悪性腹水を伴うマイクロサテライト安定進行消化器癌患者に対するGAIA-102腹腔内投与

基本情報

NCT ID: NCT05438459
ステータス: 募集中
試験のフェーズ: 第1/第2相
試験タイプ: 介入
目標被験者数: 130
治験依頼者名: Kyushu University

概要

Phase I Part : Confirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part. Phase II Part : Research the efficacy and safety of as a monotherapy or GAIA-102 and pembrolizumab for advanced gastrointestinal cancer of microsatellite stable with malignant ascites at the recommended dose of GAIA-102 decided in the Phase I part.

対象疾患

Gastric CancerPancreatic Cancer

介入

Phase I part(BIOLOGICAL)

Phase II part(BIOLOGICAL)

依頼者（Sponsor）

Toho University - Omori Medical Center(UNKNOWN)

Kindai University Hospital(UNKNOWN)

Kansai Medical University Hospital(UNKNOWN)

Jichi Medical University(OTHER)

Kyushu University(OTHER)

Teikyo University Hospital(UNKNOWN)

Kyushu Cancer Center(UNKNOWN)

Gaia Biomedicine(INDUSTRY)

実施施設 (1)

九州大学病院

Fukuoka, Fukuoka, Japan(RECRUITING)