TF2- Small Cell Lung Cancer Radio Immunotherapy
|ClinicalTrials.gov Identifier: NCT01221675|
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)||Drug: Antibody TF2 Radiation: IMP-288-Lutetium Radiation: IMP-288-Indium||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||June 2011|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Drug: Antibody TF2
- Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288.
- Primary endpoint of study plan II • the maximum tolerated dose (MTD) for the TF2-pretargeted 177Lu-IMP-288 under optimal pretargeting conditions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221675
|Angers, France, 49100|
|Brest, France, 29000|
|Centre Jean Perrin|
|Clermont Ferrand, France|
|Hôpital La tronche|
|Grenoble, France, 38000|
|Nantes, France, 44093|
|Centre René Gauducheau|
|Saint Herblain, France, 44805|