OncoMatch/Clinical Trials/NCT05204147
Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers
Is NCT05204147 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A for advanced cancer.
Treatment: Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: CEACAM5 overexpression (serum CEA above institutional limit of normal OR >30% tumor cells with IHC intensity 2+ or greater)
malignancy that expresses CEA ... tumors that produce CEA as documented by either an elevated serum CEA above the institutional limit of normal or by immunohistochemical methods ... more than 30% of the tumor cells have an intensity of 2+ or greater
Lab requirements
Blood counts
WBC >= 4000/ul, absolute neutrophil count >= 1500/ul, platelet count >= 125,000/ul
Kidney function
creatinine <= 1.5 mg/dl and/or a calculated creatinine clearance >= 60 cc/min
Liver function
bilirubin <= 1.5 mg/dl and ALT and AST no greater than 2 times the upper limit of normal; less than 1/3 of the liver must be estimated to be involved with tumor
Adequate bone marrow function as evidenced by white blood count (WBC) >= 4000/ul, absolute neutrophil count >= 1500/ul, platelet count >= 125,000/ul are required; Adequate renal function as evidenced by a creatinine <= 1.5 mg/dl and/or a calculated creatinine clearance >= 60 cc/min; Adequate liver function as evidenced by bilirubin <= 1.5 mg/dl and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 2 times the upper limit of normal. Less than 1/3 of the liver must be estimated to be involved with tumor
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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