Drugs / lintuzumab

Trials 14

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT00502112 Mar 2008 → May 2010 myelodysplastic syndrome Seagen Inc. Completed No outcome recorded
Phase 1 NCT00283114 Nov 2005 → Jan 2010 acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome Seagen Inc. Completed No outcome recorded
Phase 1 NCT00672165 Jul 2005 → Feb 2015 leukemia, myelodysplastic syndrome Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT00038051 May 1999 → Feb 2013 acute myeloid leukemia, chronic myelomonocytic leukemia, refractory anemia with excess blasts in transformation M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT00002890 Oct 1996 → Jan 2001 leukemia, myelodysplastic syndrome Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02575963 Oct 2012 → Nov 2018 acute myeloid leukemia Actinium Pharmaceuticals Completed No outcome recorded
Phase 27 trials · 1 missed
Phase 2 NCT00997243 Nov 2009 → Sep 2010 leukemia, myelodysplastic syndrome Alison Walker Terminated No outcome recorded
Phase 2 NCT00528333 Sep 2007 → Aug 2010 acute myeloid leukemia Seagen Inc. Completed Missed primary
Phase 2 NCT00006084 Feb 2001 → ? leukemia Jonsson Comprehensive Cancer Center Unknown No outcome recorded
Phase 2 NCT00016159 Nov 2000 → Mar 2007 leukemia Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT00003984 Feb 1999 → ? myelodysplastic syndrome European Organisation for Research and Treatment of Cancer - EORTC Withdrawn No outcome recorded
Phase 2 NCT00002800 Jul 1996 → Mar 2003 leukemia, myelodysplastic syndrome, neutropenia Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT00002609 Aug 1994 → Feb 2003 leukemia Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 31 trial
Phase 3 NCT00006045 Mar 2000 → ? leukemia Facet Biotech Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2025-04-28 Actinium Pharmaceuticals Results Actinium Highlights Mutation Agnostic Antileukemic Activity of Actimab-A Against FLT3, NPM1, KMT2A and TP53 Mutations in AML Models Demonstrating Backbone Potential for Acute Myeloid Leukemia Treatment at the American Association for Cancer Research Annual Meeting actiniumpharma.com ↗
Actimab-A significantly potentiated and prolonged efficacy in combination with standard of care targeted therapies including hypomethylating agent azacitidine, FLT3 and menin inhibitors in in-vivo AML models
2023-11-06 Actinium Pharmaceuticals Results Actinium Presents Preclinical Data at SITC Demonstrating Actimab-A's Potential to Restore T Cell Immunity in the Solid Tumor Microenvironment Supporting Immunotherapy Combinations actiniumpharma.com ↗
Actimab-A reduced cancer patient-derived MDSCs in a dose-dependent manner ex vivo and decreased MDSC viability approximately two-fold greater than a non-radiolabeled CD33 antibody
2023-03-16 Actinium Pharmaceuticals Results Actinium to Showcase First-In-Class Targeted Radiotherapies in Two Presentations at the 2023 AACR Annual Meeting actiniumpharma.com ↗
The abstracts highlight the multifaceted anti-cancer activity of CD33-targeted clinical-stage asset Actimab-A and enhanced anti-tumor effect of HER3-targeted, radiotherapy being developed in collaboration with AVEO Oncology, an LG Chem Company.
2020-11-11 Actinium Pharmaceuticals Results Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials actiniumpharma.com ↗
Dr Atallah, as senior investigator, will review the Phase 1 data from the Actimab-A CLAG-M combination trial in relapsed or refractory acute myeloid leukemia (R/R AML) that demonstrated 100% remission in the third and planned final dose cohort.
2020-11-04 Actinium Pharmaceuticals Results 100% Remission Rate Reported in Third Dose Cohort of Actimab-A CLAG-M Phase 1 Combination Trial in Patients with Relapsed or Refractory AML actiniumpharma.com ↗
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") today announced that 100% of evaluable patients in the third and planned final dose cohort of the Actimab-A CLAG-M Phase 1 trial being conducted at the Medical College of Wisconsin (MCW) achieved remission.
2020-11-04 Actinium Pharmaceuticals Results Actinium Announces Actimab-A Venetoclax First-in-Human Data Accepted for Poster Presentation at the 62nd American Society of Hematology Annual Meeting actiniumpharma.com ↗
Combining Actimab-A (225Ac lintuzumab) with venetoclax in patients with R/R AML has an acceptable initial clinical safety profile at the initial subtherapeutic dose level of 0.5 μCi/kg of Actimab-A.
2019-11-06 Actinium Pharmaceuticals Results Actinium Announces Interim Results from Phase 1 Actimab-A CLAG-M Combination Trial in Patients with Relapsed or Refractory AML Accepted for Presentation at ASH 2019 actiniumpharma.com ↗
83% of patients (5/6) receiving 0.50 uCi/kg of Actimab-A and CLAG-M in the second dosing cohort achieved a Complete Remission (CR), Complete Response with incomplete platelet recovery (CRp) or Complete Response with incomplete hematologic recovery (CRi)
2019-04-08 Actinium Pharmaceuticals Results Actinium's Leading Clinical, Preclinical, Production and IP Efforts Related to Actinium-225 Highlighted at Preeminent Targeted Alpha Therapy International Symposium actiniumpharma.com ↗
The results of these studies using pharmacokinetic models determined that accelerator produced Ac-225 labeled to lintuzumab had a negligible impact in the context of therapy compared to generator produced Ac-225.
2019-04-03 Actinium Pharmaceuticals Results Actinium Highlights Actimab-A and Venetoclax Synergies Observed in New Studies Presented at AACR actiniumpharma.com ↗
Actimab-A treatment of venetoclax resistant AML cells led to a decrease in MCL-1 levels.
2018-12-03 Actinium Pharmaceuticals Results Actinium Highlights Actimab-A Phase 2 Trial Results in Older Patients with Unfit AML from ASH Annual Meeting Demonstrating Single Agent Activity of the CD33 Antibody Radiation Conjugate actiniumpharma.com ↗
In this difficult to treat patient population, we are pleased to have observed this level of single-agent activity from Actimab-A with the benefit of minimal extramedullary toxicities.
2013-12-09 Actinium Pharmaceuticals Results Encouraging Clinical Data From Multicenter Phase 1/2 Trial On Actinium's Actimab-A Presented At American Society Of Hematology Annual Meeting actiniumpharma.com ↗
Data demonstrated antileukemic effect in 67% of evaluable patients and 47% of patients treated across all dose levels.
2013-12-02 Actinium Pharmaceuticals Results Actinium Pharmaceuticals Announces Additional Clinical Data From Multicenter Phase 1/2 Trial on Actinium's Actimab-A to Be Presented at American Society of Hematology Annual Meeting actiniumpharma.com ↗
Abstract presented at this year's ASH meeting will report the initial data from the study demonstrating that administration of Actimab-A (monoclonal antibody HuM195 labeled with actinium 225) in fractionated doses is feasible, safe and has antileukemic activity.

All press releases naming this drug 12 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as lintuzumab ClinicalTrials.gov intervention name — accepted as the source's own label NCT00006045 ↗
10

NCT00997243 ↗

NCT00002890 ↗

NCT00502112 ↗

NCT00016159 ↗

NCT00003984 ↗

NCT00528333 ↗

NCT00006084 ↗

NCT00283114 ↗

NCT00002609 ↗

NCT00002800 ↗

Known as 90Y-MOAB HuM195 “yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195)” NCT00002890 ↗
Known as HuM-195/rGel “The goal of this clinical research study is to find the highest safe dose of the anti-CD33 immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies.” NCT00038051 ↗
1

NCT00038051 ↗

Known as HuM195 “A multi-institutional, phase 1 dose-escalation trial of lintuzumab (humanized anti-CD33 antibody; SGN-33, HuM195) was performed in patients with CD33-positive myeloid malignancies.” PMID 19557623 ↗ Aug 2009
4

“Lintuzumab (SGN-33; HuM195) is a humanized monoclonal antibody directed against CD33, which is expressed on the majority of myeloblasts in acute myeloid leukemia.” PMID 22801961 ↗ Jul 2012

“In Phase 1 the starting dose level was 1.0 μCi/Kg of Lintuzumab-Ac225 and 15 μg/Kg unlabeled HuM195 divided into 2 equal fractionated doses” NCT02575963 ↗

“yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195)” NCT00002890 ↗

NCT00672165 ↗

Known as M195 “yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195)” NCT00002890 ↗
Action Deplete “The immunotoxin is designed to selectively destroy myeloid leukemia cells.” NCT00038051 ↗
Modality Monoclonal antibody “humanized anti-CD33 monoclonal antibody” NCT00002609 ↗
Route Intravenous “All patients receive a single intravenous dose of 90Y-MOAB HuM195.” NCT00002890 ↗
Target CD33 “anti-CD33 monoclonal antibody” NCT00002609 ↗