A Novel CCK2/Gastrin Receptor-Localizing Peptide Probe for Personalized Diagnosis and Therapy of Medullary Thyroid Carcinoma - Gran-T-MTC enrolls patients in a multicentre Phase I Study — ASN Events
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A Novel CCK2/Gastrin Receptor-Localizing Peptide Probe for Personalized Diagnosis and Therapy of Medullary Thyroid Carcinoma - Gran-T-MTC enrolls patients in a multicentre Phase I Study (#116)

Renata Mikolajczak 1 , Paola A. Erba 2 , Clemens Decristoforo 3 , Helmut Maecke 4 , Katja Zaletel 5 , Petra Kolenc-Peitl 5 , Theodosia Maina 6 , Irene Virgolini 3 , Lorenza Scarpa 3 , Marion de Jong 7 , Malgorzata Trofimiuk-Muldner 8 , Agata Jabrocka-Hybel 8 , Alicja Hubalewska-Dydelczyk 8
  1. National Centre for Nuclear Research, Otwock, Poland
  2. Azienda Ospedaliero-Universitaria Pisana, Italy, Pisa, Italy
  3. Innsbruck Medical University, Innsbruck, Austria
  4. University Hospital, Freiburg, Germany
  5. University Medical Centre, Lubljana, Slovenia
  6. INRASTES, NCSR Demokritos,, Athens, Greece
  7. Department of Radiology and Nuclear Medicine, Erasmus MC,, Rotterdam, The Netherlands
  8. Jagiellonian University Medical College, Krakow, Poland

Medullary thyroid cancer (MTC) remains one of the most challenging cancers for both early detection and staging as well as for new therapeutic strategies to control tumor growth. Cholecystokinin 2 receptor (CCK2R) is overexpressed in MTC with high density and >90% incidence. From a variety of peptides with high affinity to CCK2R DOTA-DGlu-DGlu-DGlu-DGlu-DGlu-DGlu-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2 (CP04) has been brought to a phase I clinical trial in the multicentre European project GRAN-T-MTC. The study was designed to establish the safety of 111In-CP04, to assess its biodistribution and dosimetry in MTC and normal tissues, and to determine critical organs. Two dry kit formulations containing 10 ug CP04 for labelling with 200±10% MBq of 111In (low-dose of 111In-CP04) and 50 ug CP04 for labelling with 200±10% MBq of 111In (high-dose of 111In-CP04) have been developed and preclinically characterized allowing its translation to the clinic.  

Inclusion criteria: 25 patients with progressive or metastatic non-operable histologically proven MTC with positive 18F-FDG PET-CT/CT/MRI or elevated serum calcitonin are enrolled in the study. The effect of gelofusine as nephroprotective agent is also evaluated. Study Design: The first 4 patients will receive 2 doses of CP04: first the low-dose of 111In-CP04 then the high-dose. In case of any severe adverse effects (SAE) the other patients will receive the low dose only. If no SAE is encountered, the remaining patients will be randomized for 2 arms: “high-dose” of 111In-CP04 with and without gelofusine infusion. Diagnostic sensitivity/specificity of 111In-CP04 will be assessed.

Conclusions: Running a multicenter clinical trial in Europe is a great challenge from the regulatory point of view. There are good chances that this project will contribute to the development of efficient strategies for the diagnosis, early detection and therapy of recurrent and metastatic MTC patients leading to reduction of mortality as well as improvement of life quality.