腫瘍非依存型精密免疫腫瘍学および体細胞標的化(TAPISTRY)プラットフォーム研究
基本情報
- NCT ID
- NCT04589845
- 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
- 920
- 治験依頼者名
- Hoffmann-La Roche
概要
TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.
対象疾患
介入
依頼者(Sponsor)
実施施設 (2)
近畿大学東洋医学研究所附属診療所
Osaka, Japan(COMPLETED)
国立研究開発法人国立がん研究センター中央病院
Chiba, Japan(WITHDRAWN)