General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0SDZSF
ADC Name
Lorvotuzumab mertansine
Synonyms
lorvotuzumab mertansine; IMGN901; BB-10901; huN901-DM1
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Organization
ImmunoGen (Top20 MNC) (Originator);British Biotech
Drug Status
Phase 2 (discontinued)
Drug-to-Antibody Ratio
3.5
Structure
Antibody Name
Lorvotuzumab
 Antibody Info 
Antigen Name
Neural cell adhesion molecule 1 (NCAM1)
 Antigen Info 
Payload Name
DM1
 Payload Info 
Therapeutic Target
Microtubule (MT)
 Target Info 
Linker Name
N-succinimidyl 4-(2-pyridyldithio) pentanoate (SPP)
 Linker Info 
Conjugate Type
Random Lysines
Combination Type
mertansine
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
Indication Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 New Drug Application Approved
Kidney cancer
1 Trials
Trial ID
NCT02452554
Lung cancer
1 Trials
Trial ID
NCT00625287; NCT00346385
1 Trials
Trial ID
NCT00074256; NCT00065429
1 Trials
Trial ID
NCT02452554
Merkel cell carcinoma
1 Trials
Trial ID
NCT00625287; NCT00346385
Multiple myeloma
1 Trials
Trial ID
NCT00625508; NCT00346255
Ovarian cancer
1 Trials
Trial ID
NCT00625287; NCT00346385
Sarcomas
1 Trials
Trial ID
NCT02452554
Unspecific solid tumor
1 Trials
Trial ID
NCT00074256; NCT00065429
1 Trials
Trial ID
NCT02452554
Unspecified leukaemia
1 Trials
Trial ID
NCT02420873
General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
Click To Hide/Show 31 Absorption Data Related to This Level
Standard Type Value Units Description Reference
Maximum Observed Concentration (Cmax) 32.6 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2.
[1]
Maximum Observed Concentration (Cmax) 39.7 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2.
[1]
Maximum Observed Concentration (Cmax) 50.7 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2.
[1]
Maximum Observed Concentration (Cmax) 54 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2.
[1]
Maximum Observed Concentration (Cmax) 31.9 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2.
[1]
Maximum Observed Concentration (Cmax) 37 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2.
[1]
Maximum Observed Concentration (Cmax) 47.5 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2.
[1]
Maximum Observed Concentration (Cmax) 46.8 ug/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2.
[1]
Area Under the Concentration-Time Curve (AUC) 606 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 752 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 885 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 917 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 444 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 518 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 657 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 627 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 674 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 947 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1090 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 728 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 941 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1022 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUCinf.
[1]
Time to Maximum Concentration (Tmax) 1.67 h
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients.
[2]
Maximum Observed Concentration (Cmax) 125 ug/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients.
[2]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, All.
[2]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, <12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3676 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, >12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3354 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Male.
[2]
Area Under the Concentration-Time Curve (AUC) 6117 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Female.
[2]
Distribution
Click To Hide/Show 21 Distribution Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 606 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 752 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 885 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 917 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 444 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 518 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 657 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 627 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 674 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 947 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1090 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 728 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 941 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1022 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, All.
[2]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, <12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3676 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, >12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3354 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Male.
[2]
Area Under the Concentration-Time Curve (AUC) 6117 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Female.
[2]
Metabolism
Click To Hide/Show 21 Metabolism Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 606 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 752 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 885 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 917 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 444 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 518 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 657 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 627 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 674 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 947 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1090 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 728 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 941 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1022 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, All.
[2]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, <12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3676 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, >12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3354 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Male.
[2]
Area Under the Concentration-Time Curve (AUC) 6117 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Female.
[2]
Excretion
Click To Hide/Show 30 Excretion Data Related to This Level
Standard Type Value Units Description Reference
Elimination Half-Life (t1/2) 16 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2.
[1]
Elimination Half-Life (t1/2) 17.5 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2.
[1]
Elimination Half-Life (t1/2) 15.8 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2.
[1]
Elimination Half-Life (t1/2) 16.3 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2.
[1]
Elimination Half-Life (t1/2) 15.9 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2.
[1]
Elimination Half-Life (t1/2) 17.7 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2.
[1]
Elimination Half-Life (t1/2) 15 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2.
[1]
Elimination Half-Life (t1/2) 15 h
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2.
[1]
Area Under the Concentration-Time Curve (AUC) 606 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 752 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 885 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 917 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 444 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 518 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 657 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 627 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUC0-t.
[1]
Area Under the Concentration-Time Curve (AUC) 674 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 947 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1090 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 1, 112 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 728 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 60 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 941 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8,75 mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1022 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 90mg/m2, AUCinf.
[1]
Area Under the Concentration-Time Curve (AUC) 1033 ug*h/mL
Summary of Plasma Pharmacokinetic Parameters for Lorvotuzumab Mertansine After Infusion in Combination With Carboplatin and Etoposide (Cycle 1), Cycle 1, Day 8, 112 mg/m2, AUCinf.
[1]
Elimination Half-Life (t1/2) 24.6 h
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients.
[2]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, All.
[2]
Area Under the Concentration-Time Curve (AUC) 4184 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, <12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3676 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, >12y.
[2]
Area Under the Concentration-Time Curve (AUC) 3354 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Male.
[2]
Area Under the Concentration-Time Curve (AUC) 6117 ug*h/mL
The PK of lorvotuzumab mertansine was characterized in 15 eligible patients, Female.
[2]
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 7 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT02420873
PHASE2
An Open-label Phase II Study of Lorvotuzumab Mertansine (IMGN901) in CD56 Expressing Hematological Malignancies
Undisclosed  NCT00346255
PHASE1
A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma

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Undisclosed  NCT00991562
PHASE1
An Open-Label Phase I Study of Bb-10901 (IMGN901, huN901-DM10 in Combination With Lenalidomide and Dexamethasone in Patients With CD56-positive Relapsed or Relapsed/Refractory Multiple Myeloma
Undisclosed  NCT02452554
PHASE2
A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; NSC#: 783609) in Children With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma

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Undisclosed  NCT01237678
PHASE1|||PHASE2
A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors Including Extensive Stage Small Cell Lung Cancer

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Undisclosed  NCT00346385
PHASE1
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
Objective Response Rate (ORR)  NCT00346255
Phase 1
BB-10901 in treating patients with relapsed and/or refractory multiple myeloma (IMGN901).
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 7 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [3]
Patients Enrolled
Eligible patients include adults (&ge;18) with CD56+ hematologic malignancies (AML, high-risk MDS, NK leukemia, ALL, CML blast phase, MF, or BPDCN) refractory to prior therapies, ECOG &le;2, adequate organ function, and proper contraception. Exclusions: IMGN901 allergy/hypersensitivity, active CNS disease, grade &ge;3 neuropathy, uncontrolled cardiac/pulmonary/pancreatic conditions, recent major surgery, pregnancy, or protocol non-compliance. Reproductive-age participants must use dual contraception.

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Administration Dosage
100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
Related Clinical Trial
NCT Number NCT02420873  Clinical Status PHASE2
Clinical Description An Open-label Phase II Study of Lorvotuzumab Mertansine (IMGN901) in CD56 Expressing Hematological Malignancies
Primary Endpoint
The primary endpoint is Overall Response Rate (ORR) to IMGN901 in CD56+ hematological malignancies, defined as Complete Remission (CR + CRp + CRi) achieved within three cycles (53-day evaluation).
Other Endpoint
Secondary data collection focuses on safety monitoring but specific endpoints were not predefined in the provided information.
Experiment 2 Reporting the Activity Date of This ADC [4]
Patients Enrolled
Eligible patients must have histologically confirmed, relapsed/refractory CD56+ multiple myeloma (&ge;1 prior therapy, &le;6 regimens at MTD). Key inclusion: ECOG 0-2, adequate organ function, life expectancy &ge;12 weeks, no severe neuropathy, cardiac disease, pancreatitis, or active infections. Exclusion: recent stroke, malignancies (except certain in situ cancers), uncontrolled comorbidities, or prior hypersensitivity to monoclonal antibodies. Prior therapy washout: &ge;4 weeks for chemo/RT/surgery, &ge;2 weeks for biologics. Concurrent bisphosphonates allowed if stable; steroids restricted to specific indications.

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Administration Dosage
dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.
Related Clinical Trial
NCT Number NCT00346255  Clinical Status PHASE1
Clinical Description A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma
Primary Endpoint
This study evaluates dose-limiting toxicity (through cycle 1) and maximum tolerated dose (for the duration of the study).
Other Endpoint
Assessed endpoints include qualitative/quantitative toxicities, pharmacokinetics, and anti-tumor activity (response rate, progression-free survival, overall survival), all measured for the duration of the study.
Experiment 3 Reporting the Activity Date of This ADC [5]
Patients Enrolled
Eligible patients must be &ge;18 years, have ECOG &le;2, meet CD56-positive criteria, and have received 1-3 prior regimens (including lenalidomide/bortezomib if applicable). Exclusions include active infections, significant cardiac disease, recent chemotherapy/radiation, neuropathy &ge;grade 2, or inadequate organ function (ANC &ge;1000, platelets &ge;50K, creatinine &le;1.5x ULN). Strict contraception and compliance with RevAssist&reg; are mandated.

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Administration Dosage
dose escalation study. dosing on days 1, 8 and 15 every 28 days
Related Clinical Trial
NCT Number NCT00991562  Clinical Status PHASE1
Clinical Description An Open-Label Phase I Study of Bb-10901 (IMGN901, huN901-DM10 in Combination With Lenalidomide and Dexamethasone in Patients With CD56-positive Relapsed or Relapsed/Refractory Multiple Myeloma
Primary Endpoint
The study aims to determine the MTD/RPTD and assess the response rate of the combination therapy in patients with CD56-positive relapsed/refractory multiple myeloma, evaluating efficacy through objective response rate, duration of responses, progression-free survival, and overall survival.
Other Endpoint
Key pharmacodynamic outcomes and safety parameters, including ORR, CR rates, time to progression, and survival metrics, will be monitored throughout the study duration.
Experiment 4 Reporting the Activity Date of This ADC [6]
Patients Enrolled
Eligible patients (age &ge;1, Karnofsky/Lansky &ge;50) must have measurable disease (exceptions: MIBG-avid neuroblastoma), prior standard therapy, and adequate organ function (ANC &ge;750-1000/uL, platelets &ge;75K-100K/uL, GFR &ge;70 mL/min). Exclusions include active CNS metastases, neuropathy &ge;grade 2, uncontrolled infections, recent chemotherapy (<3 weeks), pregnancy, or prior IMGN901 exposure. Reproductive-age participants must use contraception.

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Administration Dosage
Patients receive lorvotuzumab mertansine IV over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Related Clinical Trial
NCT Number NCT02452554  Clinical Status PHASE2
Clinical Description A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; NSC#: 783609) in Children With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma
Primary Endpoint
The study evaluates objective response rates (ORR) per RECIST v1.1 in pediatric/adolescent solid tumors (Wilms tumor, rhabdomyosarcoma, neuroblastoma, and other CD56+ malignancies), assessing partial/complete responses over 18 weeks. Toxicity profiles of lorvotuzumab mertansine will be monitored via NCI CTCAE v4.0 for 12 months.
Other Endpoint
Key endpoints focus on response stratification and safety, with Clopper-Pearson confidence intervals for ORR and detailed toxicity summaries by cycle and attribution.
Experiment 5 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients were &ge;18 years with untreated extensive-stage SCLC (ECOG 0-2). Exclusion criteria included pregnancy/lactation and prior SCLC chemotherapy. The control arm served primarily for safety validation rather than powered efficacy comparisons.
Administration Dosage
Phase 2 regimen is IMGN901, Carboplatin, and Etoposide. IMGN901 to be given on days 1 and 8 every 21 days.
Related Clinical Trial
NCT Number NCT01237678  Clinical Status PHASE1|||PHASE2
Clinical Description A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors Including Extensive Stage Small Cell Lung Cancer
Primary Endpoint
The primary Phase I objective was determining the MTD of IMGN901 in combination with carboplatin/etoposide for solid tumors, with DLTs assessed during Cycle 1 (21 days), including febrile neutropenia, grade ≥3 toxicities, and treatment-delaying events. Phase II focused on PFS in extensive-stage SCLC patients comparing the IMGN901 triplet regimen against historical carboplatin/etoposide controls.

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Other Endpoint
Safety profiles were evaluated through TEAEs/SAEs (CTCAE v4.0-graded) until 28 days post-treatment. Secondary efficacy metrics included 6-month PFS rates (experimental arm vs historical 44% benchmark) and median OS, though statistical comparisons were limited by study design.
Experiment 6 Reporting the Activity Date of This ADC [7]
Patients Enrolled
Prior therapy restrictions: &le;3 chemotherapy lines (ovarian patients require platinum exposure), no recent radiotherapy/immunotherapy (4-week washout), and anthracycline doses below cardiotoxicity thresholds. Concurrent antineoplastic treatments are prohibited.
Administration Dosage
dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.
Related Clinical Trial
NCT Number NCT00346385  Clinical Status PHASE1
Clinical Description A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
Primary Endpoint
Safety and pharmacokinetic assessments will evaluate toxicity (via prothrombin time tests) and IMGN901 conjugate/antibody levels during Cycle 1 (21 days), while efficacy focuses on tumor response rates and neuroendocrine biomarkers (neuron-specific enolase/NCAM) measured every 2 cycles.
Other Endpoint
Eligible patients (ECOG 0-2, life expectancy ≥3 months) include relapsed/refractory SCLC (1-3 prior regimens), CD56+ neuroendocrine tumors, and select carcinomas (Merkel cell/ovarian). Key exclusions: uncontrolled metastases, significant cardiorespiratory comorbidities, active infections, or pancreatitis risk factors (elevated LFTs/pancreatic enzymes).

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Experiment 7 Reporting the Activity Date of This ADC [8]
Efficacy Data Objective Response Rate (ORR) 28.30% Positive CD56 expression (CD56+++/++)
Patients Enrolled
Relapsed and/or Refractory CD-56-positive Multiple Myeloma.
Administration Dosage
40 mg/m2 (up to a maximum of 140 mg) intravenously once every 3 weeks.
Related Clinical Trial
NCT Number NCT00346255  Clinical Status Phase 1
Clinical Description BB-10901 in treating patients with relapsed and/or refractory multiple myeloma (IMGN901).
Primary Endpoint
Objective response rate=28.30%.
Other Endpoint
Median progression-free survival=26.10 months (95% CI 1-89 weeks).
References
Ref 1 Phase 1/2 Study of the CD56-Targeting Antibody-Drug Conjugate Lorvotuzumab Mertansine (IMGN901) in Combination With Carboplatin/Etoposide in Small-Cell Lung Cancer Patients With Extensive-Stage Disease
Ref 2 ADVL1522: A phase 2 study of lorvotuzumab mertansine (IMGN901) in children with relapsed or refractory wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, malignant peripheral nerve sheath tumor, or synovial sarcoma-A Children's Oncology Group study
Ref 3 An Open-label Phase II Study of Lorvotuzumab Mertansine
Ref 4 BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma
Ref 5 IMGN901 in Combination With Lenalidomide and Dexamethasone
Ref 6 Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma
Ref 7 BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
Ref 8 A Phase I Study to Assess the Safety and Pharmacokinetics of Single-agent Lorvotuzumab Mertansine (IMGN901) in Patients with Relapsed and/or Refractory CD-56-positive Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):29-34. doi: 10.1016/j.clml.2018.08.018. Epub 2018 Sep 5.