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

NCT06528093 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: 1505-00012023-508998-85-00U1111-1300-7624
• Study Type: interventional
• Target: 8
• Locations: 6 countries
• Sites: 17

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Objective response (OR)

  Up to 350 days (25 treatment cycles)

• Recommended dose for expansion (RDE) for BI 765883 in combination with gemcitabine and nab-paclitaxel

  Up to 28 days (2 treatment cycles)

• Frequency and severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE)

  Up to 350 days (25 treatment cycles)

• Maximum measured concentration of the analyte in serum (Cmax)

  Up to 350 days (25 treatment cycles)

• Area under the serum concentration time curve of the analyte (AUC0-t)

  Up to 350 days (25 treatment cycles)

Study Arms (3)

BI 765883 escalation arm

EXPERIMENTAL

phase Ia

Drug: BI 765883

BI 765883 + gemcitabine + nab-paclitaxel escalation arm

EXPERIMENTAL

phase Ia

Drug: BI 765883; Drug: gemcitabine; Drug: nab-paclitaxel

BI 765883 + gemcitabine + nab-paclitaxel expansion arm

EXPERIMENTAL

phase Ib

Drug: BI 765883; Drug: gemcitabine; Drug: nab-paclitaxel

Interventions

BI 765883 DRUG

BI 765883

BI 765883 + gemcitabine + nab-paclitaxel escalation arm; BI 765883 + gemcitabine + nab-paclitaxel expansion arm; BI 765883 escalation arm

gemcitabine DRUG

gemcitabine

BI 765883 + gemcitabine + nab-paclitaxel escalation arm; BI 765883 + gemcitabine + nab-paclitaxel expansion arm

nab-paclitaxel DRUG

nab-paclitaxel

BI 765883 + gemcitabine + nab-paclitaxel escalation arm; BI 765883 + gemcitabine + nab-paclitaxel expansion arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
• Of legal adult age (according to local legislation) at screening
• 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.
• Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Life expectancy ≥3 months in the opinion of the investigator
• 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.

You may not qualify if:

• Previous exposure to trial drug (BI 765883)
• Any prior gemcitabine and/or paclitaxel therapy (for combination therapy cohorts)
• Known hypersensitivity to the study medications or their excipients (including gemcitabine and nab-paclitaxel)
• Any contraindications to gemcitabine or nab-paclitaxel according to the current approved local labels (combination therapy)
• 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)
• 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.
• Prior radiotherapy or systemic therapy within 14 days prior to treatment start

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (17)

HealthONE

Denver, Colorado, 80218, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Florida Cancer Specialists-Sarasota-61670

Sarasota, Florida, 34232, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CTR Leon Berard

Lyon, 69373, France

Location

CTR Eugène Marquis

Rennes, 35042, France

Location

INS Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Hamburg, Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Klinikum der Universität München AÖR

München, 81377, Germany

Location

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

Location

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045, Japan

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Related Links

• Related Info

MeSH Terms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: October 16, 2024
• Primary Completion: March 19, 2025
• Study Completion: June 19, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

FR (3); JP (2); BE (2); ES (2); US (5); DE (3)