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

A First-in-human Open Label Phase Ia/Ib, Multicenter/Multiregional, Dose Escalation Study of BI 765883 Administered Intravenously as Monotherapy and in Combination With Gemcitabine and Nab-paclitaxel in Unselected Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) or Patients With PDAC Who Have Relapsed After Post-surgery Adjuvant Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: BI 765883; Drug: gemcitabine; Drug: nab-paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Leuven, Belgium, 3000
    • UZ Leuven
• France
  • Lyon, France, 69373
    • CTR Leon Berard
  • Rennes, France, 35042
    • CTR Eugène Marquis
  • Villejuif, France, 94805
    • INS Gustave Roussy
• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg, Eppendorf
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • München, Germany, 81377
    • Klinikum der Universität München AÖR
• Japan
  • Chiba, Kashiwa, Japan, 277-8577
    • National Cancer Center Hospital East
  • Tokyo, Chuo-ku, Japan, 104-0045
    • National Cancer Center Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • HealthONE
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Cancer Center
  • Florida
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists-Sarasota-61670
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 765883 escalation arm; phase Ia	Drug: BI 765883; BI 765883
Experimental: BI 765883 + gemcitabine + nab-paclitaxel escalation arm; phase Ia	Drug: BI 765883; BI 765883; Drug: gemcitabine; gemcitabine; Drug: nab-paclitaxel; nab-paclitaxel
Experimental: BI 765883 + gemcitabine + nab-paclitaxel expansion arm; phase Ib	Drug: BI 765883; BI 765883; Drug: gemcitabine; gemcitabine; Drug: nab-paclitaxel; nab-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period	phase Ia	Up to 28 days (2 treatment cycles)
Confirmed objective response (OR)	phase Ib	Up to 350 days (25 treatment cycles)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response (OR)	phase Ia	Up to 350 days (25 treatment cycles)
Recommended dose for expansion (RDE) for BI 765883 in combination with gemcitabine and nab-paclitaxel	phase Ia	Up to 28 days (2 treatment cycles)
Frequency and severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE)	phase Ia and phase Ib	Up to 350 days (25 treatment cycles)
Maximum measured concentration of the analyte in serum (Cmax)	phase Ia and phase Ib	Up to 350 days (25 treatment cycles)
Area under the serum concentration time curve of the analyte (AUC0-t)	phase Ia and phase Ib	Up to 350 days (25 treatment cycles)
Progression-free survival (PFS)	phase Ib	Up to 350 days (25 treatment cycles)
Duration of response (DOR)	phase Ib	Up to 350 days (25 treatment cycles)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: 1505-0001; 2023-508998-85-00 (Registry Identifier: CTIS); U1111-1300-7624 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No