Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0IYBRT
ADC Name
ADCT-602
Synonyms
Epratuzumab-cys-tesirine; hLL2-cys-PBD; hLL2-cys-SG3249; Epratuzumab-cys-SG3249
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Organization
ADC Therapeutics SA
Drug Status
Phase 1/2
Indication
In total 1 Indication(s)
B Lymphoblastic leukaemia [ICD11:2A70]
Phase 2
Drug-to-Antibody Ratio
1.7
Structure
Antibody Name
Epratuzumab
  Antibody Info 
Antigen Name
B-cell receptor CD22 (CD22)
  Antigen Info 
Payload Name
SG3199
  Payload Info 
Therapeutic Target
Human Deoxyribonucleic acid (hDNA)
  Target Info 
Linker Name
Mal-PEG8-Val-Ala-PABC
  Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Combination Type
Tesirine
Puchem SID
472419739 , 404719478
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT03698552
Phase 1
A phase 1/2 study to evaluate the safety and anti-tumor activity of ADCT-602 targeting CD22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Undisclosed  NCT03698552
Phase 1
A phase 1/2 study to evaluate the safety and anti-tumor activity of ADCT-602 targeting CD22 in patients with relapsed or refractory b-cell acute lymphoblastic leukemia.
Undisclosed  NCT03698552
Phase 1
A phase 1/2 study to evaluate the safety and anti-tumor activity of ADCT-602 targeting CD22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
R/R B-acute lymphocytic leukemia (ALL).
Administration Dosage
A 3+3 dose-escalation design was used for phase 1. ADCT-602 was initially given IV once every 3 weeks (30 ug/kg, n=3; 60 ug/kg, n=4; 90 ug/kg, n=4); based on the PK data, the administration schedule was later amended to weekly infusions (30 ug/kg, n=3; 40 ug/kg, n=4; 50 ug/kg, n=3).
Related Clinical Trial
NCT Number NCT03698552  Clinical Status Phase 1
Clinical Description A phase 1/2 study to evaluate the safety and anti-tumor activity of ADCT-602 targeting CD22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Primary Endpoint
In this phase 1 study in pts with very heavily pretreated R/R B-ALL with a median of 5 prior lines of therapy and high baseline bone marrow tumor burden, single-agent ADCT-602 was well tolerated with one pt with DLT noted at the 50 mg/kg weekly dose level. Notably, all 3 pts treated at this dose level had evidence of clinical activity with 2/3 pts achieving MRD negative CR.

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Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
R/R B-acute lymphocytic leukemia (ALL).
Administration Dosage
A 3+3 dose-escalation design was used for phase 1. ADCT-602 was initially given IV once every 3 weeks (30 ug/kg, n=3; 60 ug/kg, n=4; 90 ug/kg, n=4); based on the PK data, the administration schedule was later amended to weekly infusions (30 ug/kg, n=3; 40 ug/kg, n=4; 50 ug/kg, n=3).
Related Clinical Trial
NCT Number NCT03698552  Clinical Status Phase 1
Clinical Description A phase 1/2 study to evaluate the safety and anti-tumor activity of ADCT-602 targeting CD22 in patients with relapsed or refractory b-cell acute lymphoblastic leukemia.
Primary Endpoint
In this phase 1 study in pts with very heavily pretreated R/R B-ALL with a median of 5 prior lines of therapy and high baseline bone marrow tumor burden, single-agent ADCT-602 was well tolerated with no DLTs noted. Two pts achieved MRD-negative remission. Dose escalation in the weekly schedule continues and 2 additional dose levels (40 ug/kg weekly and 50 ug/kg weekly) are planned. PK data, available for 9 pts treated at every 3-week schedule [30 ug/kg, n=3; 60 ug/kg, n=4; 90 ug/kg, n=2] showed rapid clearance of antibody with mean apparent half-life of <1 day during Cycle 1. This supported transitioning ADCT-602 administration to the weekly dosing.

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Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT03698552  Clinical Status Phase 1
Clinical Description A phase 1/2 study to evaluate the safety and anti-tumor activity of ADCT-602 targeting CD22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
References
Ref 1 Adct-602, a CD22 Targeting Antibody Drug Conjugate Bound to PBD Toxin in Adult Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase 1 Trial. Blood (2022) 140 (Supplement 1): 521522.
Ref 2 A Phase 1 Trial of Adct-602, a CD22 Targeting Antibody Drug Conjugate Bound to PBD Toxin in Adult Patients with Relapsed or Refractory CD22+ B-Cell Acute Lymphoblastic Leukemia. Blood (2021) 138 (Supplement 1): 1237.
Ref 3 A Phase I/II Study to Evaluate the Safety and Anti-Tumor Activity of ADCT-602 Targeting CD22 in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, NCT03698552

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