Back to search results

A Study of BI 765049 for Advanced Colon, Rectum, Stomach, or Pancreas Cancer

This study is for adults with advanced cancer of the colon, rectum, stomach, or pancreas that cannot be removed by surgery or has spread. You may be able to join if previous treatments haven't worked or there are no other options. The study is testing different doses of a medicine called BI 765049. Researchers want to find the highest dose that people can tolerate and the best way to give it. BI 765049 may help your immune system fight the cancer. You would receive BI 765049 at least once every three weeks and can continue as long as it helps and you tolerate it. The main goal is to see how many participants experience side effects that limit the dose.

Study design
This is an interventional study with a planned enrollment of 135 participants. It is testing different doses of BI 765049.
What's involved
You would receive BI 765049 at least once every 3 weeks. You may continue treatment as long as you benefit and can tolerate it.
Compensation
Not stated in the trial record.
Follow-up
The occurrence of dose-limiting toxicities will be measured for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06882746

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Boehringer Ingelheim
~135 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BI 765049

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Measured over up to 36 months

Conditions

Colorectal Carcinoma
Gastric Carcinoma
Pancreatic Ductal Adenocarcinoma

Explore related trials

Colorectal CarcinomaGastric CarcinomaPancreatic Ductal AdenocarcinomaSolid Neoplasm

Where it's being run

6 sites across 6 states
California1
Connecticut1
Georgia1
New Jersey1
Germany1
Spain1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

For all patients, signed and dated informed consent form (ICF)2/main ICF 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.

Exclusion

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.

What this trial measures

  • Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation periodup to 36 months