What side effects are associated with this type of intervention?

Common treatments similar to Ac225-DOTA-M5A, such as other radiopharmaceutical therapies and targeted monoclonal antibody therapies, often have side effects that include nausea, hematologic toxicities (e.g., thrombocytopenia, lymphopenia, anemia, leukopenia), and potential long-term risks like myelodysplastic syndrome or acute myeloid leukemia. These treatments may also cause localized side effects depending on the targeted area, such as mucositis or dysphagia in head and neck cancer treatments. Overall, while these therapies can be effective, they require careful monitoring for both acute and long-term adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments that involve the targeted delivery of radioactive agents to cancer cells. One notable example is Lutetium Lu 177 vipivotide tetraxetan, which targets PSMA-positive metastatic castration-resistant prostate cancer (CRPC). This treatment uses a radioligand to deliver targeted radiation to cancer cells, similar to the mechanism of Ac225-DOTA-M5A. Another example is Radium-223 dichloride (Ra-223), approved for treating bone metastases in CRPC, which selectively binds to bone metastases and emits alpha particles to kill cancer cells. These approvals highlight the growing use of radiopharmaceuticals in targeted cancer therapy.

What other types of research exist?

Promising alternatives to Ac225-DOTA-M5A for cancer treatment include: <ol> <li>Radium-223 (Ra-223) for symptomatic metastatic castration-resistant prostate cancer (CRPC) with bone metastases, which prolongs overall survival and reduces symptomatic skeletal events.</li> <li></li> </ol> Lutetium-177 (177Lu)-Dotatate for well-differentiated gastrointestinal neuroendocrine tumors, which has shown significant improvement in progression-free survival and quality of life. 3. Terbium-161 (Tb-161) labeled DOTATOC for neuroendocrine neoplasms, which has demonstrated higher efficacy in delaying tumor growth compared to Lutetium-177 counterparts.

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Monoclonal Antibodies

Actinium 225 Anti-CEA Antibody for Colorectal Cancer

Phase 1

Recruiting

Led By Jeffrey Y Wong

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adequate renal function as evidenced by a creatinine =< 1.5 mg/dl and/or a calculated creatinine clearance >= 60 cc/min

Must not have

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 who have received previous radiation to > 50% of their bone marrow

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for advanced colorectal cancer using an antibody linked to a radioactive substance. The treatment targets and kills cancer cells by delivering radiation directly to them. It aims to find the safest dose and understand its effects on patients.

Who is the study for?

Adults with advanced colorectal cancer that produces CEA and has spread, who have no standard treatment options left. They must be in good enough health to participate, not pregnant or breastfeeding, use contraception, and have finished any previous cancer treatments at least 4 weeks ago.

What is being tested?

The trial is testing Ac225-DOTA-M5A, a radioactive drug designed to target and kill CEA positive cancer cells. It's a phase I study which means they're looking for the safest dose with the fewest side effects.

What are the potential side effects?

Potential side effects may include risks associated with radiation such as nausea, fatigue, hair loss near treated areas. There could also be specific reactions where the drug attaches to cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished my last cancer treatment at least 4 weeks ago and have recovered from its side effects.

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My kidney function is good, with creatinine levels at or below 1.5 mg/dl.

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My tumor produces CEA, with more than 30% of cells showing high levels.

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I am 18 years old or older.

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My cancer has been confirmed to express CEA.

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My blood tests show normal white blood cells, neutrophils, and platelets.

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My cancer can be measured by tests or scans.

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My liver functions are within normal limits and less than one-third of my liver is affected by cancer.

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I can care for myself and am expected to live at least 3 more months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have had radiation on more than half of my bone marrow.

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I am not currently on any experimental treatments or other cancer therapies.

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I do not have any uncontrolled illnesses or infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum tolerated dose (MTD)

Secondary study objectives

Best overall response

Overall survival

Progression-free survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Ac225-DOTA-M5A)Experimental Treatment2 Interventions

Patients receive Ac225-DOTA-M5A IV over 25 minutes on day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted therapies, such as Ac225-DOTA-M5A, use monoclonal antibodies to deliver radioactive isotopes directly to cancer cells, minimizing damage to surrounding healthy tissue. This approach is particularly effective for cancers expressing specific markers, like CEA in colorectal cancer. Chemotherapy works by killing rapidly dividing cells but can affect both cancerous and healthy cells, leading to significant side effects. Radiation therapy uses high-energy particles to destroy cancer cells but can also impact nearby healthy tissue. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment, balancing efficacy and side effects.