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New Alpha-Particle drug targets Hard-to-Treat thyroid cancer

NCT ID NCT07287748

Disease control Sponsor: Alpha Fusion Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new radioactive drug called Af-001 in people with advanced differentiated thyroid cancer that cannot be removed by surgery or has spread. The study has two parts: first, to find the safest dose, and second, to see if multiple doses can shrink tumors. About 38 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Af-001 (a radioactive drug that emits alpha particles)
What this could lead to
If successful, this could provide a new treatment option for people with advanced thyroid cancer that has stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 38 participants, so safety and effectiveness are not yet proven. The radioactive drug may cause serious side effects like low blood counts or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \<Ia part\> * Patients with differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) after total thyroidectomy. * Patients with radically unresectable, recurrent, metastatic disease who are judged by the principal investigator or sub-investigator (hereinafter, "principal/sub-investigators") to be refractory to or intolerant of standard-of-care therapy. \<Ib part\> * Patients with radically unresectable, recurrent, metastatic disease who are RAI naive * Patients with measurable lesions. \<Ia/Ib part\> * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 and stable general condition. * Patients expected to survive for at least 6 additional months based on clinical symptoms and physical examination findings. Exclusion Criteria: \<Ia/Ib part\> * Patients who need to preserve fertility. * Females who are pregnant or may be pregnant, breastfeeding patients, or patients or their partners who cannot agree to appropriate contraception. * Patients with active multiple cancers (synchronous multiple cancers and ectopic double cancers with a disease-free period of \<=3 years). * Patients with uncontrolled active infections. * Patients who are positive for hepatitis B virus surface (HBs) antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies.

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Conditions

The condition(s) this trial relates to.

differentiated thyroid carcinoma papillary carcinoma thyroid gland follicular carcinoma thyroid gland papillary carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DTC - differentiated thyroid cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.