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Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer (RITCOLON)

Primary Purpose

Metastatic Colorectal Cancer

Status

Terminated

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Antibody TF2

90-Y-IMP-288

111-In-IMP-288

About this trial

This is an interventional other trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Elevated CEA serum level or proved CEA expression in tumor tissue
≥ 18 years of age,
Given signed, written informed consent
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.
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.
Life expectancy ≥ 3 months, Karnofsky performance status of ≥ 70%
Adequate hematology and renal function and hepatic function
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 :

Known central nervous system metastatic disease
> 25% bone marrow involvement
CEA plasma levels >2,000 ng/mL
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.
HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients
Known autoimmune disease,
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
Infection requiring intravenous antibiotic use within 1 week before inclusion,
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.
Patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.
Known hypersensitivity to murine antibodies or proteins
Immunization against TF2 for patients who has already received injection of TF2
Adult patient unable to give informed consent because of intellectual impairment.
Adult patient protected by the French law
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Sites / Locations

CHU de Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

several cohorts

Arm Description

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

Outcomes

Primary Outcome Measures

To determine the maximum tolerated dose for 90Y-IMP288.

toxicity analysis

Secondary Outcome Measures

Full Information

NCT ID

NCT02300922

First Posted

November 20, 2014

Last Updated

July 29, 2022

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02300922

Brief Title

Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer

Acronym

RITCOLON

Official Title

Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Premature termination of recruitment due to the discontinuation of product supply by the project's industrial partner.

Study Start Date

January 27, 2015 (Actual)

Primary Completion Date

September 20, 2017 (Actual)

Study Completion Date

December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

several cohorts

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Antibody TF2

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

90-Y-IMP-288

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

111-In-IMP-288

Intervention Description

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

Primary Outcome Measure Information:

Title

To determine the maximum tolerated dose for 90Y-IMP288.

Description

toxicity analysis

Time Frame

Week 6 to week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Elevated CEA serum level or proved CEA expression in tumor tissue ≥ 18 years of age, Given signed, written informed consent 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. 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. Life expectancy ≥ 3 months, Karnofsky performance status of ≥ 70% Adequate hematology and renal function and hepatic function 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 : Known central nervous system metastatic disease > 25% bone marrow involvement CEA plasma levels >2,000 ng/mL 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. HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients Known autoimmune disease, 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 Infection requiring intravenous antibiotic use within 1 week before inclusion, 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. Patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment. Known hypersensitivity to murine antibodies or proteins Immunization against TF2 for patients who has already received injection of TF2 Adult patient unable to give informed consent because of intellectual impairment. Adult patient protected by the French law -

Facility Information:

Facility Name

CHU de Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

12. IPD Sharing Statement

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Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer

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