Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)
Overview
- Phase
- Phase 1
- Intervention
- Antibody TF2
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Nantes University Hospital
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- To determine the maximum tolerated dose for 90Y-IMP288.
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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 :
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Antibody TF2
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
Intervention: 90-Y-IMP-288
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
Intervention: 111-In-IMP-288
Outcomes
Primary Outcomes
To determine the maximum tolerated dose for 90Y-IMP288.
Time Frame: Week 6 to week 12
toxicity analysis