RecruitingPhase 1NCT07287748

A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer

A Phase I Trial of the Alpha Particle-emitting Radiopharmaceutical, Af-001, in Patients With Differentiated Thyroid Cancer


Sponsor

Alpha Fusion Inc.

Enrollment

38 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This trial consists of 2 parts, i.e., Part Ia and Ib. The Part Ia is to evaluate the safety and tolerability of a single intravenous dose of af-001 in patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) refractory to or intolerant of standard-of-care therapy, who have received total thyroidectomy, and to determine the MTD (Maximum tolerated dose). Part Ib is to evaluate the efficacy and safety of af-001 mutiple doses to patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma), who have received total thyroidectomy and are RAI naïve, randomized into two arms at the determined MTD or the MTD-1 dose level, and to determine the recommended Phase II dose (RP2D)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a new drug called Af-001 in people with differentiated thyroid cancer (a type including papillary and follicular thyroid cancer) that has come back or spread and is no longer responding to standard treatments. **You may be eligible if...** - You have papillary or follicular thyroid cancer that has been fully removed surgically - Your cancer has come back or spread and cannot be surgically removed - Your cancer is either resistant to or no longer a candidate for standard therapy (Part Ia), OR your cancer has not yet been treated with radioactive iodine (Part Ib) - You have at least one measurable tumor lesion - Your general health is reasonable (ECOG 0–2) and you are expected to survive at least 6 more months **You may NOT be eligible if...** - You have a thyroid cancer type other than papillary or follicular - Your cancer has not relapsed or spread - Your organ function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[211At]NaAt

MTD or MTD-1 level to be tested


Locations(1)

National Cancer Center Hospital East

Kashiwa, Japan

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NCT07287748


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