CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
BI 836880 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03972150
NCT03972150Phase 1Completed
CompareCT.gov

An Open Label, Phase I Study of BI 836880 Monotherapy and Combination Therapy of BI 836880 and BI 754091 in Japanese Patients With Advanced Solid Tumours

Boehringer Ingelheim·interventional·Posted Jun 3, 2019·Updated Oct 6, 2025

In Brief

A Phase 1 clinical trial evaluating BI 836880 and BI 754091 for Neoplasms. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

The primary objective of this trial is: Part I * To determine Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BI 836880 monotherapy Part II * To determine MTD and/or RP2D of the combination therapy of BI 836880 and BI 754091 The secondary objectives are: Part I * To document the safety and tolerability, and characterise pharmacokinetics (PK) of BI 836880 as monotherapy Part II * To document the safety and tolerability, and characterise PK of the combination therapy of BI 836880 and BI 754091

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJun 3, 2019
Enrollment StartJun 12, 2019
Primary CompletionOct 27, 2020
Study CompletionMar 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.1 years ago

Interventions

BI 836880drug

Solution for infusion

BI 754091drug

Solution for infusion