[Translation] A randomized, double-blind, multicenter trial to evaluate the efficacy and safety of scopolamine injection in the treatment of acute gastric or intestinal spasm-like pain compared with anisodamine

主要目的是评估百舒平（丁溴东莨菪碱）注射液对比654-II（山莨菪碱）治疗急性胃或肠痉挛样疼痛的有效性;次要目的是考察百舒平的安全性。

[Translation]

The primary objective was to evaluate the effectiveness of Basuping (scopolamine butylbromide) injection versus 654-II (anisodamine) in the treatment of acute gastric or intestinal spasm-like pain; the secondary objective was to investigate the safety of Basuping.

Start Date26 Oct 2013

Sponsor / Collaborator

Boehringer Ingelheim Shanghai Pharmaceuticals Co. Ltd.

[+1]

100 Clinical Results associated with Boehringer Ingelheim España SA

0 Patents (Medical) associated with Boehringer Ingelheim España SA

Literatures (Medical) associated with Boehringer Ingelheim España SA

25 Apr 2025·Cancer Research

Abstract CT110: An open-label, phase Ib dose-expansion study to assess the efficacy of CD137/FAP agonist BI 765179 plus pembrolizumab as a first-line treatment in metastatic or incurable, recurrent programmed cell death ligand-1 (PD-L1)-positive, head and neck squamous cell carcinoma (HNSCC)

Author: Radonjic, Dejan ; Puig, Marta ; Machiels, Jean-Pascal ; Hou, Jianrui ; Shroff, Rachna T.

AbstractBackground:HNSCC is the seventh most common cancer globally and is often associated with poor quality of life and a dismal prognosis. Median overall survival for advanced HNSCC with first-line standard-of-care pembrolizumab ± chemotherapy is approximately 13 months, highlighting the need for new therapies. Fibroblast activation protein (FAP)-positive fibroblasts are frequently present in the tumor stroma of HNSCC tumors, representing a potential therapeutic target. BI 765179 is a bispecific antibody that simultaneously binds to FAP and CD137, expressed on T cells, leading to local activation of tumor-specific CD137-positive T cells. In the Phase Ia dose-escalation part of the present study (NCT04958239), BI 765179 was tested in a dose-escalation trial both as monotherapy and in combination with an anti-programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors. Here we present the design of the Phase Ib part, which aims to assess the preliminary efficacy of two different doses of BI 765179 in combination with pembrolizumab in patients with metastatic or incurable recurrent HNSCC whose tumors express PD-L1.Methods:In the Phase Ib dose-expansion part, approximately 60 patients with a histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent HNSCC will be enrolled. Key inclusion criteria are no prior systemic therapy administered in the metastatic or incurable recurrent setting; primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx; at least one measurable lesion outside of the central nervous system (modified RECIST v1.1); a PD-L1-positive tumor (combined positive score ≥1, local assessment); and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Patients who have previously received CD137- and/or PDL-1-targeting agents are not eligible. Patients will be randomized 1:1 to receive either Dose 1 or Dose 2 of BI 765179 intravenously in combination with pembrolizumab. The primary endpoint is objective response (OR), defined as best overall response of confirmed complete response or confirmed partial response (RECIST v1.1). Secondary endpoints include OR (immune-related RECIST), occurrence of adverse events (AEs) and serious AEs, duration of response, progression-free survival, and overall survival.Citation Format:Rachna T. Shroff, Dejan Radonjic, Jianrui Hou, Marta Puig, Jean-Pascal Machiels. An open-label, phase Ib dose-expansion study to assess the efficacy of CD137/FAP agonist BI 765179 plus pembrolizumab as a first-line treatment in metastatic or incurable, recurrent programmed cell death ligand-1 (PD-L1)-positive, head and neck squamous cell carcinoma (HNSCC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT110.

10 Apr 2025·Journal of Clinical Oncology

HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study

Article

Author: Berz, David ; Yamamoto, Noboru ; Tu, Hai-Yan ; Sadrolhefazi, Behbood ; Yoh, Kiyotaka ; Barve, Minal ; Wu, Yi-Long ; Opdam, Frans ; Serra, Josep ; Heymach, John V. ; Schröter, Lukas ; Botilde, Yanick

PURPOSE Human epidermal growth factor receptor 2 (HER2) alterations occur in many solid cancers, including non–small cell lung cancer (NSCLC). Beamion LUNG-1 (ClinicalTrials.gov identifier: NCT04886804 ) is assessing the safety/efficacy of zongertinib (BI 1810631), a novel HER2-selective tyrosine kinase inhibitor that spares epidermal growth factor receptor, in patients with HER2-altered solid tumors. MATERIALS AND METHODSBeamion LUNG-1 is an ongoing multicenter, multicohort phase Ia/Ib trial. Phase Ia assessed zongertinib administered twice a day (15-150 mg) or once daily (60-360 mg) in pretreated patients with various tumors, including NSCLC. Primary end points were maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs); tumor response was a secondary end point.RESULTSAs of May 23, 2024, 105 patients were treated. Two DLTs occurred during the MTD evaluation period; MTD was not reached (NR). The recommended doses for expansion were 120 mg once daily and 240 mg once daily. Treatment-related adverse events (TRAEs; any/grade ≥3) occurred in 82%/10% of patients. The most common TRAEs (any/grade ≥3) included diarrhea (50%/1%), rash (16%/2%), anemia (10%/0%), decreased appetite (10%/1%), and increased alanine transaminase (10%/4%). The confirmed investigator-assessed overall response rate (ORR) across all doses/tumors was 30% (95% CI, 23 to 40); median duration of response was 12.7 months (95% CI, 6.9 to NR). In 54 patients with NSCLC, confirmed ORR was 35% (95% CI, 24 to 49). Activity was observed in patients with A775_G776insYVMA (ORR, 38%) and those who had received previous HER2-directed therapy (ORR, 28%). In patients with NSCLC receiving zongertinib once daily, median progression-free survival was 17.2 months (95% CI, 8.3 to NR).CONCLUSION Zongertinib had a manageable safety profile and demonstrated preliminary antitumor activity in patients with HER2-altered tumors, including those with HER2 -mutant NSCLC.

01 Mar 2025·Pneumologie

Zongertinib (BI 1810631) for HER2-positive Solid Tumors with Brain Metastases: Subanalysis of the Beamion LUNG-1 Trial

Author: Ruiter, G ; Zhao, Y ; Cho, B ; Sadrolhefazi, B ; Wehler, B ; Yoh, K ; Yu, Y ; Berz, D ; Planchard, D ; Wu, Y ; Opdam, F ; Yamamoto, N ; Serra, J ; Nadal, E ; Tu, H ; Lin, G ; Zugazagoitia, J ; Rohrbacher, M ; Ahn, M ; Smit, E ; Wehler, T ; Heymach, J ; Schroeter, L ; Minal, B

100 Deals associated with Boehringer Ingelheim España SA

100 Translational Medicine associated with Boehringer Ingelheim España SA

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Gliquidone ( SUR )	Diabetes Mellitus, Type 2 More	Approved
Scopolamine Butylbromide ( mAChRs )	-	Pending

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