Here is the design of a clinical trial:

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

Included conditions:
- Melanoma

Study Armgroups:
- {'label': 'therapeutic dose activity (level 1)', 'type': 'EXPERIMENTAL', '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)']}
- {'label': 'therapeutic dose activity (level 2)', 'type': 'EXPERIMENTAL', '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)']}
- {'label': 'therapeutic dose activity (level 3)', 'type': 'EXPERIMENTAL', 'description': '\\[131\\]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)', 'interventionNames': ['Drug: [131I]ICF01012 (therapeutic dose level 3)']}
- {'label': 'therapeutic dose activity (level 4)', 'type': 'EXPERIMENTAL', 'description': '\\[131\\]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)', 'interventionNames': ['Drug: [131I]ICF01012 (therapeutic dose level 4)']}

Interventions:
- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 1)', 'description': '* 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)\n* 1 therapeutic injection (D11) at a dose of 800 MBq/m²', 'armGroupLabels': ['therapeutic dose activity (level 1)']}
- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 2)', 'description': '* 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)\n* 1 therapeutic injection (D11) at a dose of 1600 MBq/m²', 'armGroupLabels': ['therapeutic dose activity (level 2)']}
- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 3)', 'description': '* 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)\n* 1 therapeutic injection (D11) at a dose of 2700 MBq/m²', 'armGroupLabels': ['therapeutic dose activity (level 3)']}
- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 4)', 'description': '* 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)\n* 1 therapeutic injection (D11) at a dose of 4000 MBq/m²', 'armGroupLabels': ['therapeutic dose activity (level 4)']}

Primary Outcomes:
- {'measure': 'Evaluation of the recommended therapeutic dose of [131I] ICF01012', 'description': 'defined as the highest dose at which the percentage of DLT (dose limiting toxicity) is less than 33%. The DLT is defined as:\n\n* all non hematologic toxicities NCI-CTC grade 3-4 except for alopecia, nausea, vomiting and fever that can be controlled by appropriate measures.\n* hematologic toxicities as thrombopenia and anemia of grade 4, neutropenia of grade 4 for more than 5 days, thrombopenia of grade 3 with bleeding and all other hematologic toxicities of grade 3 clinically significant of more than 3 weeks', 'timeFrame': 'Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT'}

Please estimate the sample size based on the assumption: 
Using a CRM model with 4 dose levels, with cohorts of one patient by dose level and at least 6 patients at the recommended dose
Sample size
          Using a CRM model with 4 dose levels, i.e. with cohorts of one patient by dose level and at least 6 patients at the recommended dose, a minimum of 6 patients and a maximum of 18 patients should be included in the âtherapeutic partâ. Sample size calculation for the selection part is based on the hypothesis that 50% of patients will have at least an [131I]ICF01012 lesion uptake as observed with BZA2 in phase III study [8] and thus be eligible for the therapeutic part. Therefore, between 12 to 36 patients will be enrolled in the selection part in order to ensure the necessary sample size for the therapeutic part (between 6 to 18).