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

August 12, 2021 updated by: Gilead Sciences

Pretargeted Radioimmunotherapy of Colorectal Cancer: A Phase I Study to Determine Dose-limiting Toxicity and Maximum Tolerated Dose of an Anti-CEACAM5 bsMAb-pretargeted 90Y-hapten-peptide

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients, >18 years of age.
  • documented histologic or cytologic diagnosis of metastatic (Stage IV) colorectal cancer.
  • must have at least one confirmed and measurable tumor lesion (a confirmed tumor site is one in which either biopsy-proven evidence of disease or progressive growth has been radiographically observed).
  • Patients must have failed standard therapy or for whom no standard therapy exists.
  • Patients must have a Karnofsky performance status of ≥ 70% (or equivalent ECOG 0-1) and an expected survival of ≥ 3 months.
  • Patients who previously received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant anti-antibody reactivity with TF2.

  • Hematologic parameters: WBC counts must be ≥ 3000/mm3, granulocytes

    • 1500/mm3, and platelets ≥ 100,000/m3.
  • Non-hematologic parameters: Patients without liver metastases must have bilirubin ≤ 1.5 institutional upper limit of normal (IULN), whereas bilirubin in patients with known liver metastases must be <2.5-times the IULN. AST/ALT must not be >2.5 times IULN.
  • At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis.
  • Patients able to understand and give written informed consent. Informed consent must be obtained prior to baseline studies for enrollment purposes.

Exclusion Criteria:

  • Women who are pregnant or lactating. Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this trial and will be advised that they must use effective contraception during and for a period of 3 months.
  • Patients with plasma CEA >1000 ng/mL or lesions exceeding 10 cm in diameter.
  • Patients with severe anorexia or other gastrointestinal-related symptomatology (e.g., nausea, vomiting).
  • Patients with known HIV or hepatitis B or C.
  • Patients with an active second primary malignancy at the time of study entry, with the exception of carcinoma in situ of the cervix.
  • Patients with known metastatic disease to the central nervous system.
  • Patients with evidence of bone marrow metastases. Screening only required for patients with suspicion of metastases. Patients with ≥ 25% bone marrow involvement are excluded.
  • Patients who are, in the opinion of the investigator, unable to comply with the protocol requirements.
  • Institutionalized subjects (e.g., prisons, psychiatric facilities).
  • Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
  • Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids); or infection requiring intravenous antibiotic use within 1 week.
  • Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
  • Patients who are diabetic and/or have high blood pressure are at a higher risk for developing late-stage renal failure. While these patients will not be specifically excluded, physician-investigators must carefully discuss the associated late risks to these patients.
  • Patients must be at least 4 weeks beyond prior chemotherapy, surgery, radiotherapy to an index lesion, or experimental therapy (i.e., drugs, biologicals, procedures) and meet all eligibility criteria.
  • Patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TF2 and IMP288
TF2 will be administered at least 4 days before the radiolabeled IMP-288.
Drug: TF2/IMP288
TF2 is administered 4 days prior to radiolabeled IMP288. Each are given weekly for 2 weeks.
Other Names:
  • TF2
  • IMP288
  • bi-specific antibodies
  • pre-targeted antibodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the number of adverse events
Time Frame: Safety will be measured routinely during the 3 weeks of administration and afterwards during follow-up for up to 5 years
Safety will be assessed by determing the number of participants with Adverse Events as a Measure of Safety and Tolerability.
Safety will be measured routinely during the 3 weeks of administration and afterwards during follow-up for up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy will be evaluating using CT scans and possibly PET imaging.
Time Frame: Efficacy will be measured at 4 and 8 weeks after treatment and every 3 months for up to 2 years.
CT scans will primarily be used to assess tumor response and to assess the change in tumor size from baseline for up to 2 years.
Efficacy will be measured at 4 and 8 weeks after treatment and every 3 months for up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Robert Sharkey, PhD, Garden State Cancer Center/Center for Molecular Medicine and Immunology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-072-09 (NCI 5R01CA107088-04)
  • 5R01CA107088-04 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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