A Study Evaluating Different Doses Of BI 765049 When Given Alone And When Given With Ezabenlimab To Patients With Advanced Solid Tumors Expressing The Protein B7-H6 On The Cell Surface

Study Overview

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface

This study is open to adults with advanced solid tumors whose previous cancer treatment was not successful. People can participate if their tumor has the B7-H6 marker or if they have colorectal cancer. The study tests 2 medicines called BI 765049 and ezabenlimab (BI 754091). Both medicines may help the immune system fight cancer. The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with ezabenlimab the participants can tolerate. In this study, BI 765049 is given to people for the first time. Participants can stay in the study for up to 3 years, if they benefit from treatment and can tolerate it. During this time, they get BI 765049 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. The doctors also regularly monitor the size of the tumor.

N/A

Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Head and Neck Neoplasms, Gastrointestinal Neoplasms

DRUG: BI 765049
DRUG: ezabenlimab

1454-0001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-02-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-27
First Submitted that Met QC Criteria 2021-02-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-28
First Posted (ACTUAL) 2021-02-12	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BI 765049 single treatment group BI 765049	DRUG: BI 765049 BI 765049
EXPERIMENTAL: BI 765049 + ezabenlimab combination treatment group BI 765049 + ezabenlimab	DRUG: BI 765049 BI 765049 DRUG: ezabenlimab ezabenlimab

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: BI 765049 single treatment group

BI 765049

DRUG: BI 765049

BI 765049

EXPERIMENTAL: BI 765049 + ezabenlimab combination treatment group

BI 765049 + ezabenlimab

DRUG: BI 765049

BI 765049

DRUG: ezabenlimab

ezabenlimab

Primary Outcome Measures	Measure Description	Time Frame
Maximum tolerated dose (MTD) in any studied regimen	defined as the highest dose with less than 25 percent (%) risk of the true dose limiting toxicity (DLT) rate being equal to or above 33 percent (%) during the MTD evaluation period	Up to 3 weeks
Number of patients with dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period		Up to 3 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Maximum measured concentration of BI 765049 (Cmax)		Up to 36 months
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ)		Up to 36 months
Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients with measurable disease		Up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Signed and dated, written informed consent form (ICF) (ICF1 for B7-H6 testing for all patients except those with advanced or metastatic colorectal cancer (CRC); and ICF2 for all patients) describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
Patient must be ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).
Patients with a histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic colorectal carcinoma (CRC), non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), head and neck squamous cell carcinoma (HNSCC), gastric carcinoma, and pancreatic carcinoma. At least 1 patient in each back-fill slot must be a non-CRC patient (i.e., NSCLC, HCC, HNSCC, gastric carcinoma, or pancreatic carcinoma).
Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, or with a tumor for which no conventional treatment exists.
All patients must agree to the collection of tumor samples (as slides from archival diagnostic samples or fresh tumor biopsies) for confirmation of B7-H6 expression either at Screening visit 02 (for CRC patients) or Screening visit 01 (for all other patients). To qualify for a back-fill slot or recommended dose expansion (RDE) cohort, the patient must agree to the collection of mandatory pre-treatment and on-treatment fresh tumor biopsies.
Patient diagnosed with advanced or metastatic CRC or patient with confirmed B7-H6 expression on tumor tissue sample (archived or fresh tumor biopsy) based on central pathology review.
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patient must have at least one evaluable target lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 separate from any lesion(s) identified for tumor biopsy. Tumor lesions that have been irradiated at least ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions only in the absence of measurable lesions that have not been irradiated.
Further inclusion criteria apply

Patient with a history of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's and/or Medical Monitor's assessment).
Patient with a history of a previous or concomitant malignancies. Patient with a malignancy considered effectively treated and cured by 'local treatment' within the last 2 years and that is distinct from the one treated in this trial will be allowed.
Patient with known leptomeningeal disease or spinal cord compression due to disease.
Patient requiring anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g., biopsy) based on the opinion of the Investigator.
History of systemic antimicrobials required for an infection within 7 days of first dose BI 765049.
Patient with any of the following laboratory evidence of hepatitis virus infection. Test results obtained in routine diagnostics are acceptable for screening if done within 14 days before the ICF2 date:

Positive results of hepatitis B surface (HBs) antigen
Presence of hepatitis B core (HBc) antibody together with hepatitis B virus (HBV)-DNA
Presence of hepatitis C-RNA
Patient with known human immunodeficiency virus (HIV) infection.
Patient previous treatment history:

Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first administration of BI 765049.
Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration of BI 765049.
Further exclusion criteria apply

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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