Recent Updates
Recently added Catalysts

131I-apamistamab

Phase 3

Acute Leukemia | Small molecule | Oncology |Actinium Pharmaceuticals, Inc. (Delaware)|Last Updated: Sep 9, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment306

FDA Designations

No designations recorded

Clinical trial landscape

131I-apamistamab · 1 trial · 11 indications

Phase 2/3 1
NCT07157514Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AMLAcute Leukemia
NOT YET_RECRUITING306 Analytics
PHASE2/PHASE3NOT YET_RECRUITING
Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML
Acute LeukemiaUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
131I-apamistamabDRUGIodine-131 radiolabeled anti-CD45 monoclonal antibody (apamistamab). Administered IV as a dosimetric dose followed by treatment dose.
FludarabineDRUGFludarabine phosphate, 30 mg/m² IV daily on Days -6 through -2.
CyclophosphamideDRUGCyclophosphamide
Total Body Irradiation (TBI)RADIATIONTBI, 200 cGy on Day -1 prior to HSCT.
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)BIOLOGICALUnmodified, G-CSF-mobilized donor stem cells infused on Day 0.
Unlock Study Design Details

Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT07157514studyFirstPostDate: changed

Frequently asked questions about 131I-apamistamab

What is 131I-apamistamab used for?

131I-apamistamab is an investigational radioimmunotherapy being studied for use in acute leukemia, specifically as conditioning for allogeneic transplant in patients with relapse or refractory acute myeloid leukemia (AML). It is being evaluated in a Phase 2/Phase 3 clinical trial.

How does 131I-apamistamab work?

131I-apamistamab is a radiolabeled antibody that delivers iodine-131 radiation directly to leukemia cells. It is designed to target and irradiate malignant cells as part of a conditioning regimen before allogeneic stem cell transplant, potentially reducing disease burden while preparing the patient for transplantation.

Who is developing 131I-apamistamab?

131I-apamistamab is being developed by Actinium Pharmaceuticals, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol ATNM. The company is conducting clinical research to evaluate the drug's safety and efficacy in acute leukemia.

What phase is 131I-apamistamab in?

131I-apamistamab is currently in Phase 2/Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is designed to assess its use as conditioning therapy for allogeneic transplant in patients with relapse or refractory AML.

What clinical trials is 131I-apamistamab in?

131I-apamistamab is being studied in a single clinical trial registered as NCT07157514, titled 'Radioimmunotherapy Conditioning With 131I-Apamistamab for Allogeneic Transplant in Relapse/Refractory AML.' This Phase 2/Phase 3 trial is not yet recruiting and aims to enroll approximately 306 patients with acute leukemia, including AML.

Is 131I-apamistamab the same as apamistamab?

131I-apamistamab is a radiolabeled form of the antibody apamistamab, where iodine-131 is attached to the antibody. The drug is referred to as 131I-apamistamab in clinical trials, and the name reflects the radioactive isotope component of the investigational therapy.