Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient with metastatic melanoma failure to recommended treatments by HAS.

- Initial histological diagnosis of cutaneous melanoma pigmented or unknown status or choroidal melanoma.

- Presence of at least one measurable lesion and / or evaluable in 18FDG-PET as PERCIST criteria.

- Presence of at least one measurable lesion and / or evaluable as CT RECIST 1.1 criteria.

- WHO performance index ≤ 2 .

- Age> 18 years.

- Life expectancy> 3 months.

Exclusion Criteria:

- Brain metastases symptomatic.

- Patient with a VI skin phototype.

- Previous treatment with chemotherapy, radiotherapy, immunotherapy and targeted therapy in the previous 4 weeks, the first injection of [131I] ICF01012.

- Pregnant woman, nursing or woman of childbearing age refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose.

- Men refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose.

- Other evolutionary known cancer in the past five years.

- Earlier irradiation of more than 25% of the bone marrow.

- Suspicion of invasion of more than 25% of the bone marrow on imaging 18F-FDG PET-CT.

- External Radiotherapy on target organs or the maximum dose as recommended in force.

- Uncontrolled diabetes.

- Known history of allergy to the excipients of the solution of [131I]ICF01012.

- Any comorbidity or severe disease at the discretion of the investigator

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03784625
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Jean Perrin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Florent CACHIN, Pr
Principal Investigator Affiliation	Centre Jean Perrin
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Additional Details

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)

Arms & Interventions

Arms

Experimental: therapeutic dose activity (level 1)

[131]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)

Experimental: therapeutic dose activity (level 2)

[131]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)

Experimental: therapeutic dose activity (level 3)

[131]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)

Experimental: therapeutic dose activity (level 4)

[131]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)

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)

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Jean Perrin, Clermont-Ferrand, France

Status

Recruiting

Address

Centre Jean Perrin

Clermont-Ferrand, ,

Site Contact

Florent Cachin, Pr

[email protected]

33473278089

CHU Clermont-Ferrand, Clermont-Ferrand, France