NCT03166631

A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neoplasms
• Neoplasm Metastasis
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	BI 891065	Part A, Part B
DRUG	BI 754091	Part B

Timeline

• Start date: 2017-09-08
• Primary completion: 2020-09-15
• Completion: 2020-10-28
• First posted: 2017-05-25
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study