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NCT05204147 · ClinicalTrials.gov record · last posted 2026-08-26

Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers

StatusRecruiting
PhasePhase 1
Started2022-06-02
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from the ClinicalTrials.gov record
This phase I study tests the safety, side effects, and best dose of Ac225-DOTA-M5A in treating patients with CEA positive colorectal cancer that has spread to other places in the body (advanced). Ac225-DOTA-M5A is a humanized monoclonal anti-CEA antibody, linked to a radioactive agent called actinium 225. M5A attaches to CEA positive cancer cells in a targeted way and delivers actinium 225 to kill them.

Protocol amendment history 2 changes detected by DataLookout

2026-08-27
critical
Primary completion pushed: 2026-07-21 → 2027-09-10
2026-08-27
minor
Completion pushed: 2026-07-21 → 2027-09-10
Trial Details
NCT Number NCT05204147
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Cancer, Metastatic Cancer
Enrollment 20 participants
Start Date 2022-06-02
Primary Completion 2027-09-10 (estimated)
Study Completion 2027-09-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-26