Actively Recruiting
A Phase I Trial of the Alpha Particle-emitting Radiopharmaceutical Af-001 in Patients With Differentiated Thyroid Cancer
Led by Alpha Fusion Inc. · Updated on 2025-12-31
38
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating af-001, an alpha particle-emitting radiopharmaceutical, in patients with differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) who have undergone total thyroidectomy. The study focuses on patients with radically unresectable, recurrent, or metastatic disease that is either resistant or intolerant to standard treatments, or who have not previously received radioactive iodine therapy. This Phase I trial aims to find safe dosage levels and assess tumor response. The trial has two parts: Part Ia involves escalating doses of a single intravenous af-001 administration to determine safety, tolerability, and the maximum tolerated dose (MTD). Part Ib is a randomized study where patients receive multiple doses at either the MTD or one dose level below it (MTD-1). Ten patients will be assigned to each of the two treatment arms using a stratified randomization based on metastasis sites. Participants will undergo monitoring for dose-limiting toxicities over 4 weeks in Part Ia and tumor size assessments via MRI or CT scans over 24 weeks in Part Ib. Eligibility requires stable health with an ECOG performance status of 0 to 2 and an expected survival of at least 6 months. Safety is closely observed, and the study runs from 2026 to 2028, led by Alpha Fusion Inc.
CONDITIONS
Brief Title
A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with differentiated thyroid cancer (papillary or follicular carcinoma) after total thyroidectomy
- Patients with radically unresectable, recurrent, or metastatic disease refractory to or intolerant of standard therapy (Part Ia)
- Patients with radically unresectable, recurrent, or metastatic disease who are radioactive iodine (RAI) naive (Part Ib)
- Patients with measurable lesions (Part Ib)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Stable general condition
- Expected survival of at least 6 months based on clinical evaluation
You will not qualify if you...
- Patients needing to preserve fertility
- Pregnant or breastfeeding females, or patients and their partners unable to use appropriate contraception
- Patients with active multiple cancers or ectopic double cancers within 3 years
- Patients with uncontrolled active infections
- Patients positive for hepatitis B surface antigen, hepatitis C virus antibodies, or HIV antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants receive the investigational drug [211At]NaAt at either the maximum tolerated dose (MTD) or one dose level below the MTD. This includes a single dose in Part Ia and multiple doses in Part Ib.
Multiple visits during treatment as per trial schedule
Trial Site Locations
Total: 1 location
1
National Cancer Center Hospital East
Kashiwa, Japan
Actively Recruiting
Research Team
A
Alpha Fusion Clinical Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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