Targeted Alpha Therapy Using Astatine (At-211) Against Differentiated Thyroid Cancer

April 19, 2025 updated by: Tadashi Watabe, Osaka University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Suita, Japan, 565-0871
        • Osaka University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. Patients aged 18 years or older at the time of consent acquisition
  3. Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
  4. Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings
  5. Patients with no or controlled brain metastases with symptoms
  6. Patients with no clinically significant abnormal findings in electrocardiogram, respiratory rate, and blood oxygen saturation within 30 days before registration
  7. Patients whose laboratory values within 30days before the enrollment are within the range specified in the protocol
  8. 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.

Exclusion Criteria:

  1. Patients who need fertility preservation
  2. Pregnant or potentially pregnant women, lactating patients
  3. Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less)
  4. Patients who received other investigational or unapproved drugs within 5 weeks prior to enrollment
  5. Patients who received chemotherapy, immunotherapy or radiation therapy within 8 weeks prior to enrollment in this study
  6. Patients with uncontrollable active infections
  7. HBsAg positive, HCV antibody positive or HIV antibody positive patients
  8. Patients with mental illness or psychiatric symptoms who are judged to be difficult to participate in clinical trials
  9. Other patients who are judged to be inappropriate by the investigator, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Treatment group
Drug: Targeted alpha therapy
Single intravenous administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From the start of iodine restriction to 6 months after administration
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)
within 4 weeks after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: within 4 weeks after administration
Systolic and diastolic blood pressure (mmHg)
within 4 weeks after administration
Heart rate
Time Frame: within 4 weeks after administration
Pulse (bpm)
within 4 weeks after administration
Blood oxygen saturation
Time Frame: within 4 weeks after administration
Percutaneous oxygen saturation (%)
within 4 weeks after administration
Respiratory rate
Time Frame: within 4 weeks after administration
Respiratory rate (times/min)
within 4 weeks after administration
Body temperature
Time Frame: within 4 weeks after administration
Body temperature (°C)
within 4 weeks after administration
Body weight
Time Frame: within 4 weeks after administration
Weight (kg)
within 4 weeks after administration
Symptoms and examination findings
Time Frame: within 4 weeks after administration
Subjective symptoms and medical examination findings
within 4 weeks after administration
Hematological examination
Time Frame: within 4 weeks after administration
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
Time Frame: within 4 weeks after administration
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
Time Frame: within 4 weeks after administration
Urinary protein, urine sugar, urineous blood, urobilinogen (qualitative test)
within 4 weeks after administration
12-lead ECG
Time Frame: within 4 weeks after administration
Presence or absence of abnormal findings in waveform
within 4 weeks after administration
Pharmacokinetic parameters 1)
Time Frame: until 24 hours after administration
AUC (Area under the plasma concentration versus time curve, Bq·min/mL)
until 24 hours after administration
Pharmacokinetic parameters 2)
Time Frame: until 24 hours after administration
AUC / D (Area under the plasma concentration versus time curve divided by injected dose, min/mL)
until 24 hours after administration
Pharmacokinetic parameters 3)
Time Frame: until 24 hours after administration
Cmax (Peak plasma concentration, Bq/mL)
until 24 hours after administration
Pharmacokinetic parameters 4)
Time Frame: until 24 hours after administration
Cmax / D (Peak plasma concentration divided by injected dose, /mL)
until 24 hours after administration
Pharmacokinetic parameters 5)
Time Frame: until 24 hours after administration
Tmax (Time to maximum plasma concentration, min)
until 24 hours after administration
Pharmacokinetic parameters 6)
Time Frame: until 24 hours after administration
T1 / 2 (Time from Tmax to half of maximum plasma concentration, min)
until 24 hours after administration
Pharmacokinetic parameters 7)
Time Frame: until 24 hours after administration
CL (Clearance, L/hr/kg)
until 24 hours after administration
Pharmacokinetic parameters 8)
Time Frame: until 24 hours after administration
Vss (Volume of distribution in steady state, L/kg)
until 24 hours after administration
Excretion 1) urinary
Time Frame: until 24 hours after administration
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
Time Frame: until 24 hours after administration
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
Time Frame: until 24 hours after administration
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
Time Frame: until 24 hours after administration
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
Time Frame: until 24 hours after administration
Residence time (hr) of each organ
until 24 hours after administration
Absorbed dose of major organs
Time Frame: until 24 hours after administration
Absorbed dose (mGy / MBq) of each organ
until 24 hours after administration
Preliminary effectiveness assessment 1)
Time Frame: 3 and 6 months after administration
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)
Time Frame: 3 and 6 months after administration
Evaluation of uptake change in diagnostic [131I] NaI scans: CR , PR, SD, or PD
3 and 6 months after administration
Preliminary effectiveness assessment 3)
Time Frame: 3 and 6 months after administration
Evaluation of changes in tumor markers: blood thyroglobulin (ng/mL)
3 and 6 months after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Osaka University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT1-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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