Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0NKVYN
ADC Name
RG7882
Synonyms
RG7882; DMUC4064A
   Click to Show/Hide
Organization
Roche (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
2
Structure
Antibody Name
MMUC3333A
  Antibody Info 
Antigen Name
Mucin-16 (MUC16)
  Antigen Info 
Payload Name
MMAE
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Reactive Cysteines
Combination Type
vedotin
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
Pancreatic cancer
1 Trials
Trial ID
NCT02146313
Ovarian cancer
1 Trials
Trial ID
NCT02146313
General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
Click To Hide/Show 48 Absorption Data Related to This Level
Standard Type Value Units Description Reference
Time to Maximum Concentration (Tmax) 0.0838 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.216 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 0.774 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 0.0757 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.397 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.61 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 0.118 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.581 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.27 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 0.1 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.804 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.68 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 0.156 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.823 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.4 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 0.126 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 1.22 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.28 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 0.151 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 1.32 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.55 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 0.166 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 1.76 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.97 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 63.1 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.252 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.03 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 62.7 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.427 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 65.4 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.623 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.56 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 64.3 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.908 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 5.3 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 64.7 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 0.764 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.15 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 70.1 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 1.03 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.32 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 75.8 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 1.3 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Time to Maximum Concentration (Tmax) 77.1 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Maximum Observed Concentration (Cmax) 1.23 ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.9 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Distribution
Click To Hide/Show 32 Distribution Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 0.774 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Volume of Distribution (Vd) 59.1 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.61 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Volume of Distribution (Vd) 62.4 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.27 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Volume of Distribution (Vd) 68.8 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.68 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Volume of Distribution (Vd) 66.3 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.4 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Volume of Distribution (Vd) 73 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.28 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Volume of Distribution (Vd) 59.8 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.55 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Volume of Distribution (Vd) 65.2 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.97 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Volume of Distribution (Vd) 46.4 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.03 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Volume of Distribution (Vd) 12.9 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Volume of Distribution (Vd) 22.5 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.56 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Volume of Distribution (Vd) 34.3 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 5.3 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Volume of Distribution (Vd) 32.4 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.15 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Volume of Distribution (Vd) 38.7 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.32 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Volume of Distribution (Vd) 50.5 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Volume of Distribution (Vd) 48.8 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.9 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Volume of Distribution (Vd) 48.8 mL/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Metabolism
Click To Hide/Show 16 Metabolism Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 0.774 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.61 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.27 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.68 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.4 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.28 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.55 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.97 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.03 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.56 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 5.3 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.15 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.32 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.9 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Excretion
Click To Hide/Show 48 Excretion Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 0.774 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Elimination Half-Life (t1/2) 3.73 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Clearance (CL) 13.7 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.61 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Elimination Half-Life (t1/2) 4.81 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Clearance (CL) 15 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.27 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Elimination Half-Life (t1/2) 5.19 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Clearance (CL) 14.1 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.68 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Elimination Half-Life (t1/2) 6.04 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Clearance (CL) 10.5 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 3.4 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Elimination Half-Life (t1/2) 4.99 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Clearance (CL) 3.6 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.28 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Elimination Half-Life (t1/2) 6.35 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Clearance (CL) 8.64 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.55 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Elimination Half-Life (t1/2) 6.31 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Clearance (CL) 8.87 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.97 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Elimination Half-Life (t1/2) 6.84 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Clearance (CL) 5.96 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 1, 5.6 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 1.03 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Elimination Half-Life (t1/2) 2.93 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Clearance (CL) 10.2 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 2.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Elimination Half-Life (t1/2) 3.55 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Clearance (CL) 9.35 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 1.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.56 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Elimination Half-Life (t1/2) 6.04 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Clearance (CL) 5.83 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 2.4 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 5.3 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Elimination Half-Life (t1/2) 5.07 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Clearance (CL) 6.41 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 3.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.15 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Elimination Half-Life (t1/2) 4.17 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Clearance (CL) 10.6 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.0 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 9.32 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Elimination Half-Life (t1/2) 7.77 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Clearance (CL) 5.25 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 4.8 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.2 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Elimination Half-Life (t1/2) 8.3 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Clearance (CL) 5.55 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.2 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 10.9 day*ug/mL
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Elimination Half-Life (t1/2) 10.3 day
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
Clearance (CL) 4.42 mL/day/kg
The mean (standard deviation) of select pharmacokinetic parameters for ADC, Cycle 1 Day 4, 5.6 mg/kg.
 [1]
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Progression Free Survival  NCT02146313
PHASE1
A Phase I, Open-Label, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of DMUC4064A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer

   Click to Show/Hide
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Efficacy Data Progression Free Survival
5.8 months
Patients Enrolled
Eligible patients include those with MUC16+ ovarian/pancreatic cancers (ECOG 0-1, measurable disease) who progressed after 1-2 prior therapies, excluding those with recent anti-tumor therapy, MUC16/MMAE-targeted treatment, active infections, uncontrolled comorbidities, CNS metastases, or Grade >1 toxicities from prior treatment.
Administration Dosage
DMUC4064A will be administered to participants at a starting dose of 1.0 milligram per kilogram (mg/kg) by IV infusion q3w and would be monitored for DLTs for 21 days after first infusion of Cycle 1 (cycle length=21 days).
Related Clinical Trial
NCT Number NCT02146313  Clinical Status PHASE1
Clinical Description A Phase I, Open-Label, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of DMUC4064A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer
Primary Endpoint
The study evaluates dose-limiting toxicities (DLTs) during Cycle 1 (21 days) to determine maximum tolerated dose (MTD) and recommended Phase II dose of DMUC4064A, while monitoring adverse events (AEs/SAEs) over approximately 3.5 years.
Other Endpoint
Key outcomes include immunogenicity (anti-DMUC4064A antibodies), pharmacokinetic profile, objective response rate (RECIST v1.1), duration of response, and progression-free survival in platinum-resistant ovarian cancer and unresectable pancreatic cancer patients over 3.5 years.
References
Ref 1 An open-label phase I dose-escalation study of the safety and pharmacokinetics of DMUC4064A in patients with platinum-resistant ovarian cancer
Ref 2 A Study Evaluating the Safety and Pharmacokinetics of DMUC4064A in Participants With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer