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131I-apamistamab

Phase 3

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

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2001

Success Probability

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Market & Valuation

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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.
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Frequently asked questions about 131I-apamistamab

What is 131I-apamistamab?

131I-apamistamab is an investigational monoclonal antibody-based radioimmunotherapy developed by Actinium Pharmaceuticals, Inc. (ATNM). It is being studied as a conditioning regimen before allogeneic transplant in patients with acute leukemia, including relapsed or refractory acute myeloid leukemia. It combines a monoclonal antibody with the radioisotope iodine-131.

What is 131I-apamistamab used for in acute leukemia?

131I-apamistamab is being developed for use in acute leukemia, specifically as radioimmunotherapy conditioning before allogeneic transplant in patients with relapsed or refractory acute myeloid leukemia. The Phase 2/Phase 3 study enrolls patients with AML in relapse or refractory AML, along with related myeloid leukemia conditions.

Who makes 131I-apamistamab?

131I-apamistamab is developed by Actinium Pharmaceuticals, Inc., which trades under the ticker ATNM. The company is sponsoring the clinical program evaluating the agent as a conditioning approach for allogeneic transplant in acute leukemia.

What phase is 131I-apamistamab in?

131I-apamistamab is in Phase 3 development. Its single registered trial, NCT07157514, is listed as Phase 2/Phase 3 and is not yet recruiting. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is 131I-apamistamab in?

131I-apamistamab is being studied in one registered clinical trial, NCT07157514, titled Radioimmunotherapy Conditioning With 131I-Apamistamab for Allogeneic Transplant in Relapse/Refractory AML. The trial is Phase 2/Phase 3, has a planned enrollment of 306 participants, and is currently not yet recruiting.

How does 131I-apamistamab work?

131I-apamistamab is a monoclonal antibody-based radioimmunotherapy, meaning it pairs an antibody with the radioisotope iodine-131. It is designed to deliver targeted radiation as a conditioning regimen before allogeneic transplant in patients with relapsed or refractory acute myeloid leukemia.