進行固形腫瘍患者を対象とした抗CEACAM5 ADC M9140の試験（PROCEADE PanTumor）

基本情報

NCT ID: NCT06710132
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: 250
治験依頼者名: EMD Serono

概要

The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as monotherapy or in combination treatments in adult participants with locally advanced/metastatic CEACAM5 expressing tumors. There will be 3 substudies under this Master Protocol that may be conducted in parallel. * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Gastric Cancer (Substudy GC); * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer (Substudy NSCLC); * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC).

対象疾患

固形腫瘍胃がん非小細胞肺がん（NSCLC）膵臓癌膵管腺癌（PDAC）

介入

M9140(DRUG)

依頼者（Sponsor）

Merck Healthcare Kgaa, Darmstadt, Germany, An Affiliate Of Merck Kgaa, Darmstadt, Germany(INDUSTRY)

Emd Serono Research & Development Institute(INDUSTRY)

Merck Kgaa, Darmstadt, Germany(INDUSTRY)

実施施設 (8)

公益財団法人がん研究会　有明病院

Kōtoku, Japan(RECRUITING)

久留米大学病院

Kurume-shi, Japan(RECRUITING)

新潟県立がんセンター新潟病院

Niigata, Japan(RECRUITING)

近畿大学病院

Osakasayama-shi, Japan(RECRUITING)

独立行政法人国立病院機構北海道がんセンター

Sapporo, Japan(RECRUITING)

公立大学法人　奈良県立医科大学附属病院

Kashihara-shi, Japan(RECRUITING)

国立研究開発法人国立がん研究センター中央病院

Chūōku, Japan(RECRUITING)

栃木県済生会宇都宮病院

Kumamoto, Japan(RECRUITING)