NCT03784625

Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012: Phase I Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Centre Jean Perrin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase I clinical trial aimed to determine the recommended dose of \[131I\]ICF01012 to administer for the treatment of patients with pigmented metastatic melanoma (binding \[131I\]ICF01012 ). The \[131I\]ICF01012 is a targeted radionuclide therapy with a high affinity for melanin.

Detailed description

This study will include a maximum of 36 patients. This study will begin with a preselection part that consists of an injection of \[131I\]ICF01012 at a diagnostic dose (185 MBq) in order to preselect patients who will receive the therapeutic dose according to the dosimetry results : binding of \[131I\]ICF01012 on at least a tumoral lesion and an acceptable radiation absorbed dose to major organs. The second phase will consist of a therapeutic part with a single administration of \[131I\]ICF01012 at a therapeutic dose. This part is a dose escalation model (4 levels of therapeutic dose were tested)

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	[131I]ICF01012 (therapeutic dose level 1)	* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs) * 1 therapeutic injection (D11) at a dose of 800 MBq/m²
DRUG	[131I]ICF01012 (therapeutic dose level 2)	* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs) * 1 therapeutic injection (D11) at a dose of 1600 MBq/m²
DRUG	[131I]ICF01012 (therapeutic dose level 3)	* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs) * 1 therapeutic injection (D11) at a dose of 2700 MBq/m²
DRUG	[131I]ICF01012 (therapeutic dose level 4)	* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs) * 1 therapeutic injection (D11) at a dose of 4000 MBq/m²

Timeline

• Start date: 2019-10-18
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2018-12-24
• Last updated: 2025-02-13

Locations

2 sites across 1 country: France