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Experimental drug BI 765883 tested in pancreatic cancer – early trial ends

NCT ID NCT06528093

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 3 times

Summary

This early study tested an experimental drug called BI 765883, alone or with chemotherapy, in 8 adults with advanced pancreatic cancer. The goal was to find a safe dose and see if it helps shrink tumors. The trial was terminated early, so results are limited.

What this could mean

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

Active substance
BI 765883 (an experimental drug) given alone or with gemcitabine and nab-paclitaxel chemotherapy
What this could lead to
If it works, this could point toward a new treatment option for advanced pancreatic cancer.
What could go wrong
This is a very early, small trial (only 8 people) that was terminated, so results are limited. The drug may not be effective or safe in larger studies.

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

8 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2025

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: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 2. Of legal adult age (according to local legislation) at screening 3. Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. 4. Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC) 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 6. Life expectancy ≥3 months in the opinion of the investigator 7. Archived tumor tissue from a tissue core biopsy (e.g. paraffin-embedded formalin-fixed tissue blocks), OR fresh tumor tissue available for retrospective biomarker analysis; in both cases, a minimum of at least two core needle biopsies (18 gauge or greater) is required. Only non-significant risk procedures per the investigator's judgment will be used to obtain any biopsies specified in this study in cases where a fresh tumor biopsy is required. 8. Patients with at least 1 target lesion that can be accurately measured per RECIST version 1.1 Further inclusion criteria apply. Exclusion Criteria: 1. Previous exposure to trial drug (BI 765883) 2. Any prior gemcitabine and/or paclitaxel therapy (for combination therapy cohorts) 3. Known hypersensitivity to the study medications or their excipients (including gemcitabine and nab-paclitaxel) 4. Any contraindications to gemcitabine or nab-paclitaxel according to the current approved local labels (combination therapy) 5. Currently enrolled in another investigational device or drug trial, or less than 28 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s) 6. Any serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease, active ulcers (gastrointestinal tract, skin), inflammatory bowel disease or bowel infection, or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the Investigator, would make the patient inappropriate for entry into the trial. 7. Prior radiotherapy or systemic therapy within 14 days prior to treatment start 8. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • CTR Eugène Marquis

    Rennes, 35042, France

  • CTR Leon Berard

    Lyon, 69373, France

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Florida Cancer Specialists-Sarasota-61670

    Sarasota, Florida, 34232, United States

  • HealthONE

    Denver, Colorado, 80218, United States

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Klinikum der Universität München AÖR

    München, 81377, Germany

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577, Japan

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitätsklinikum Hamburg, Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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