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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Colorectal Carcinoma
  • Colorectal Neoplasms
  • Stage III Colorectal Cancer AJCC v8
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIB Colorectal Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8

NCT number NCT05204147
Study type Interventional
Source City of Hope Medical Center
Status Not yet recruiting
Phase Phase 1
Start date July 30, 2022
Completion date March 30, 2024

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