Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0HYRZD
ADC Name
BAY-1862864
Synonyms
BAY 1862864; BAY-1862864; BAY1862864; CD22-Thorium-conjugate; Epratuzumab Th-227 conjugate; epratuzumab-227Th-conjugate; epratuzumab-Th227-conjugate
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Organization
Bayer AG
Drug Status
Phase 1
Antibody Name
Epratuzumab
  Antibody Info 
Antigen Name
B-cell receptor CD22 (CD22)
  Antigen Info 
Payload Name
227Th
  Payload Info 
Linker Name
Undisclosed
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
Lymphoma
1 Trials
Trial ID
NCT02581878
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  NCT02581878
PHASE1
An Open-label Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Biodistribution, Radiation Dosimetry and Pharmacokinetics of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma

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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 [1]
Patients Enrolled
Key inclusion criteria: histologically confirmed relapsed/refractory CD22+ NHL with available tissue for CD22 testing; bone marrow involvement <25%; &ge;1 prior failed chemo/immunotherapy; ineligible for HDT ASCR; ECOG &le;2; life expectancy &ge;12 weeks; adequate organ function; reproductive safety measures; written informed consent
Administration Dosage
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 1.5 MBq (2 mg antibody chelator conjugate [ACC]).
Related Clinical Trial
NCT Number NCT02581878  Clinical Status PHASE1
Clinical Description An Open-label Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Biodistribution, Radiation Dosimetry and Pharmacokinetics of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
Primary Endpoint
Primary endpoint is maximum tolerated dose (MTD) assessment based on dose-limiting toxicities (DLTs) occurrence [Time Frame: Up to 6 weeks].
References
Ref 1 Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma