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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
BI 765883
gemcitabine
nab-paclitaxel
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
...and 7 more locations
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
phase Ia
Time frame: Up to 28 days (2 treatment cycles)
Confirmed objective response (OR)
phase Ib
Time frame: Up to 350 days (25 treatment cycles)
Objective response (OR)
phase Ia
Time frame: Up to 350 days (25 treatment cycles)
Recommended dose for expansion (RDE) for BI 765883 in combination with gemcitabine and nab-paclitaxel
phase Ia
Time frame: 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
Time frame: Up to 350 days (25 treatment cycles)
Maximum measured concentration of the analyte in serum (Cmax)
phase Ia and phase Ib
Time frame: Up to 350 days (25 treatment cycles)
Area under the serum concentration time curve of the analyte (AUC0-t)
phase Ia and phase Ib
Time frame: Up to 350 days (25 treatment cycles)
Progression-free survival (PFS)
phase Ib
Time frame: Up to 350 days (25 treatment cycles)
Duration of response (DOR)
phase Ib
Time frame: Up to 350 days (25 treatment cycles)
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