM	Moderate CD25 expression (CD25++; 17,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	Chronic eosinophilic leukemia	EoL-1 cells		CVCL_0258
Experiment 2 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	4.96 pM	High CD25 expression (CD25+++; 310,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	Anaplastic large cell lymphoma	SU-DHL-1 cells		CVCL_0538
Experiment 3 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	17.07 pM	Moderate CD25 expression (CD25++; 76,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	ALK-positive anaplastic large cell lymphoma	Karpas-299 cells		CVCL_1324
Experiment 4 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	19.6 pM	High CD25 expression (CD25+++; 167,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	Hodgkin lymphoma	HDLM-2 cells		CVCL_0009
Experiment 5 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	> 6667 pM	Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	Adult acute myeloid leukemia	KG-1 cells		CVCL_0374
Experiment 6 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	> 6667 pM	Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	T lymphocytic leukemia	HuT 78 cells		CVCL_0337
Experiment 7 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	> 6667 pM	Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	Burkitt lymphoma	Daudi cells		CVCL_0008
Experiment 8 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	> 6667 pM	Negative CD25 expression (CD25-; <1,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	Burkitt lymphoma	Ramos cells		CVCL_0597
Experiment 9 Reporting the Activity Date of This ADC					[12]
Efficacy Data	Half Maximum Growth Inhibitory Concentration (GI50)	7.49, 1.11 pM, ng/mL	Moderate CD25 expression (CD25++; 96,000 CD25 molecules/cell)
Method Description	The inhibitory activity of ADCT-301 against cancer cell growth was evaluated in various human cancer cell lines in vitro. CD25-positive and -negative cell lines were incubated with increasing concentrations of ADCT-301 or free warhead (SG3199) for 96 hours before processing by the MTS assay.
In Vitro Model	Hodgkin lymphoma	L-540 cells		CVCL_1362

Ref 1	CD25-targeted antibody-drug conjugate camidanlumab tesirine for relapsed or refractory classical Hodgkin lymphoma
Ref 2	Camidanlumab tesirine in patients with relapsed or refractory lymphoma: a phase 1, open-label, multicentre, dose-escalation, dose-expansion study
Ref 3	Exposure-response analysis of Camidanlumab tesirine in patients with relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma
Ref 4	Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Ref 5	Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma
Ref 6	Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
Ref 7	ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN
Ref 8	Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL)
Ref 9	Camidanlumab tesirine in patients with relapsed or refractory lymphoma: a phase 1, open-label, multicentre, dose-escalation, dose-expansion study. Lancet Haematol. 2021 Jun;8(6):e433-e445.
Ref 10	Camidanlumab tesirine, an antibody-drug conjugate, in relapsed/refractory CD25-positive acute myeloid leukemia or acute lymphoblastic leukemia: A phase I study. Leuk Res. 2020 Aug;95:106385.
Ref 11	Exposure-response analysis of Camidanlumab tesirine in patients with relapsed or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2023 Jan;91(1):1-12.
Ref 12	ADCT-301, a Pyrrolobenzodiazepine (PBD) Dimer-Containing Antibody-Drug Conjugate (ADC) Targeting CD25-Expressing Hematological Malignancies. Mol Cancer Ther. 2016 Nov;15(11):2709-2721.