分化型甲状腺癌患者を対象としたAf-001の第I相試験

基本情報

NCT ID

NCT07287748

ステータス

募集中

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

38

治験依頼者名

Alpha Fusion Inc.

概要

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)

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)