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
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT06528093
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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.
- Patients with at least 1 target lesion that can be accurately measured per RECIST version 1.1 Further inclusion criteria apply.
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BI 765883 + gemcitabine + nab-paclitaxel escalation arm BI 765883 phase Ia BI 765883 + gemcitabine + nab-paclitaxel escalation arm gemcitabine phase Ia BI 765883 + gemcitabine + nab-paclitaxel expansion arm gemcitabine phase Ib BI 765883 escalation arm BI 765883 phase Ia BI 765883 + gemcitabine + nab-paclitaxel escalation arm nab-paclitaxel phase Ia BI 765883 + gemcitabine + nab-paclitaxel expansion arm nab-paclitaxel phase Ib BI 765883 + gemcitabine + nab-paclitaxel expansion arm BI 765883 phase Ib
- Primary Outcome Measures
Name Time Method Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period Up to 28 days (2 treatment cycles) phase Ia
Confirmed objective response (OR) Up to 350 days (25 treatment cycles) phase Ib
- Secondary Outcome Measures
Name Time Method Objective response (OR) Up to 350 days (25 treatment cycles) phase Ia
Recommended dose for expansion (RDE) for BI 765883 in combination with gemcitabine and nab-paclitaxel Up to 28 days (2 treatment cycles) phase Ia
Frequency and severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) Up to 350 days (25 treatment cycles) phase Ia and phase Ib
Maximum measured concentration of the analyte in serum (Cmax) Up to 350 days (25 treatment cycles) phase Ia and phase Ib
Area under the serum concentration time curve of the analyte (AUC0-t) Up to 350 days (25 treatment cycles) phase Ia and phase Ib
Progression-free survival (PFS) Up to 350 days (25 treatment cycles) phase Ib
Duration of response (DOR) Up to 350 days (25 treatment cycles) phase Ib
Trial Locations
- Locations (18)
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
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CTR Leon Berard
🇫🇷Lyon, France
CTR Eugène Marquis
🇫🇷Rennes, France
INS Gustave Roussy
🇫🇷Villejuif, France
Universitätsklinikum Hamburg, Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Klinikum der Universität München AÖR
🇩🇪München, Germany
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain