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Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

NCT03784625 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Centre Jean Perrin

    lead OTHER

Principal Investigators

  • Florent CACHIN, Pr · Centre Jean Perrin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2025-01-17
Completion
2025-01-17

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784625 on ClinicalTrials.gov