稀な上皮成長因子受容体（EGFR）またはヒト上皮成長因子受容体2（HER2）の活性化変異を含む進行性または転移性非小細胞肺癌（NSCLC）患者におけるフルモネルチニブの研究

基本情報

NCT ID: NCT05364073
ステータス: 実施中（募集終了）
試験のフェーズ: 第1相
試験タイプ: 介入
目標被験者数: 160
治験依頼者名: ArriVent BioPharma, Inc.

概要

This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

対象疾患

Non-Small Cell Lung Cancer (NSCLC)Metastatic Non-Small Cell Lung CancerAdvanced Non-Small Cell Lung CancerHER2 Exon 20 MutationsEGFR Exon 20 MutationsEGFR Uncommon Mutations, Including G719X and S768I

介入

Furmonertinib(DRUG)

依頼者（Sponsor）

Arrivent Biopharma(INDUSTRY)

実施施設 (4)

Arrivent Investigative Site

Koto-Ku, Tokyo, Japan

近畿大学東洋医学研究所附属診療所

Ōsaka-sayama, Osaka, Japan

Arrivent Investigative Site

Chūō, Tokyo, Japan

ArriVent Investigative Site

Chiba, Chiba, Japan