Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose for 90Y-IMP288.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Antibody TF2 (Drug)
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
干预措施: 90-Y-IMP-288 (Drug)
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
干预措施: 111-In-IMP-288 (Drug)
结局指标
主要结局
To determine the maximum tolerated dose for 90Y-IMP288.
时间窗: Week 6 to week 12
toxicity analysis
次要结局
未报告次要终点