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 Results 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 (1)

• Occurrence of Dose-Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period for the Determination of the Maximum Tolerated Dose (MTD)

  All Dose-Limiting Toxicities (DLTs) were agreed upon by the Dose-Escalation Committee (DEC) after review of the data from each cohort. Only Dose-Limiting Toxicities (DLTs) occurring in the first 2 cycles were considered necessary for dose-escalation decisions made by the Dose-Escalation Committee (DEC). Dose-Limiting Toxicities (DLTs) observed during the Maximum Tolerated Dose (MTD) evaluation period were considered for Maximum Tolerated Dose (MTD) determination. The MTD evaluation period was defined as the first two treatment cycles; i.e. from Cycle 1 Day 1 (C1D1) up to and including the day before C3D1, or to the end of the REP in case of discontinuation before the start of C3.

  The MTD evaluation period corresponds to the first two treatment cycles (28 days), with extension up to 35 days in cases of early discontinuation, based on the residual effect period.

Secondary Outcomes (5)

• Best Overall Response as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.

• Disease Control as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.

• Objective Response (OR) as Assessed by the Investigator Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.

• Maximum Measured Concentration of BI 765883 in Serum (Cmax)

  Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.

• Area Under the Concentration-Time Curve of BI 765883 From Time 0 to 336 Hours (AUC₀-336)

  Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.

Study Arms (3)

BI 765883 0.4 mg/kg, monotherapy

EXPERIMENTAL

Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.

Drug: BI 765883

BI 765883 1.3 mg/kg, monotherapy

EXPERIMENTAL

Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.

Drug: BI 765883

BI 765883 0.4 mg/kg + chemotherapy

EXPERIMENTAL

Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.

Drug: BI 765883; Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

BI 765883 DRUG

Participants received BI 765883 at doses of 0.4 mg/kg or 1.3 mg/kg, administered intravenously.

BI 765883 0.4 mg/kg + chemotherapy; BI 765883 0.4 mg/kg, monotherapy; BI 765883 1.3 mg/kg, monotherapy

Gemcitabine DRUG

Participants received gemcitabine at a dose of 1000 mg/m², administered intravenously

BI 765883 0.4 mg/kg + chemotherapy

Nab-paclitaxel DRUG

Participants received Nab-paclitaxel at a dose of 125 mg/m², administered intravenously

BI 765883 0.4 mg/kg + chemotherapy

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

Institut 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

Limitations and Caveats

This trial was prematurely discontinued due to an emerging unacceptable safety profile.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

018002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: July 15, 2026
• Results First Posted: July 15, 2026

Record last verified: 2026-06

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)