Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 18, 2019

Primary Completion Date

January 17, 2025

Study Completion Date

January 17, 2025

Conditions
Melanoma
Interventions
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"

Trial Locations (2)

Unknown

Centre Jean Perrin, Clermont-Ferrand

CHU Clermont-Ferrand, Clermont-Ferrand

All Listed Sponsors
lead

Centre Jean Perrin

OTHER

NCT03784625 - Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012 | Biotech Hunter | Biotech Hunter