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A Phase I trial of the alpha particle-emitting radiopharmaceutical, af-001, in patients with
differentiated thyroid cancer (papillary carcinoma, follicular carcinoma)

A Phase I trial of af-001 in patients with differentiated thyroid cancer (papillary and follicular
carcinoma)

Ishida Nobuo

Alpha Fusion Inc.

12KANDA #406,2-3-12 Kandasudacho, Chiyoda-ku, Tokyo, Japan

development@alpha-fusion.com

Kitajima Hiroaki

Alpha Fusion Inc.

12KANDA #406,2-3-12 Kandasudacho, Chiyoda-ku, Tokyo, Japan

+81-3-3518-5330

development@alpha-fusion.com

Pending

Oct. 30, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

<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.

<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.

Both

Differentiated thyroid cancer (papillary carcinoma, follicular carcinoma).

af-001 will be administered intravenously as a single or multiple dose.

<Part Ia>
(1) Safety evaluations (Adverse events, Adverse drug reaction, Abnormal laboratory test result).
(2) Dose-limiting toxicities (DLTs).

<Part Ib>
(1) Efficacy evaluations: Tumor shrinkage assessment.
(2) Safety evaluations (Adverse events, Adverse drug reaction, Abnormal laboratory test result).

<Part Ia>
(1) Secondary endpoints related to safety.
(2) Evaluation of pharmacokinetic parameters.
(3) Evaluation of biodistribution imaging and absorbed dose using a gamma camera.
(4) Preliminary efficacy evaluations.
1) Tumor shrinkage assessment.
2) Tumor markers (thyroglobulin in blood) over time.

<Part Ib>
(1) Duration of response.
(2) Tumor markers (thyroglobulin in blood).
(3) Changes in [131I] NaI uptake.
(4) Progression-free survival at Month 12.

Oct. 06, 2025

No

none