Delving into the Latest Updates on BI-891065 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BI 891065

Target

IAP

Action

inhibitors

Mechanism

Inhibitors of apoptosis (IAP) protein family inhibitors

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication-

Inactive Indication

Advanced Malignant Solid Neoplasmmetastatic non-small cell lung cancer

Originator Organization

Boehringer Ingelheim GmbH

Active Organization-

Inactive Organization

Boehringer Ingelheim GmbH

License Organization-

Drug Highest PhaseDiscontinuedPhase 1

First Approval Date-

Regulation-

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The primary objective of this trial is:
Part A
- To determine the Maximum tolerated dose (MTD) and/or the recommended dose (RD) of BI 891065 monotherapy for further development in Asian patients with advanced solid tumours
Part B
- To determine the MTD and/or the RD of BI 891065 in combination with a fixed dose of BI 754091 at 240 mg for further development in Asian patients with advanced solid tumours
The secondary objectives are:
Part A
- To document the safety and tolerability, and characterise pharmacokinetics (PK) of BI 891065 as monotherapy in Asian patients with advanced solid tumours
Part B
- To document the safety and tolerability, and characterise PK of the combination therapy of BI 891065 and BI 754091 in Asian patients with advanced solid tumours

Start Date26 Nov 2019

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT03166631

/ TerminatedPhase 1

An Open-label Phase I Dose Finding Trial With BI 891065 Alone and in Combination With BI 754091 to Characterise Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Advanced and/or Metastatic Malignancies

The main objective of the dose-escalation parts of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting toxicities (DLTs), and/or the recommended dose for further development of BI 891065 monotherapy as well as of BI 891065 in combination with BI 754091, and to evaluate its safety and tolerability by monitoring the occurrence and severity of adverse events (AEs).
Secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 891065 monotherapy as well as of BI 891065 in combination with BI 754091, and the preliminary assessment of anti-tumour activity.

Start Date08 Sep 2017

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with BI-891065

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100 Translational Medicine associated with BI-891065

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100 Patents (Medical) associated with BI-891065

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100 Deals associated with BI-891065

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	Japan	Boehringer Ingelheim GmbH	26 Nov 2019
metastatic non-small cell lung cancer	Phase 1	United States	Boehringer Ingelheim GmbH	08 Sep 2017