- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221675
TF2- Small Cell Lung Cancer Radio Immunotherapy
Prospective Multicentric Optimization and Phase I/II Study of Pretargeted Radioimmunotherapy (PRAIT) Using Anti-CEA x Anti-HSG TF2 Bispecific Antibody (bsMAb) and 177Lu-IMP-288 Peptide in Patients With CEA-expressing Small Cell Lung Carcinoma (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this open-label prospective optimization and phase I/II clinical trial is to examine the safety, optimal dose, targeting, dosimetry and efficacy of PRAIT using the humanized anti-CEA x anti-HSG bsMAb TF2 and the 177Lu-IMP-288 peptide pretargeted in patients with CEA-positive SCLC or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)
This study has 2 parts: Study plan I (Optimization study) and Study plan II (Escalating activity phase I/II study).
The Study plan I is designed to optimize the pretargeting procedure using blood pharmacokinetics (Pk) and dosimetry in 9 patients receiving escalating doses of TF2 followed 2 to 4 days later by 1.1 GBq/m2 of 177Lu-IMP-288.
The study plan II is designed to determined MTD of 177Lu-IMP-288 using dosimetry and toxicity data in a phase I/II study performed in patients receiving optimal dose of TF2 bsMAb (determined in study plan I) followed 2 to 4 days by escalating activity of 177Lu-IMP-288.
A pre-therapy imaging study (using TF2 followed 2 to 4 days later by 185 MBq of 111In-IMP-288) is performed in the two study plans to qualify a patient for treatment with the subsequent therapy dose.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Angers, France, 49100
- CHU d'Angers
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Brest, France, 29000
- CHU
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Clermont Ferrand, France
- Centre Jean Perrin
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Grenoble, France, 38000
- Hôpital La Tronche
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Nantes, France, 44093
- Hotel Dieu
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Saint Herblain, France, 44805
- Centre Rene Gauducheau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Patients with histologic diagnosis of SCLC who are in partial response or who have failed at least two lines of standard radiation and/or chemotherapy. Outside formal contra-indication, patients must have received at least one prior platinum-based chemotherapy.
or
- Patients with histologic diagnosis of NSCLC (without activating mutation of EGFR gene) who have failed at least one line of chemotherapy (platinum in combination with a third generation drug or combination of 2 third generation drug +/-bevacizumab in case of predominance of non-squamous tumor)
- Age ≥ 18 years
- At least 4-weeks after the previous treatment and have recovered from previous radio- or chemotherapy
- Women of child-bearing potential must have a negative pregnancy test.
- Karnofsky performance status ≥ 60 or ECOG performance status 0-2Karnofsky
- Minimum life expectancy of 3 months
- Positive CEA on immunohistology or plasma CEA ≥ 10 ng/mL
- At least one measurable lesion by CT
- At least one abnormal focus by FDG-PET
- Imaging studies must be performed within 1-4 weeks before PRAIT study to document extent of disease
- Signed informed consent form.
Exclusion Criteria:
- Pregnant or lactating woman. Women of child-bearing potential will be asked to practice adequate means of birth control for a minimum of 12 months after treatment.
- Male patient refusing effective contraception for a minimum of 12 months after treatment.
- Brain metastases but patients with brain metastases controlled after treatment by Surgery or radiotherapy since more than 4 weeks are eligibles for the study. An treatment by associated corticotherapy is authorized for these patients.
- Known HIV or hepatitis
- Any serious active disease or comorbid medical condition (according to the investigator's decision and information provided in the IDB)
- Severe disorders of hemostasis or anticoagulant treatment cure
- Extensive irradiation to more than 25% of their red marrow
- Bone marrow involvement to more than 25%
- External radiation to specific organs or areas at the maximum tolerated level
- EGFR gene mutation in tumor (only for NSCLC)
- Febrile aplasia during a previous chemotherapy
- Neutrophils < 1.5 G/l
- Platelets < 100 G/l
- Uncontrolled diabetes
- Poor renal function (creatinine level > 2.5 maximum normal level)
- Poor hepatic function (total bilirubin level > 30 mmol/l, transaminases > 2.5 maximum normal level)
- Treatment with any investigational drug within 30 days before planned PRAIT and during the study
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma,
- Presence of anti-antibody reactivity
- Known hypersensitivity to murine antibodies or proteins
- Adult patient unable to give informed consent because of intellectual impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288.
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Primary endpoint of study plan II • the maximum tolerated dose (MTD) for the TF2-pretargeted 177Lu-IMP-288 under optimal pretargeting conditions.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Small Cell Lung Carcinoma
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
Other Study ID Numbers
- BRD 08/9-O
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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