A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy

Last updated: September 29, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Terminated

Phase

1

Condition

Adenocarcinoma

Pancreatic Cancer

Pancreatic Disorders

Treatment

nab-paclitaxel

gemcitabine

BI 765883

Clinical Study ID

NCT06528093
1505-0001
U1111-1300-7624
2023-508998-85-00
  • Ages > 18
  • All Genders

Study Summary

This study is open to adults with advanced pancreatic cancer for whom previous treatment was not successful or no treatment exists.

The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with chemotherapy. Another purpose is to check whether BI 765883 helps people with advanced pancreatic cancer. In this study, BI 765883 is given to humans for the first time.

Participants receive either BI 765883 alone or BI 765883 in combination with chemotherapy. Participants can stay in the study as long as they benefit from treatment and can tolerate it. At study visits, doctors collect information on any health problems of the participants and check the severity of participants' cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed and dated written informed consent in accordance with ICH-GCP and locallegislation 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 tofather a child must be willing and able to use highly effective methods of birthcontrol per ICH M3 (R2) that result in a low failure rate of less than 1% per yearwhen 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-embeddedformalin-fixed tissue blocks), OR fresh tumor tissue available for retrospectivebiomarker 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 theinvestigator's judgment will be used to obtain any biopsies specified in this studyin cases where a fresh tumor biopsy is required.

  8. Patients with at least 1 target lesion that can be accurately measured per RECISTversion 1.1 Further inclusion criteria apply.

Exclusion

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 (includinggemcitabine and nab-paclitaxel)

  4. Any contraindications to gemcitabine or nab-paclitaxel according to the currentapproved local labels (combination therapy)

  5. Currently enrolled in another investigational device or drug trial, or less than 28days since ending another investigational device or drug trial(s) or receiving otherinvestigational treatment(s)

  6. Any serious concomitant disease or medical condition affecting compliance with trialrequirements or which are considered relevant for the evaluation of the efficacy orsafety of the trial drug, such as neurologic, psychiatric, infectious disease,active ulcers (gastrointestinal tract, skin), inflammatory bowel disease or bowelinfection, or laboratory abnormality that may increase the risk associated withtrial participation or trial drug administration, and in the judgment of theInvestigator, 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 uncontrolledhypertension, congestive heart failure NYHA classification of ≥III or IV, unstableangina or poorly controlled arrhythmia which are considered as clinically relevantby the Investigator Further exclusion criteria apply.

Study Design

Total Participants: 8
Treatment Group(s): 3
Primary Treatment: nab-paclitaxel
Phase: 1
Study Start date:
October 16, 2024
Estimated Completion Date:
June 19, 2025

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • CTR Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • CTR Leon Berard

    Lyon 2996944, 69373
    France

    Site Not Available

  • CTR Eugène Marquis

    Rennes, 35042
    France

    Site Not Available

  • CTR Eugène Marquis

    Rennes 2983990, 35042
    France

    Site Not Available

  • INS Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • INS Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Universitätsklinikum Hamburg, Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg, Eppendorf

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg 2907911, 69120
    Germany

    Site Not Available

  • Klinikum der Universität München AÖR

    München, 81377
    Germany

    Site Not Available

  • Klinikum der Universität München AÖR

    München 2867711, 81377
    Germany

    Site Not Available

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Vall d'Hebron-Barcelona-47683

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • HealthONE

    Denver, Colorado 80218
    United States

    Site Not Available

  • HealthONE

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specialists-Sarasota-61670

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specialists-Sarasota-61670

    Sarasota 4172131, Florida 4155751 34232
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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