Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (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
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Lymphoma
1 Trials
Clinical trial identifier
NCT02581878
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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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