Trials / Recruiting
RecruitingNCT05204147
Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers
A Phase I Study of Actinium-225 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced or Metastatic Cancers
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVE: I. To establish the maximum tolerated dose (MTD) of actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A (225Ac-DOTA-M5A) humanized anti-carcinoembryonic antigen (CEA) antibody when given intravenously and to describe the toxicities at each dose studied. SECONDARY OBJECTIVES: I. To begin to evaluate the clinical activity of the agent in metastatic colorectal cancer. II. To evaluate the organ biodistribution, pharmacokinetics and organ dose estimates of 225Ac-DOTA-M5A. OUTLINE: This is a dose-escalation study. Patients receive Ac225-DOTA-M5A intravenously (IV) over 25 minutes on day 1. After completion of study treatment, patients are followed weekly for 6-10 weeks, and then medical records are reviewed for 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A | Given IV |
| PROCEDURE | Biospecimen Collection | Correlative studies |
Timeline
- Start date
- 2022-06-02
- Primary completion
- 2026-07-21
- Completion
- 2026-07-21
- First posted
- 2022-01-24
- Last updated
- 2025-09-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05204147. Inclusion in this directory is not an endorsement.