Clinical trial · Interventional
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012: Phase I Study
NCT03784625CI-TRIAL-00085929MELRIV-1completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [131I]ICF01012 (therapeutic dose level 1) | Drug | — | UNRESOLVED |
| [131I]ICF01012 (therapeutic dose level 2) | Drug | — | UNRESOLVED |
| [131I]ICF01012 (therapeutic dose level 3) | Drug | — | UNRESOLVED |
| [131I]ICF01012 (therapeutic dose level 4) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- therapeutic dose activity (level 1)
- description
- \[131\]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)
- interventionNames
- Drug: [131I]ICF01012 (therapeutic dose level 1)
- type
- EXPERIMENTAL
- label
- therapeutic dose activity (level 2)
- description
- \[131\]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)
- interventionNames
- Drug: [131I]ICF01012 (therapeutic dose level 2)
- type
- EXPERIMENTAL
- label
- therapeutic dose activity (level 3)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * Creatinine ≤ 1,5 x ULN or creatinine clearance ≥ 60ml/min if creatinine \> 1,5 x ULN , Neutrophil \> 1,5.109L-1, Platellets \> 100 x 109L-1, prothrombine time \< 1,3 x control, Hemoglobin \> 9 g/dL, facteur V \> 80% (or AST, ALT ≤ 3 x LNS (≤ 5 x ULN if liver metastasis)). * Normal cardiac fonction (LVEF\> 40%). 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
References
Publications (1)
- DERIVEDThivat E, Rouanet J, Auzeloux P, Sas N, Jouberton E, Levesque S, Billoux T, Mansard S, Molnar I, Chanchou M, Fois G, Maigne L, Chezal JM, Miot-Noirault E, D'Incan M, Durando X, Cachin F. Phase I study of [131I] ICF01012, a targeted radionuclide therapy, in metastatic melanoma: MELRIV-1 protocol. BMC Cancer. 2022 Apr 15;22(1):417. doi: 10.1186/s12885-022-09495-3. PMID 35428211