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A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

NCT07607678 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-29

No results posted yet for this study

Summary

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.

Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.

Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

Conditions

  • Advanced Solid Cancer
  • Metastatic Solid Cancer

Interventions

DRUG

BI 3819026

BI 3819026

DRUG

Ezabenlimab (BI 754091)

Ezabenlimab (BI 754091)

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-06-05
Completion
2030-10-15
FDA Drug
Yes

Countries

  • United States
  • Japan
  • Spain

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 NCT07607678 on ClinicalTrials.gov