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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02300922
Other study ID # RC14_0003
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date January 27, 2015
Est. completion date December 20, 2017

Study information

Verified date July 2022
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date December 20, 2017
Est. primary completion date September 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antibody TF2
injection of a recombinant antibody CEA specific. Three injections. Each injection are separate by one week
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)
111-In-IMP-288
Injection of the peptide 111-In-IMP-288, 24 Hours after the first injection of TF2 (week 1)

Locations

Country Name City State
France CHU de Nantes Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the maximum tolerated dose for 90Y-IMP288. toxicity analysis Week 6 to week 12
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