General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0EDBXG
ADC Name
Lintuzumab Ac-225
Synonyms
225Ac-HuM-195; 225Ac-HuM195; 225Ac-lintuzumab; AC225 MOAB M195; AC225-MOAB-M195; Ac-225-Lintuzumab; Ac225 monoclonal antibody M195; Actimab-A; Actimab-M; Actimab-MDS; Actinium (225ac) lintuzumab satetraxetan; Actinium AC 225 lintuzumab; Actinium AC-225 lintuzumab; Actinium-225 (225Ac)-Lintuzumab; Actinium-225-labeled humanized anti-cd33 monoclonal antibody HUM195; Actinium-225-labelled HuM195; HUM-195 AC-225; HuM195-Ac-225; Lintuzumab Ac-225; Lintuzumab actinium Ac-225; Lintuzumab satetraxetan AC-225
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Organization
PDL BioPharma, Inc.; Actinium Pharmaceuticals, Inc.
Drug Status
Phase 1 (Terminated)
Indication
In total 1 Indication(s)
Multiple myeloma
Phase 1
Clinical Trial
Drug-to-Antibody Ratio
Undisclosed
Structure
Antibody Name
Lintuzumab
 Antibody Info 
Antigen Name
Myeloid cell surface antigen CD33 (CD33)
 Antigen Info 
Payload Name
AC225
 Payload Info 
Linker Name
DOTA-P-toluene isothiocyanate
 Linker Info 
Conjugate Type
Undisclosed
Special Approval(s)
Orphan drug(FDA)
Puchem SID
472417814 , 404719693 , 402426007 , 404772496
TTD ID
D0HV7A
ChEBI ID
CHEMBL4297554
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT03441048
Phase 1
A phase 1 study of lintuzumab-Ac225 in combination with CLAG-M chemotherapy in patients with relapsed/refractory acute myeloid leukemia.
Undisclosed  NCT03932318
Phase 1
A phase 1/2 study of venetoclax and azacitidine and lintuzumab-Ac225 in patients with refractory or relapsed AML.
Undisclosed  NCT03867682
Phase 1
A phase 1/2 study of venetoclax and lintuzumab-Ac225 in patients with refractory or relapsed AML.
Undisclosed  NCT02998047
Phase 1
A phase 1 study of lintuzumab-Ac225 in patients with refractory multiple myeloma.
Undisclosed  NCT02575963
Phase 1
A phase 1/2 study of lintuzumab-Ac225 in older patients with untreated acute myeloid leukemia.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
67.00%
Patients Enrolled
Patients with more than 25% of leukemic blasts must have been CD33 positive by flow cytometry.
Administration Dosage
Induction consisted of G-CSF, 300 mg/d, given D1-6, cladribine 5 mg/m2, given D2-6, cytarabine 2 ug/m2, given D2-6, and mitoxantrone 10 mg/m2, given D2-4. Lintuzumab Ac225 was administered as a single dose on either day 7, 8, or 9 with a dose of 0.25 uCi/kg, 0.50 uCi/kg, or 0.75 uCi/kg.
Related Clinical Trial
NCT Number NCT03441048  Clinical Status Phase 1
Clinical Description A phase 1 study of lintuzumab-Ac225 in combination with CLAG-M chemotherapy in patients with relapsed/refractory acute myeloid leukemia.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT03932318  Clinical Status Phase 1
Clinical Description A phase 1/2 study of venetoclax and azacitidine and lintuzumab-Ac225 in patients with refractory or relapsed AML.
Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT03867682  Clinical Status Phase 1
Clinical Description A phase 1/2 study of venetoclax and lintuzumab-Ac225 in patients with refractory or relapsed AML.
Experiment 4 Reporting the Activity Date of This ADC [4]
Related Clinical Trial
NCT Number NCT02998047  Clinical Status Phase 1
Clinical Description A phase 1 study of lintuzumab-Ac225 in patients with refractory multiple myeloma.
Experiment 5 Reporting the Activity Date of This ADC [5]
Related Clinical Trial
NCT Number NCT02575963  Clinical Status Phase 1
Clinical Description A phase 1/2 study of lintuzumab-Ac225 in older patients with untreated acute myeloid leukemia.
References
Ref 1 TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) in advanced non-small cell lung cancer (aNSCLC). J Clin Oncol. 2023 41:16_suppl, 9004-9004.
Ref 2 A Phase I/II Study of Venetoclax and Azacitidine and Lintuzumab-Ac225 in Patients With Refractory or Relapsed AML, NCT03932318
Ref 3 A Phase I/II Study of Venetoclax and Lintuzumab-Ac225 in Patients With Refractory or Relapsed AML, NCT03867682
Ref 4 A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma, NCT02998047
Ref 5 A Phase I/II Study of Lintuzumab-Ac225 in Older Patients With Untreated Acute Myeloid Leukemia, NCT02575963