Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0XYXAL
ADC Name
RG6109
Synonyms
RG6109; DCLL9718S; DCLL9718A
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Organization
Genentech (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
2
Antibody Name
MCLL0517A
  Antibody Info 
Antigen Name
CLL-1
  Antigen Info 
Payload Name
PBD dimer
  Payload Info 
Therapeutic Target
Human deoxyribonucleic acid (hDNA)
  Target Info 
Linker Name
Cleavable disulfide linker
  Linker Info 
Conjugate Type
Reactive Cysteines
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
Acute myeloid leukaemia
1 Trials
Trial ID
NCT03298516
General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
Click To Hide/Show 10 Absorption Data Related to This Level
Standard Type Value Units Description Reference
Maximum Observed Concentration (Cmax) 1.13 ng/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 10 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 0.16 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 10 ug/kg, AUCinf.
 [1]
Maximum Observed Concentration (Cmax) 0.86 ng/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 20 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 0.65 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 20 ug/kg, AUCinf.
 [1]
Maximum Observed Concentration (Cmax) 3 ng/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 40 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.9 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 40 ug/kg, AUCinf.
 [1]
Maximum Observed Concentration (Cmax) 6.94 ng/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 80 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 13 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 80 ug/kg, AUCinf.
 [1]
Maximum Observed Concentration (Cmax) 14 ng/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 160 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.77 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 160 ug/kg, AUCinf.
 [1]
Distribution
Click To Hide/Show 5 Distribution Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 0.16 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 10 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 0.65 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 20 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.9 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 40 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 13 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 80 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.77 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 160 ug/kg, AUCinf.
 [1]
Metabolism
Click To Hide/Show 5 Metabolism Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 0.16 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 10 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 0.65 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 20 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.9 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 40 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 13 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 80 ug/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.77 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 160 ug/kg, AUCinf.
 [1]
Excretion
Click To Hide/Show 15 Excretion Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 0.16 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 10 ug/kg, AUCinf.
 [1]
Clearance (CL) 641 mL/day/kg
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 10 ug/kg.
 [1]
Elimination Half-Life (t1/2) 0.27 day
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 10 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 0.65 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 20 ug/kg, AUCinf.
 [1]
Clearance (CL) 224 mL/day/kg
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 20 ug/kg.
 [1]
Elimination Half-Life (t1/2) 0.48 day
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 20 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 4.9 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 40 ug/kg, AUCinf.
 [1]
Clearance (CL) 1610 mL/day/kg
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 40 ug/kg.
 [1]
Elimination Half-Life (t1/2) 1.11 day
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 40 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 13 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 80 ug/kg, AUCinf.
 [1]
Clearance (CL) 64 mL/day/kg
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 80 ug/kg.
 [1]
Elimination Half-Life (t1/2) 1.2 day
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 80 ug/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 6.77 ng*day/mL
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 160 ug/kg, AUCinf.
 [1]
Clearance (CL) 243 mL/day/kg
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 160 ug/kg.
 [1]
Elimination Half-Life (t1/2) 0.92 day
Pharmacokinetic parameters for DCLL9718S analytes in Cycle 1, 160 ug/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
Undisclosed  NCT03298516
PHASE1
An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of DCLL9718S in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Patients With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy

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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]
Patients Enrolled
Eligible AML patients (excluding APL) must have ECOG 0-2 and adequate organ function. Arm A includes relapsed/refractory AML patients (≥18 years, ≤2 prior regimens), while Arm B enrolls treatment-naive patients (≥75 years or ≥65 years unfit for chemotherapy). Key exclusions include prior transplants, CNS leukemia, pulmonary diseases, recent investigational therapies, active infections (HCV/HBV/HIV), other recent malignancies, or QT prolongation risks.

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Administration Dosage
DCLL9718S will be administered as per the schedule specified in the respective arm.
Related Clinical Trial
NCT Number NCT03298516  Clinical Status PHASE1
Clinical Description An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of DCLL9718S in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Patients With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy
Primary Endpoint
The study evaluates safety outcomes including adverse event rates over 3 years and dose-limiting toxicities during the first treatment cycle (21-28 days depending on arm) to determine maximum tolerated dose and recommended phase 2 dose for DCLL9718S.
Other Endpoint
Pharmacokinetic parameters of DCLL9718S and azacitidine are analyzed over 3 years, including serum/plasma concentrations, AUC, Cmax, clearance, half-life, and volume of distribution. Efficacy assessments per IWG criteria measure complete remission rates (CR/CRi/CRp), overall response, duration of response, overall survival, event-free survival, progression-free survival, and anti-drug antibody development.

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References
Ref 1 A Phase I dose-escalation study of DCLL9718S, an antibody-drug conjugate targeting C-type lectin-like molecule-1 (CLL-1) in patients with acute myeloid leukemia
Ref 2 A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy