COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer (RITCOLON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02300922
Recruitment Status : Unknown
Verified January 2017 by Nantes University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
Phase I/II, Open-labeled, Prospective, Multi-center study of a Pretargeted Radioimmunotherapy in metastatic colorectal cancer with ractionated injections of TF2 plus 90Y-IMP288 (RITCOLON).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Antibody TF2 Drug: 90-Y-IMP-288 Drug: 111-In-IMP-288 Phase 1 Phase 2

Detailed Description:

This study investigates a pretargeted radioimmunotherapy (pRAIT) with the anti-carcinoembryonic antigen (CEA) TF2 bispecific monoclonal antibody (BsMAb) and the 90Y-IMP288 radio-labeled peptide.

TF2 will be given once a week for 3 successive weeks at 75 mg/m2 per dose. IMP288 will be given 3 times, 1 day after each TF2 injection. IMP288 will be radio-labeled with 111In (imaging) for the first injection and then 90Y (therapy) for the 2 subsequent injections.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)
Study Start Date : December 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: several cohorts

All patients will receive 3 injections of TF2 (the first: 14 mg/m², the second and the third:75 mg/m²). One day after each injection of TF2, the patient will receive a radiolabelled peptide (IMP-288) with Yttrium for therapeutic injectionThe First cohort will receive 555 MBq/m2 X 2 of 90-Y-IMP-288.:

All patient will receive 180 MBq of 111-In-IMP-288 for dosimetry analysis

Drug: Antibody TF2
injection of a recombinant antibody CEA specific. Three injections. Each injection are separate by one week

Drug: 90-Y-IMP-288
Injection of the peptide 90-Y-IMP-288, 24 Hours after injection of TF2. 2 injections by patients separated by one week (week 2 and week 3)

Drug: 111-In-IMP-288
Injection of the peptide 111-In-IMP-288, 24 Hours after the first injection of TF2 (week 1)

Primary Outcome Measures :
  1. To determine the maximum tolerated dose for 90Y-IMP288. [ Time Frame: Week 6 to week 12 ]
    toxicity analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Metastatic colorectal cancer and failure to standard therapies (5-fluorouracil, irinotecan, oxaliplatin, anti-vascular endothelium growth factor, anti-epidermal growth factors in patients with RAS wild type tumors). A previous line with regorafenib is not required.
  2. Elevated CEA serum level or proved CEA expression in tumor tissue
  3. ≥ 18 years of age,
  4. Given signed, written informed consent
  5. Existence of at least one measurable tumor lesion by CT or MRI at the time of treatment, but no single lesion ≥ 8 cm in diameter.
  6. At least 4 weeks recovery period after any major surgery, radiation, or chemotherapy, and total recovery from any acute toxicities associated with these prior treatments.
  7. Life expectancy ≥ 3 months, Karnofsky performance status of ≥ 70%
  8. Adequate hematology and renal function and hepatic function
  9. Patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after treatment, and women of childbearing potential must have a negative serum pregnancy test to enter the study

Exclusion Criteria :

  1. Known central nervous system metastatic disease
  2. > 25% bone marrow involvement
  3. CEA plasma levels >2,000 ng/mL
  4. Patients with successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
  5. HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients
  6. Known autoimmune disease,
  7. Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy, no known history of clinical significant, active chronic obstructive pulmonary disease, or other moderate to severe chronic respiratory illness present within 6 months
  8. Infection requiring intravenous antibiotic use within 1 week before inclusion,
  9. Corticosteroids are not allowed within 2 weeks of study entry nor during the study except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis.
  10. Patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.
  11. Known hypersensitivity to murine antibodies or proteins
  12. Immunization against TF2 for patients who has already received injection of TF2
  13. Adult patient unable to give informed consent because of intellectual impairment.
  14. Adult patient protected by the French law


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02300922

Layout table for location information
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital

Layout table for additonal information
Responsible Party: Nantes University Hospital Identifier: NCT02300922    
Other Study ID Numbers: RC14_0003
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Immunologic Factors
Physiological Effects of Drugs