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

NCT07287748 | Recruiting Phase 1 DMC

• 2 other identifiers: af-001THjRCT2031250472
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

DTC - Differentiated Thyroid Cancer

Keywords

DTC; At211; alpha particle-emitting radiopharmaceutical

Outcome Measures

Primary Outcomes (2)

• Ph1a: DLT (Dose-limiting toxicity ) based on Japanese translation of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Japan Clinical Oncology Group (JCOG) version

  DLT evaluation criteria: 1. Grade ≥4\* hematologic toxicity that persists for at least 7 days 2. Febrile neutropenia regardless of duration 3. Grade ≥3\* thrombocytopenia associated with a bleeding tendency or that requires platelet transfusions 4. Anemia that requires red blood cell transfusions 5. Neutropenia associated with infection 6. Grade ≥3\* non-hematologic toxicity that persists for at least 7 days and does not improve with symptomatic treatment, with the following exceptions: * Toxicities that can be controlled to Grade ≤2\* with maximum supportive herapy * Those due to the progression of the primary tumor \[\*: Grades as defined in CTCAE v.5.0 (Japanese translation) JCOG version\]

  4 weeks

• Ph1b: Assessment of tumor reduction effect on MRI or CT scan images

  Using the "Revised version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 (Japanese translation of JCOG version 1.0)" as a reference.

  24 weeks

Study Arms (1)

[211At]NaAt

EXPERIMENTAL

Ph1a: single dose, Ph1b: mutiple dose

Drug: [211At]NaAt

Interventions

[211At]NaAt DRUG

MTD or MTD-1 level to be tested

[211At]NaAt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Alpha Fusion Inc.: lead

Study Sites (1)

National Cancer Center Hospital East

Kashiwa, Japan

RECRUITING

Study Officials

• Tahara, Chief

  National Cancer Center Hospital East

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alpha Fusion Clinical Development

CONTACT

+81335185330; development@alpha-fusion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1a, Phase 1b

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)