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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial is testing if a humanized monoclonal anti-CEA antibody can effectively and safely kill CEA positive colorectal cancer cells.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Maximum tolerated dose (MTD)

Secondary outcome measures

Best overall response

Overall survival

Progression-free survival

+1 more

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 2

~1730

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,885 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,440 Total Patients Enrolled

Jeffrey Y WongPrincipal InvestigatorCity of Hope Medical Center

8 Previous Clinical Trials

205 Total Patients Enrolled

Media Library

Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05204147 — Phase 1

Cancer Research Study Groups: Treatment (Ac225-DOTA-M5A)

Cancer Clinical Trial 2023: Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A Highlights & Side Effects. Trial Name: NCT05204147 — Phase 1

Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204147 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA greenlit Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A?

"Due to the limited data that exists in regards to efficacy and safety of Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A, it received a score of 1."

Answered by AI

What is the current number of participants in this clinical experiment?

"Affirmative, according to clinicaltrials.gov the trial is actively recruiting participants. Initially posted on June 2nd 2022 and recently modified on August 30th 2022, this study requires 20 individuals from a single medical centre."

Answered by AI

What are the primary goals of this medical research endeavor?

"The principal objective of this 36-month trial is to monitor the frequency of adverse events. Additional goals encompass best overall response, which entails complete or incomplete remission; time to failure from first day of treatment until disease progression/recurrence (utilizing as reference for progressive illness the smallest measurements recorded since initiation); and progression-free survival from initial day of therapy up to the earliest identification of malady advancement or death caused by any cause."

Answered by AI

Are there opportunities for participation in this trial?

"According to information on clinicaltrials.gov, this study is currently in search of participants. The experiment was initially published on June 2nd 2022 and has been updated most recently on August 30th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05204147.