An open label Phase I Positron Emission Tomography Imaging study to investigate the bio-distribution and tumor uptake of [89Zr]Zr-BI 905677 in patients with advanced tumors harbouring an RNF43 mutation or R-Spondin Fusion - A study how BI 905677 acts in tumors of patients with cancer

开始日期2020-07-27

申办/合作机构

Boehringer Ingelheim GmbH

NCT03604445

/ Terminated临床1期

An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours

This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer.
One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.

开始日期2018-08-08

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 BI-905677 相关的临床结果

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100 项与 BI-905677 相关的转化医学

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100 项与 BI-905677 相关的专利（医药）

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项与 BI-905677 相关的文献（医药）

2024-11-01·ESMO Open

A phase I dose-escalation study of LRP5/6 antagonist BI 905677 in patients with advanced solid tumors

Article

作者: Argilés, G ; Doi, T ; Kuboki, Y ; El-Khoueiry, A ; de Jonge, M J A ; Yaeger, R ; Tabernero, J ; Bertulis, J ; Lenz, H-J ; Nazabadioko, S ; Pronk, L ; Eskens, F

BACKGROUNDAberrant Wnt pathway signaling has been implicated in the development of many cancers. Targeting of low-density lipoprotein receptor-related protein 5/6 (LRP5/6) co-receptors inhibits Wnt signaling and may be a novel therapy. BI 905677 is an LRP5/6 antagonist that has demonstrated preclinical antitumor activity.PATIENTS AND METHODSThis (NCT03604445) was a phase I, dose-escalation study evaluating BI 905677 for patients with advanced solid tumors over two dosing schedules (A: i.v. infusion every 3 weeks, 3-week cycles; B: i.v. infusion every 2 weeks, 4-week cycles). Adult patients were eligible if they had exhausted treatment options and had an Eastern Cooperative Oncology Group performance status of 0-1. The primary endpoints were the maximum tolerated dose (MTD) and safety. Other endpoints were pharmacokinetics, pharmacodynamics, and efficacy.RESULTSIn total, 37 patients received BI 905677 over nine dose cohorts (0.05-3.6 mg/kg/every 3 weeks). Dose-limiting toxicities were only reported during cycle 1 in the 3.6 mg/kg cohort and the MTD was established at 2.8 mg/kg every 3 weeks. Enrollment for schedule B was not pursued. The most frequently reported adverse events were diarrhea (35.1%), vomiting (21.6%), and C-telopeptide increase (18.9%). All patients in the 3.6 mg/kg cohort experienced a dose-limiting toxicity, suggesting a narrow therapeutic index. Paired pre-treatment and on-treatment biopsies, where available, showed decreased Axin2 expression by reverse transcriptase polymerase chain reaction with treatment, suggesting target inhibition. Best response observed was stable disease in 14 (38%) patients.CONCLUSIONThe MTD of BI 905677 was set at 2.8 mg/kg every 3 weeks. BI 905677 was well tolerated but a narrow therapeutic range and minimal efficacy led to early termination of the trial.

100 项与 BI-905677 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床1期	西班牙	Boehringer Ingelheim GmbH	2018-08-08
晚期恶性实体瘤	临床1期	荷兰	Boehringer Ingelheim GmbH	2018-08-08
晚期恶性实体瘤	临床1期	日本	Boehringer Ingelheim GmbH	2018-08-08
晚期恶性实体瘤	临床1期	美国	Boehringer Ingelheim GmbH	2018-08-08

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03604445 (CTgov)	临床1期	晚期恶性实体瘤	37	BI 905677 (BI 905677 0.05 mg/kg)	淵夢襯淵夢獵積廠醖壓(簾製淵簾鏇齋鑰衊積構) = 齋夢鹹膚憲蓋蓋範襯餘鏇積鬱餘齋積憲糧製壓 (鑰糧廠蓋窪糧窪範廠鬱, 憲選齋鹽願製鹽鹹遞網 ~ 夢構繭繭築鏇淵餘築鏇) 更多	-	2024-03-04
NCT03604445 (CTgov)	临床1期	晚期恶性实体瘤	37	BI 905677 (BI 905677 0.1 mg/kg)	淵夢襯淵夢獵積廠醖壓(簾製淵簾鏇齋鑰衊積構) = 齋選選繭醖選鬱糧範憲鏇積鬱餘齋積憲糧製壓 (鑰糧廠蓋窪糧窪範廠鬱, 顧窪蓋壓夢憲網築糧網 ~ 獵鏇膚鏇遞糧膚衊鏇膚) 更多	-	2024-03-04
NCT03604445 (AACR2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	37	BI 905677	(鑰遞觸齋憲遞積鹽願齋) = 糧鹽餘憲糧鑰遞壓構餘淵積糧獵衊觸衊網醖廠 (製網衊製淵鏇製衊廠網 ) 更多	积极	2022-06-15