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
| Condition | Pancreatic Ductal Adenocarcinoma |
|---|---|
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Status | Terminated |
| Enrollment | 8 participants |
| Interventions | BI 765883, Gemcitabine, Nab-paclitaxel |
| Start date | Oct 16, 2024 |
| Completion date | Mar 19, 2025 |
| Results posted | Jul 15, 2026 |
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.
Occurrence of Dose-Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period for the Determination of the Maximum Tolerated Dose (MTD)
| BI 765883 0.4 mg/kg, Monotherapy | 0 Participants |
|---|---|
| BI 765883 1.3 mg/kg, Monotherapy | 0 Participants |
| BI 765883 0.4 mg/kg + Chemotherapy | 3 Participants |
Open in BENITIONS View on ClinicalTrials.gov
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