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

Start Date27 Jul 2020

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT03604445

/ TerminatedPhase 1

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.

Start Date08 Aug 2018

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with BI-905677

100 Translational Medicine associated with BI-905677

100 Patents (Medical) associated with BI-905677

Literatures (Medical) associated with BI-905677

01 Nov 2024·ESMO Open

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

Article

Author: 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 ; Eskens, F ; Pronk, L

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 Deals associated with BI-905677

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	United States	Boehringer Ingelheim GmbH	08 Aug 2018
Advanced Malignant Solid Neoplasm	Phase 1	Spain	Boehringer Ingelheim GmbH	08 Aug 2018
Advanced Malignant Solid Neoplasm	Phase 1	Netherlands	Boehringer Ingelheim GmbH	08 Aug 2018
Advanced Malignant Solid Neoplasm	Phase 1	Japan	Boehringer Ingelheim GmbH	08 Aug 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03604445 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	37	BI 905677 (BI 905677 0.05 mg/kg)	qakvosyvpo(nfmbvxjplj) = fqvkyqlsfn cunzncftwg (bmxhdavmph, tcqbndlcbb - tnfiuscfxu) View more	-	04 Mar 2024
NCT03604445 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	37	BI 905677 (BI 905677 0.1 mg/kg)	qakvosyvpo(nfmbvxjplj) = ncokjcxefo cunzncftwg (bmxhdavmph, weatfxegxz - ygjsstcjvu) View more	-	04 Mar 2024
NCT03604445 (AACR2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	37	BI 905677	(ngcubgzqyb) = hcuulcgzqe jevalbvrvd (atpmrjxbgr ) View more	Positive	15 Jun 2022

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