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Lintuzumab-Ac225

Phase 2

AML | Monoclonal antibody | Oncology |Actinium Pharmaceuticals, Inc. (Delaware)|Last Updated: Jul 19, 2023

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

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Clinical trial landscape

Lintuzumab-Ac225 · 1 trial · 1 indication

Phase 1/2 1
NCT02575963Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) PatientsAML
COMPLETED40 Analytics
PHASE1/PHASE2COMPLETED
Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients
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Study Design & Arms

Interventions

NameTypeDescription
Cytarabine (Phase 1 only)DRUGLow dose cytarabine administered at 20 mg subcutaneously every 12 hours for the first 10 days (Days 1 to 10) of every cycle. Cycle 1 can last up to 52 days (depending on the schedule of study drug dosing) in order to allow for recovery from Lintuzumab-Ac225. Cycles 2-12 will last 28 days each.
Lintuzumab-Ac225BIOLOGICALIn 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 (0.5 μCi/Kg and 7.5 μg /Kg + 0.5 μCi/Kg and 7.5 μg /Kg) with the first fraction administered approximately 4-7 days after 1 cycle of low dose cytarabine and the second fraction administered 4-7 days after the first fraction, followed by up to 11 more cycles. In Phase 2 the dose will be 4.0 μCi/Kg Lintuzumab-Ac225 and 25 μg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given on Day 1 and the second fraction given on Day 5-8.
Furosemide (Phase 1 only)DRUG40 mg by mouth daily one day prior to treatment with Lintuzumab-Ac225 and continuing for 10 days following administration of the 2nd divided dose.
SpironolactoneDRUG25 mg by mouth daily, administered 10 days after second dose of 225Ac-HuM195 and continued for 12 months.
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Frequently asked questions about Lintuzumab-Ac225

What is Lintuzumab-Ac225 used for?

Lintuzumab-Ac225 is an investigational monoclonal antibody being studied for the treatment of acute myeloid leukemia (AML). It is currently in Phase 2 clinical development. The drug is being evaluated in older AML patients, as part of a completed Phase 1/Phase 2 clinical trial.

What does Lintuzumab-Ac225 target?

Lintuzumab-Ac225 is a monoclonal antibody that targets CD33, a protein expressed on the surface of leukemic cells in acute myeloid leukemia (AML). By binding to CD33, the antibody delivers the attached actinium-225 radioisotope to the cancer cells, aiming to destroy them. This mechanism is being studied in clinical trials.

Who makes Lintuzumab-Ac225?

Lintuzumab-Ac225 is being developed by Actinium Pharmaceuticals, Inc., a biopharmaceutical company headquartered in Delaware. The company's stock is traded under the ticker symbol ATNM. Actinium is focused on developing targeted radiotherapies for cancer, including this investigational treatment for acute myeloid leukemia.

What phase is Lintuzumab-Ac225 in?

Lintuzumab-Ac225 is currently in Phase 2 clinical development for the treatment of acute myeloid leukemia (AML). It is an investigational drug and has not been approved by regulatory authorities. The drug has completed a Phase 1/Phase 2 clinical trial, and its development is ongoing.

What clinical trials is Lintuzumab-Ac225 in?

Lintuzumab-Ac225 has been studied in a clinical trial with the identifier NCT02575963, titled 'Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients.' This was a Phase 1/Phase 2 study that has been completed, enrolling 40 participants with AML. The trial was uncontrolled and not randomized or blinded.

Is Lintuzumab-Ac225 the same as lintuzumab?

Lintuzumab-Ac225 is a form of lintuzumab, a monoclonal antibody, that is conjugated to the radioisotope actinium-225. The addition of the radioisotope is what distinguishes Lintuzumab-Ac225 from the unconjugated antibody. This conjugate is being studied for its potential to deliver targeted radiation to AML cells.