A Study To Test Different Doses Of BI 765049 In People With Advanced Cancer Of The Colon, Rectum, Stomach, Or Pancreas

Study Overview

A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas

This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists. The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment and can tolerate it. During this time, participants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within 1 week after the first treatment with the intended dose.

N/A

Colorectal Carcinoma
Gastric Carcinoma
Pancreatic Ductal Adenocarcinoma

DRUG: BI 765049

1454-0015
2024-519301-36-00 (CTIS Identifier) (CTIS: )
U1111-1316-8363 (REGISTRY Identifier) (REGISTRY: WHO - International Clinical Trials Registry Platform (ICTRP))

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 2025-03-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-04
First Submitted that Met QC Criteria 2025-03-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-05
First Posted (ACTUAL) 2025-03-19	Results First Posted N/A	Last Verified 2025-08

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: Part 1 (Administration Regimen A)	DRUG: BI 765049 BI 765049
EXPERIMENTAL: Part 2 (Administration Regimen B)	DRUG: BI 765049 BI 765049

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Part 1 (Administration Regimen A)

DRUG: BI 765049

BI 765049

EXPERIMENTAL: Part 2 (Administration Regimen B)

DRUG: BI 765049

BI 765049

Primary Outcome Measures	Measure Description	Time Frame
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period		up to 36 months

Secondary Outcome Measures	Measure Description	Time Frame
Objective response (OR)	OR defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST) 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review	up to 36 months
Occurrence of DLTs and adverse events during the entire treatment period		up to 36 months
Maximum measured concentration (Cmax) of BI 765049 after first administration		up to 4 days
Maximum measured concentration (Cmax) of BI 765049 after multiple administrations		up to 20 days
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration		up to 4 days
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations		up to 20 days

Contacts and Locations

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

Study Contact

Name: Boehringer Ingelheim

Phone Number: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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 informed consent form (ICF)2/main ICF 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 and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature on the ICFs (ICF1/screening ICF and ICF2/main ICF).
In US: Patients with a histologically or cytologically confirmed diagnosis of colorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductal adenocarcinoma (PDAC).
In Europe: Patients with a histologically or cytologically confirmed diagnosis of CRC.
Patients with advanced, unresectable, and/or metastatic disease. 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).
Previous or concomitant malignancies other than the one treated in this trial within the last 5 years except:

Effectively treated non-melanoma skin cancers
Effectively treated carcinoma in situ of the cervix
Effectively treated ductal carcinoma in situ
Other effectively treated malignancy that is considered cured by local treatment"
Patient with known leptomeningeal disease or spinal cord compression due to disease.
Patient requiring anticoagulant treatment which cannot be safely interrupted, if medically needed based on the opinion of the Investigator.

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record