Thyroid CancerPhase 1NCT05275946
Targeted Alpha Therapy Using Astatine (At-211) Against Differentiated Thyroid Cancer
A Phase 1 study testing Targeted alpha therapy in people with Thyroid Cancer, run by Osaka University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Targeted alpha therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteJapan
- Study dates
- 20 Nov 2021to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with differentiated thyroid cancer (papillary cancer, follicular cancer) after total thyroidectomy who meet the following conditions (1) resistance to standard treatment or (2) difficulty in continuing standard treatment (1) Patients who are refractory to standard treatment such as 131I-NaI treatment Insufficient therapeutic effect after 3 or more 131I-NaI treatments. 131I-NaI treatment resistance and difficulty in performing or continuing tyrosine kinase inhibitor (TKI) treatment (2) Patients who have difficulty continuing standard treatment such as 131I-NaI treatment Ablation for residual thyroid or 131I-NaI treatment for relapsed / metastatic lesions has been performed, but relapsed / metastatic lesions were observed at the time of participation in this study, and 131I-NaI is the standard treatment. If it is difficult to continue treatment or if local radiation therapy (including addition) is not indicated (if it is not 131I-NaI treatment resistant, TKI treatment is not indicated).
- Patients aged 18 years or older at the time of consent acquisition
- Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
- Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings
- Patients with no or controlled brain metastases with symptoms
- Patients with no clinically significant abnormal findings in electrocardiogram, respiratory rate, and blood oxygen saturation within 30 days before registration
- Patients whose laboratory values within 30days before the enrollment are within the range specified in the protocol
- Patients who thoroughly listened to the explanation of the clinical trial, agreed to the examination, visit during the observation period and follow-up survey, contraception during the clinical trial period, etc. according to the clinical trial protocol, and signed the consent document.
Who cannot join
- Patients who need fertility preservation
- Pregnant or potentially pregnant women, lactating patients
- Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less)
- Patients who received other investigational or unapproved drugs within 5 weeks prior to enrollment
- Patients who received chemotherapy, immunotherapy or radiation therapy within 8 weeks prior to enrollment in this study
- Patients with uncontrollable active infections
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- HBsAg positive, HCV antibody positive or HIV antibody positive patients
- Patients with mental illness or psychiatric symptoms who are judged to be difficult to participate in clinical trials
- Other patients who are judged to be inappropriate by the investigator, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Investigator-initiated Clinical Trial in Patients With Differentiated Thyroid Cancer (Papillary Cancer, Follicular Cancer) by the Targeted Alpha Therapy Drug TAH-1005 ([211At] NaAt) (Alpha-T1 Study)
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.
Read the detailed description
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.
- Conditions
- Thyroid Cancer
- Being tested
- Targeted alpha therapy
- Keywords
- Targeted alpha therapy, Astatine (At-211)
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted alpha therapyDrug
Single intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | Not described Receives: Drug: Targeted alpha therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events as assessed by CTCAE v5.0
Type, severity, frequency of occurrence and duration of adverse events
Measured: 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.
- Grade 3 * hematological toxicity that lasts for 7 days or more
- Hematological toxicity of Grade 4 * or higher regardless of duration
- Febrile neutropenia regardless of duration
- Thrombocytopenia with bleeding tendency or requiring platelet transfusion
- Anemia requiring red blood cell transfusion
- Neutropenia with infection
- Non-hematological toxicity of Grade 3 * or higher that does not improve with symptomatic treatment and lasts for 7 days or longer. However, the following are excluded.
- Abnormal laboratory test values that are not clinically significant
- Toxicity that can be controlled to Grade 2 * or less with maximum supportive care
- Due to exacerbation of the underlying disease (*: Grade specified in CTCAE v.5.0J COG version)
Measured: within 4 weeks after administration
Secondary outcomes (28)
Blood pressure
Systolic and diastolic blood pressure (mmHg)
Measured: within 4 weeks after administration
Heart rate
Pulse (bpm)
Measured: within 4 weeks after administration
Blood oxygen saturation
Percutaneous oxygen saturation (%)
Measured: within 4 weeks after administration
Respiratory rate
Respiratory rate (times/min)
Measured: within 4 weeks after administration
Body temperature
Body temperature (°C)
Measured: within 4 weeks after administration
Body weight
Weight (kg)
Measured: within 4 weeks after administration
Symptoms and examination findings
Subjective symptoms and medical examination findings
Measured: 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)
Measured: 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)
Measured: within 4 weeks after administration
Urinalysis
Urinary protein, urine sugar, urineous blood, urobilinogen (qualitative test)
Measured: within 4 weeks after administration
12-lead ECG
Presence or absence of abnormal findings in waveform
Measured: within 4 weeks after administration
Pharmacokinetic parameters 1)
AUC (Area under the plasma concentration versus time curve, Bq·min/mL)
Measured: until 24 hours after administration
Pharmacokinetic parameters 2)
AUC / D (Area under the plasma concentration versus time curve divided by injected dose, min/mL)
Measured: until 24 hours after administration
Pharmacokinetic parameters 3)
Cmax (Peak plasma concentration, Bq/mL)
Measured: until 24 hours after administration
Pharmacokinetic parameters 4)
Cmax / D (Peak plasma concentration divided by injected dose, /mL)
Measured: until 24 hours after administration
Pharmacokinetic parameters 5)
Tmax (Time to maximum plasma concentration, min)
Measured: until 24 hours after administration
Pharmacokinetic parameters 6)
T1 / 2 (Time from Tmax to half of maximum plasma concentration, min)
Measured: until 24 hours after administration
Pharmacokinetic parameters 7)
CL (Clearance, L/hr/kg)
Measured: until 24 hours after administration
Pharmacokinetic parameters 8)
Vss (Volume of distribution in steady state, L/kg)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: until 24 hours after administration
Residence time of major organs
Residence time (hr) of each organ
Measured: until 24 hours after administration
Absorbed dose of major organs
Absorbed dose (mGy / MBq) of each organ
Measured: 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)
Measured: 3 and 6 months after administration
Preliminary effectiveness assessment 2)
Evaluation of uptake change in diagnostic [131I] NaI scans: CR , PR, SD, or PD
Measured: 3 and 6 months after administration
Preliminary effectiveness assessment 3)
Evaluation of changes in tumor markers: blood thyroglobulin (ng/mL)
Measured: 3 and 6 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start20 Nov 2021
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadashi Watabe, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275946
- Sponsor's protocol ID
- AT1-001
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2022
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Investigator-initiated Clinical Trial in Patients With Differentiated Thyroid Cancer (Papillary Cancer, Follicular Cancer) by the Targeted Alpha Therapy Drug TAH-1005 ([211At] NaAt) (Alpha-T1 Study)
- ClinicalTrials.gov ID
- NCT05275946
- Acronym / sponsor ID
- AT1-001
- Conditions
- Thyroid Cancer
- Keywords
- Targeted alpha therapy, Astatine (At-211)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Drug: Targeted alpha therapy |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients with differentiated thyroid cancer (papillary cancer, follicular cancer) after total thyroidectomy who meet the following conditions (1) resistance to standard treatment or (2) difficulty in continuing standard treatment (1) Patients who are refractory to standard treatment such as 131I-NaI treatment Insufficient therapeutic effect after 3 or more 131I-NaI treatments. 131I-NaI treatment resistance and difficulty in performing or continuing tyrosine kinase inhibitor (TKI) treatment (2) Patients who have difficulty continuing standard treatment such as 131I-NaI treatment Ablation for residual thyroid or 131I-NaI treatment for relapsed / metastatic lesions has been performed, but relapsed / metastatic lesions were observed at the time of participation in this study, and 131I-NaI is the standard treatment. If it is difficult to continue treatment or if local radiation therapy (including addition) is not indicated (if it is not 131I-NaI treatment resistant, TKI treatment is not indicated).
- Patients aged 18 years or older at the time of consent acquisition
- Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
- Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings
- Patients with no or controlled brain metastases with symptoms
Key exclusion criteria (9 listed)
- Patients who need fertility preservation
- Pregnant or potentially pregnant women, lactating patients
- Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less)
- Patients who received other investigational or unapproved drugs within 5 weeks prior to enrollment
- Patients who received chemotherapy, immunotherapy or radiation therapy within 8 weeks prior to enrollment in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted alpha therapySingle intravenous administration | Drug | Treatment group |
Primary outcome
Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From the start of iodine restriction to 6 months after administration
Type, severity, frequency of occurrence and duration of adverse events
Dose Limiting Toxicity
Time frame: within 4 weeks after administration
Toxicity is defined as one or more of the following items for which a causal relationship with the investigational drug cannot be ruled out. 1. Grade 3 * hematological toxicity that lasts for 7 days or more 2. Hematological toxicity of Grade 4 * or higher regardless of duration 3. Febrile neutropenia regardless of duration 4. Thrombocytopenia with bleeding tendency or requiring platelet transfusion 5. Anemia requiring red blood cell transfusion 6. Neutropenia with infection 7. Non-hematological toxicity of Grade 3 * or higher that does not improve with symptomatic treatment and lasts for 7 days or longer. However, the following are excluded. * Abnormal laboratory test values that are not clinically significant * Toxicity that can be controlled to Grade 2 * or less with maximum supportive care * Due to exacerbation of the underlying disease (*: Grade specified in CTCAE v.5.0J COG version)
28 secondary outcomes
Blood pressure
Time frame: within 4 weeks after administration
Heart rate
Time frame: within 4 weeks after administration
Blood oxygen saturation
Time frame: within 4 weeks after administration
Respiratory rate
Time frame: within 4 weeks after administration
Body temperature
Time frame: within 4 weeks after administration
Body weight
Time frame: within 4 weeks after administration
Symptoms and examination findings
Time frame: within 4 weeks after administration
Hematological examination
Time frame: within 4 weeks after administration
Blood biochemical test
Time frame: within 4 weeks after administration
Urinalysis
Time frame: within 4 weeks after administration
12-lead ECG
Time frame: within 4 weeks after administration
Pharmacokinetic parameters 1)
Time frame: until 24 hours after administration
Pharmacokinetic parameters 2)
Time frame: until 24 hours after administration
Pharmacokinetic parameters 3)
Time frame: until 24 hours after administration
Pharmacokinetic parameters 4)
Time frame: until 24 hours after administration
Pharmacokinetic parameters 5)
Time frame: until 24 hours after administration
Pharmacokinetic parameters 6)
Time frame: until 24 hours after administration
Pharmacokinetic parameters 7)
Time frame: until 24 hours after administration
Pharmacokinetic parameters 8)
Time frame: until 24 hours after administration
Excretion 1) urinary
Time frame: until 24 hours after administration
Excretion 2) fecal
Time frame: until 24 hours after administration
Excretion 3) exhaled
Time frame: until 24 hours after administration
Radioactivity concentration in major organs
Time frame: until 24 hours after administration
Residence time of major organs
Time frame: until 24 hours after administration
Absorbed dose of major organs
Time frame: until 24 hours after administration
Preliminary effectiveness assessment 1)
Time frame: 3 and 6 months after administration
Preliminary effectiveness assessment 2)
Time frame: 3 and 6 months after administration
Preliminary effectiveness assessment 3)
Time frame: 3 and 6 months after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Targeted alpha therapy in people with Thyroid Cancer, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events as assessed by CTCAE v5.0 (time frame: From the start of iodine restriction to 6 months after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.