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New drug aims to boost immune system against tough cancers

NCT ID NCT06882746

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early-phase trial tests an experimental drug called BI 765049 in adults with advanced colorectal, stomach, or pancreatic cancer that cannot be removed by surgery or has spread. The main goal is to find the highest dose people can tolerate and to see if the drug helps the immune system fight the cancer. About 135 participants will receive the drug at least every three weeks and be closely monitored for side effects and tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 765049 (an experimental immunotherapy drug given by injection or infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced colorectal, stomach, or pancreatic cancer who have run out of standard options.
What could go wrong
This is a very early (Phase 1) trial with only 135 participants, so the drug may not work or may cause severe side effects. The cancers studied are hard to treat, and success is far from guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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. * Patients with advanced, unresectable, and/or metastatic disease. Further inclusion criteria apply. Exclusion criteria: * 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. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma colorectal neoplasm gastric carcinoma gastric neoplasm pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal carcinoma Gastric carcinoma Pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Technische Universität Dresden

    Dresden, 01307, Germany

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.