Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single intravenous administration of TAH-1005 is performed in patients with differentiated thyroid cancer (papillary cancer, follicular cancer) who cannot obtain therapeutic effect with standard treatment or who have difficulty in implementing and continuing standard treatment. The safety, pharmacokinetics, absorbed dose, and efficacy will be evaluated to determine the recommended dose for Phase II clinical trial.
Radioactive iodine (I-131) has long been used clinically for patients with metastatic differentiated thyroid cancer. However, some patients are refractory to repetitive I-131 treatment, despite the targeted regions showing sufficient iodine uptake. In such patients, beta-particle therapy using I-131 is inadequate and another strategy is needed using more effective radionuclide targeting the sodium/iodide symporter (NIS). Astatine (At-211) is receiving increasing attention as an alpha-emitter for targeted radionuclide therapy. At-211 is a halogen element with similar chemical properties to iodine. Alpha particles emitted from At-211 has higher linear energy transfer as compared to beta particles from I-131 and exert a better therapeutic effect by inducing DNA double strand breaks and free radical formation. Thus, targeted alpha therapy using At-211 is highly promising for the treatment of advanced differentiated thyroid cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted alpha therapy | Drug | Single intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events as assessed by CTCAE v5.0 | Type, severity, frequency of occurrence and duration of adverse events | From the start of iodine restriction to 6 months after administration |
| Dose Limiting Toxicity | Toxicity is defined as one or more of the following items for which a causal relationship with the investigational drug cannot be ruled out.
| within 4 weeks after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Systolic and diastolic blood pressure (mmHg) | within 4 weeks after administration |
| Heart rate | Pulse (bpm) | within 4 weeks after administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka University Hospital | Suita | 565-0871 | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood oxygen saturation | Percutaneous oxygen saturation (%) | within 4 weeks after administration |
| Respiratory rate | Respiratory rate (times/min) | within 4 weeks after administration |
| Body temperature | Body temperature (°C) | within 4 weeks after administration |
| Body weight | Weight (kg) | within 4 weeks after administration |
| Symptoms and examination findings | Subjective symptoms and medical examination findings | within 4 weeks after administration |
| Hematological examination | White blood cell count (/μL), red blood cell count (×10^4/μL), hemoglobin (g/dL), hematocrit (%), platelet count (×10^4/μL) | within 4 weeks after administration |
| Blood biochemical test | Total protein (g/dL), albumin (g/dL), total bilirubin (mg/dL), AST (U/L), ALT (U/L), ALP (U/L), γ-GTP (U/L), LDH (U/L), total cholesterol (mg/dL), triglyceride (mg/dL), uric acid (mg/dL), BUN (mg/dL), creatinine (mg/dL), CK (U/L), Na (mmol/L), K (mmol/L), Cl (mmol/L), Ca (mmol/L), CRP (mg/dL) | within 4 weeks after administration |
| Urinalysis | Urinary protein, urine sugar, urineous blood, urobilinogen (qualitative test) | within 4 weeks after administration |
| 12-lead ECG | Presence or absence of abnormal findings in waveform | within 4 weeks after administration |
| Pharmacokinetic parameters 1) | AUC (Area under the plasma concentration versus time curve, Bq·min/mL) | until 24 hours after administration |
| Pharmacokinetic parameters 2) | AUC / D (Area under the plasma concentration versus time curve divided by injected dose, min/mL) | until 24 hours after administration |
| Pharmacokinetic parameters 3) | Cmax (Peak plasma concentration, Bq/mL) | until 24 hours after administration |
| Pharmacokinetic parameters 4) | Cmax / D (Peak plasma concentration divided by injected dose, /mL) | until 24 hours after administration |
| Pharmacokinetic parameters 5) | Tmax (Time to maximum plasma concentration, min) | until 24 hours after administration |
| Pharmacokinetic parameters 6) | T1 / 2 (Time from Tmax to half of maximum plasma concentration, min) | until 24 hours after administration |
| Pharmacokinetic parameters 7) | CL (Clearance, L/hr/kg) | until 24 hours after administration |
| Pharmacokinetic parameters 8) | Vss (Volume of distribution in steady state, L/kg) | until 24 hours after administration |
| Excretion 1) urinary | Urine volume (mL) and radioactivity (Bq): Radioactivity and volume will be combined to report radioactivity concentration (Bq/mL). | until 24 hours after administration |
| Excretion 2) fecal | Stool weight (g) and radioactivity (Bq): Radioactivity and weight will be combined to report radioactivity concentration (Bq/g). | until 24 hours after administration |
| Excretion 3) exhaled | Exhaled volume (mL) and radioactivity (Bq): Radioactivity and volume will be combined to report radioactivity concentration (Bq/mL). | until 24 hours after administration |
| Radioactivity concentration in major organs | Changes in radioactivity concentration (Bq/mL) in major organs over time: Whole-body imaging (planar and SPECT/CT) is performed to evaluate the distribution in the body at 1 hour, 3 hours, 24 hours after the administration. | until 24 hours after administration |
| Residence time of major organs | Residence time (hr) of each organ | until 24 hours after administration |
| Absorbed dose of major organs | Absorbed dose (mGy / MBq) of each organ | until 24 hours after administration |
| Preliminary effectiveness assessment 1) | Evaluation of treatment effect on CT images by referring to the Revised RECIST guideline (version 1.1): CR (Complete response), PR (Partial response), SD (Stable disease), or PD (Progressive disease) | 3 and 6 months after administration |
| Preliminary effectiveness assessment 2) | Evaluation of uptake change in diagnostic [131I] NaI scans: CR , PR, SD, or PD | 3 and 6 months after administration |
| Preliminary effectiveness assessment 3) | Evaluation of changes in tumor markers: blood thyroglobulin (ng/mL) | 3 and 6 months after administration |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |