Open-label dose-finding trial to explore safety, pharmacokinetics, pharmacodynamics, and efficacy of BI 3706674 given orally as monotherapy in patients with unresectable metastatic KRAS wild type amplified gastric, oesophageal, and gastroesophageal-juncti

Nippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 15 人开始时间: 2023年12月12日最近更新: 2024年3月12日

试验速览

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•Patients with pathologically confirmed diagnosis of locally advanced or metastatic GAC, EAC, and GEJAC with KRAS wt amplification and documented disease progression despite at least 1 line of prior therapy
•Dose escalation part only: Patients with advanced or metastatic relapsed or refractory solid tumours of any histology with KRAS wt amplification or harbouring a KRAS G12V mutation who have exhausted treatment options known to prolong survival for their disease.
•At least one target lesion that can be measured per RECIST version 1.1 (radiated lesions do not qualify as target lesions unless there has been demonstrated progression of the lesion after completion of radiotherapy)
•Dose escalation part only: Patients with no lesions measurable per RECIST version 1.1 may be included if agreed between sponsor and investigator.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Dose confirmation part only: Willingness to undergo pre- and on-treatment tumour biopsies
•Adequate organ function as defined in Section 3.3.
•All toxicities related to previous anti-cancer therapies have resolved to <= CTCAE Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be <= CTCAE Grade 2 and amenorrhea or menstrual disorders which can be any grade)

•Previous anti-cancer chemotherapy within 3 weeks of the first administration of trial drug
•Previous anti-cancer hormonal treatment or anti-cancer immunotherapy within 2 weeks of the first administration of trial drug
•Previous treatment with RAS, MAPK or SOS1 targeting agents

Occurrence of DLTs in the MTD evaluation period

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