高悪性度非筋層浸潤性膀胱癌成人患者におけるTARA-002膀胱内注入の安全性および有効性試験

基本情報

NCT ID

NCT05951179

ステータス

募集中

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

131

治験依頼者名

Protara Therapeutics

概要

TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF. Participants will be enrolled into one of 2 cohorts: Cohort A: * Participants with CIS (± Ta/T1) who are BCG naive, or * Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: * Participants who are BCG unresponsive

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)