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

NCT ID: NCT07287748

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-07-31

Brief Summary

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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)

Detailed Description

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The Part Ia is a dose escalation part. The Part Ib is a parallel-group comparative study part based on the MTD determined in Part Ia, in which 10 patients each will be randomly assigned to one of two treatment arms, at the MTD for af-001 or the MTD-1 dose level. Patients will be randomly assigned by the enrollment system (allocated at a ratio of 1:1). Random assignment will be performed using the stratified permuted block method. The stratification factor will be the site(s) of metastases.

Conditions

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DTC - Differentiated Thyroid Cancer

Keywords

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DTC At211 alpha particle-emitting radiopharmaceutical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Phase 1a, Phase 1b
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[211At]NaAt

Ph1a: single dose, Ph1b: mutiple dose

Group Type EXPERIMENTAL

[211At]NaAt

Intervention Type DRUG

MTD or MTD-1 level to be tested

Interventions

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[211At]NaAt

MTD or MTD-1 level to be tested

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alpha Fusion Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tahara, Chief

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center Hospital East

Locations

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National Cancer Center Hospital East

Kashiwa, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Alpha Fusion Clinical Development

Role: CONTACT

Phone: +81335185330

Email: [email protected]

Other Identifiers

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jRCT2031250472

Identifier Type: OTHER

Identifier Source: secondary_id

af-001TH

Identifier Type: -

Identifier Source: org_study_id