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NCT05204147 · ClinicalTrials.gov registry record · Phase 1
Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers
A Phase 1 study of Advanced Cancer and Metastatic Cancer, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05204147: Recruiting Phase 1 study of Advanced Cancer and Metastatic Cancer, sponsored by City of Hope Medical Center.
NCT05204147 is a Phase 1 study of Advanced Cancer and Metastatic Cancer that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 20 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05204147, a Phase 1 study of Advanced Cancer and Metastatic Cancer, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by National Cancer Institute Common Toxicity Criteria and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), and attribution to study drug. Tables will be created to summarize these toxicities and side effects by dose and by course.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-06-02 |
| Est. Completion | 2026-07-21 |
| Phase | Phase 1 |
What NCT05204147 shows while recruiting
NCT05204147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Advanced Cancer appearing as the primary indexed condition, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT05204147 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05204147 about?
NCT05204147 is a clinical study titled "Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers". 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 actiniu...
What is the current status of trial NCT05204147?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-06-02. Estimated completion is 2026-07-21.
What conditions does trial NCT05204147 study?
This clinical trial studies the following conditions: Advanced Cancer, Metastatic Cancer.
What interventions are being tested in trial NCT05204147?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A (DRUG).
Who is sponsoring clinical trial NCT05204147?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05204147 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05204147's enrollment target sits among peer trials
20 112th of 122 higher than 10 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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