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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT06528093•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Locations (17)

HealthONE

Denver, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists-Sarasota-61670

Sarasota, Florida, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

CTR Leon Berard

Lyon, France

CTR Eugène Marquis

Rennes, France

INS Gustave Roussy

Villejuif, France

Key Dates

Start Date

October 16, 2024

Primary Completion Date

March 19, 2025

Completion Date

June 19, 2025

Last Updated

February 3, 2026

Enrollment

ACTUAL participants

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

BI 765883

DRUG

gemcitabine

DRUG

nab-paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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