Study of TF2 Carcinoembryonic Antigen (CEA) Antibody in Patients With Metastatic Colorectal Cancer

NCT01273402 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-08-16

No results posted yet for this study

Summary

This study is being done to select an appropriate TF2 bsMAb dose suitable for pretargeting the 111In/90Y-labeled hapten-peptide (IMP-288). Eligible patients will receive a fixed dose of 90Y-IMP-288 4 days after the TF2 antibody injection. Two different dose levels of TF2 will be studied in the first part.

Once an appropriate TF2 dose is selected based on information learned from the first 2 dose levels, patients will be enrolled onto several different increasing dose levels of 90Y-IMP-288.

Conditions

Interventions

DRUG

TF2/IMP288

TF2 is administered 4 days prior to radiolabeled IMP288. Each are given weekly for 2 weeks.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • Robert Sharkey, PhD · Garden State Cancer Center/Center for Molecular Medicine and Immunology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-02-28
Completion
2018-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01273402 on ClinicalTrials.gov