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Actinium 225 Labeled Anti-CEA Antibody for Advanced Cancers

This study is testing a treatment called Ac225-DOTA-M5A for people with advanced or metastatic cancers that produce CEA (carcinoembryonic antigen). CEA is a protein that can be found in some cancer cells. Ac225-DOTA-M5A is a special antibody linked to a radioactive agent (actinium 225). It's designed to attach to cancer cells that have CEA and deliver the actinium 225 to kill them. The main goals of this study are to find out if Ac225-DOTA-M5A is safe, what side effects it might cause, and what the best dose is. To join, you must have a cancer that expresses CEA, confirmed by a biopsy or elevated blood CEA levels. This study plans to enroll 20 participants.

Study design
This is a dose-escalation study, meaning different doses of the treatment will be tested to find the safest and most effective amount. It plans to include 20 participants.
What's involved
You will receive Ac225-DOTA-M5A through an IV (intravenous, into a vein) over 25 minutes on day 1. Biospecimen (tissue or fluid samples) will also be collected for further study.
Compensation
Not stated in the trial record.
Follow-up
After your treatment, you will be followed weekly for 6-10 weeks, and then your medical records will be reviewed for 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05204147

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~20 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5ABiospecimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 6 months
+1 more outcome measured

Conditions

Advanced Cancer
Metastatic Cancer

Explore related trials

Colorectal CarcinomaSolid NeoplasmCarcinoembryonic Antigen

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jeffrey Y Wong · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Jeffrey Y. Wong
[email protected]
626-359-8111
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must have a histologic diagnosis of a malignancy that expresses CEA. If biopsies were performed at an outside facility, the histology must be reviewed and confirmed by the Department of Pathology at the City of Hope
Patients must have tumors that produce CEA as documented by either an elevated serum CEA above the institutional limit of normal or by immunohistochemical methods. Positive CEA immunohistochemical staining, for the purposes of this protocol, is graded 0-3 and the percentage of tumor cells positive is estimated. A positive CEA stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater
Patients must have an advanced disease for which no standard or effective treatment is available. Patients who refuse a standard but non-curative treatment is available may also be considered
Karnofsky performance status \>= 60% and an estimated survival of at least 3 months
Patients must be \>= 18 years old as phase I data for the antibody is not available for younger patients.
The effects of Ac-225-DOTA-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
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
Presence of measurable disease is required for study entry
All patients must be seen in consultation by City of Hope Radiation Oncology and City of Hope Medical Oncology prior to entry onto this trial
All subjects must have the ability to understand and the willingness to sign a written informed consent
Prior radiotherapy, immunotherapy, or chemotherapy must have been completed at least 4 weeks prior to patient entry on this study (6 weeks if treated with mitomycin-c or nitrosoureas) and patients must have recovered from any expected side effects of prior therapy

Exclusion

Patients should not have any uncontrolled illness including ongoing or uncontrolled active infection
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Pregnant women are excluded from this study because Ac225-DOTA-M5A are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ac225-DOTA-M5A, breastfeeding should be discontinued if the mother is treated with Ac225-DOTA-M5A
Patients with recurrent or progressive brain or leptomeningeal involvement with cancer. Patients that have had previous therapies for brain metastasis or leptomeningeal disease with demonstrated response or stable disease at least four weeks after therapy will be eligible for the trial
Patients who have received previous radiation to \> 50% of their bone marrow
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

What this trial measures

  • Incidence of adverse eventsUp to 6 months

    The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by National Cancer Institute Common Toxicity Criteria and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), and attribution to study drug. Tables will be created to summarize these toxicities and side effects by dose and by course.

  • Maximum tolerated dose (MTD)Up to 36 months

    The MTD is defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicities (DLT) attributable to the study drugs, when at least six patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the DLT-level. At least 6 patients will be treated at the MTD.