Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer

NCT02300922 | Terminated Phase 1

• 1 other identifier: RC14_0003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

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

  toxicity analysis

  Week 6 to week 12

Study Arms (1)

several cohorts

EXPERIMENTAL

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; Drug: 90-Y-IMP-288; Drug: 111-In-IMP-288

Interventions

Antibody TF2 DRUG

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

several cohorts

90-Y-IMP-288 DRUG

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)

several cohorts

111-In-IMP-288 DRUG

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

several cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 25, 2014
• Study Start: January 27, 2015
• Primary Completion: September 20, 2017
• Study Completion: December 20, 2017
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

FR (1)