Actively Recruiting
Phase I Study of Af-001 Treatment for Patients With Differentiated Thyroid Cancer Unresponsive to Standard Therapy
Led by Alpha Fusion Inc. · Updated on 2025-12-31
38
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
A
Alpha Fusion Clinical Development
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