BENITIONSClinical Trial Intelligence

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

1상 조기 종료 NCT06528093

대상 질환Pancreatic Ductal Adenocarcinoma
임상 단계1상
스폰서Boehringer Ingelheim
상태조기 종료
참여자 수8 명
중재(약물)BI 765883, Gemcitabine, Nab-paclitaxel
시작일2024년 10월 16일
완료일2025년 3월 19일
결과 공개일2026년 7월 15일

요약

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)

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. · Participants

BI 765883 0.4 mg/kg, Monotherapy0 Participants
BI 765883 1.3 mg/kg, Monotherapy0 Participants
BI 765883 0.4 mg/kg + Chemotherapy3 Participants

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