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Phase I study of [131I] ICF01012, a targeted radionuclide therapy, in metastatic melanoma: MELRIV-1 protocol.

Authors
  • Thivat, Emilie1, 2, 3
  • Rouanet, Jacques4, 5
  • Auzeloux, Philippe4
  • Sas, Nicolas4, 6
  • Jouberton, Elodie4, 7
  • Levesque, Sophie4, 8, 9
  • Billoux, Tommy4, 6
  • Mansard, Sandrine5
  • Molnar, Ioana4, 8, 10
  • Chanchou, Marion4, 7
  • Fois, Giovanna11
  • Maigne, Lydia11
  • Chezal, Jean-Michel4
  • Miot-Noirault, Elisabeth4
  • D'Incan, Michel4, 5
  • Durando, Xavier4, 8, 10, 12
  • Cachin, Florent4, 10, 7
  • 1 INSERM U1240 IMoST, Université Clermont Auvergne, F-63000, Clermont-Ferrand, France. [email protected] , (France)
  • 2 Département de Recherche Clinique, Délégation Recherche Clinique et Innovation, Centre Jean PERRIN, F-63000, Clermont-Ferrand, France. [email protected] , (France)
  • 3 Centre d'Investigation Clinique UMR501, F-63000, Clermont-Ferrand, France. [email protected] , (France)
  • 4 INSERM U1240 IMoST, Université Clermont Auvergne, F-63000, Clermont-Ferrand, France. , (France)
  • 5 Service de Dermatologie et d'Oncologie Cutanée, CHU Clermont-Ferrand, F-63000, Clermont-Ferrand, France. , (France)
  • 6 Service de Physique Médicale, Centre Jean PERRIN, F-63000, Clermont-Ferrand, France. , (France)
  • 7 Service de Médecine Nucléaire, Centre Jean PERRIN, F-63000, Clermont-Ferrand, France. , (France)
  • 8 Département de Recherche Clinique, Délégation Recherche Clinique et Innovation, Centre Jean PERRIN, F-63000, Clermont-Ferrand, France. , (France)
  • 9 Unité de radiopharmacie, Centre Jean PERRIN, F-63000, Clermont-Ferrand, France. , (France)
  • 10 Centre d'Investigation Clinique UMR501, F-63000, Clermont-Ferrand, France. , (France)
  • 11 Laboratoire de Physique de Clermont UMR6533, CNRS/IN2P3, Université Clermont Auvergne, Clermont-Ferrand, France. , (France)
  • 12 Département d'oncologie médicale, Centre Jean PERRIN, F-63000, Clermont-Ferrand, France. , (France)
Type
Published Article
Journal
BMC Cancer
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Apr 15, 2022
Volume
22
Issue
1
Pages
417–417
Identifiers
DOI: 10.1186/s12885-022-09495-3
PMID: 35428211
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Benzamide-based radioligands targeting melanin were first developed for imaging melanoma and then for therapeutic purpose with targeted radionuclide therapy (TRT). [131I]ICF01012 presents a highly favorable pharmacokinetics profile in vivo for therapy. Tumour growth reduction and increase survival have been established in preclinical models of melanoma. According the these preclinical results, we initiate a first-in-human study aimed to determine the recommended dose of [131I]ICF01012 to administer for the treatment of patients with pigmented metastatic melanoma. The MELRIV-1 trial is an open-label, multicentric, dose-escalation phase I trial. The study is divided in 2 steps, a selection part with an IV injection of low activity of [131I]ICF01012 (185 MBq at D0) to select patients who might benefit from [131I]ICF01012 TRT in therapeutic part, i.e. patient presenting at least one tumour lesion with [131I]ICF01012 uptake and an acceptable personalized dosimetry to critical organs (liver, kidney, lung and retina). According to dose escalation scheme driven by a Continual Reassessment Method (CRM) design, a single therapeutic injection of 800 MBq/m2, or 1600 MBq/m2, or 2700 MBq/m2 or 4000 MBq/m2 of [131I]ICF01012 will be administered at D11 (± 4 days). The primary endpoint is the recommended therapeutic dose of [131I]ICF01012, with DLT defined as any grade 3-4 NCI-CT toxicity during the 6 weeks following therapeutic dose. Safety, pharmacokinetic, biodistribution (using planar whole body and SPECT-CT acquisitions), sensitivity / specificity of [131I]ICF01012, and therapeutic efficacy will be assessed as secondary objectives. Patients who received therapeutic injection will be followed until 3 months after TRT. Since 6 to 18 patients are needed for the therapeutic part, up to 36 patients will be enrolled in the selection part. This study is a first-in-human trial evaluating the [131I]ICF01012 TRT in metastatic malignant melanomas with a diagnostic dose of the [131I]ICF01012 to select the patients who may benefit from a therapeutic dose of [131I]ICF01012, with at least one tumor lesion with [131I]ICF01012 uptake and an acceptable AD to healthy organ. Clinicaltrials.gov : NCT03784625 . Registered on December 24, 2018. Identifier in French National Agency for the Safety of Medicines and Health Products (ANSM): N°EudraCT 2016-002444-17. © 2022. The Author(s).

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