NCT05204147 · City of Hope Medical Center
Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A
Given IV
PROCEDURE
Biospecimen Collection
Correlative studies
Primary outcome measures
Incidence of adverse events
Time frame: Up 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Duarte, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations