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This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer

NCT03433898 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-12-19

Study results available
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Summary

The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are to investigate the following items in advanced solid tumours:

* Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy.
* Maximum tolerated dose (MTD) and/or recommended dose (RD) of BI 754091 monotherapy.

The main objectives of the Combination dose-finding part (Part II) of the trial are to investigate the following items in advanced solid tumours:

* Safety, tolerability, and PK of the combination treatment of BI 754091 and BI 754111.
* MTD and/or RD of the combination treatment of BI 754091 and BI 754111.

The main objectives of the expansion part (Part III) of the trial are:

* To further investigate the safety, tolerability, and PK of the RD of BI 754091 and BI 754111 combination in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or non-small cell lung cancer (NSCLC)
* To explore the efficacy of the RD of the combination of BI 754091 and BI 754111 in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or NSCLC

Conditions

  • Neoplasms

Interventions

DRUG

Ezabenlimab

Solution for infusion

DRUG

BI 754111

Solution for infusion

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2023-07-20
Completion
2023-07-20
FDA Drug
Yes

Countries

  • Japan
  • South Korea
  • Taiwan

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 NCT03433898 on ClinicalTrials.gov