Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 1 Interventional

Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy

ClinicalTrials.gov ID: NCT01384253

Public ClinicalTrials.gov record NCT01384253. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Trial of Intraperitoneal ²¹²Pb-TCMC-Trastuzumab for HER-2 Expressing Malignancy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for metastatic diseases. This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab, its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive intraperitoneal cancers.

Study identification

NCT ID
NCT01384253
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Orano Med LLC
Industry
Enrollment
18 participants

Conditions and interventions

Eligibility (public fields only)

Age range
19 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2011 (Type not available)
Primary completion
Oct 2015 (Actual)
Completion
Jul 2016 (Actual)
Last update posted
Sep 30, 2016

2011 – 2016

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
University Of Alabama at Birmingham Birmingham Alabama 35233 —
UCSD Moores Cancer Center San Diego California — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01384253, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 30, 2016 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01384253 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →