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A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer

NCT03972150 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-10-06

Study results available
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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

Conditions

  • Neoplasms

Interventions

DRUG

BI 836880

Solution for infusion

DRUG

BI 754091

Solution for infusion

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2020-10-27
Completion
2022-03-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972150 on ClinicalTrials.gov