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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05204147
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Correlative studies

Study Details

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.

Key Dates

Start date
Jun 2, 2022
Status verified
Jul 2026
Primary completion
Jul 21, 2026
Completion
Jul 21, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Ac225-DOTA-M5A)
    Patients receive Ac225-DOTA-M5A IV over 25 minutes on day 1.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Jeffrey Y. Wong
[email protected]
626-359-8111
Jeffrey Y. Wong (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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