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)
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.
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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288.
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)