臨床研究等提出・公開システム

A first-in-human open label Phase Ia/Ib, multicenter/multiregional, dose escalation study of BI 765883 administered 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

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

Nakahara Asuka

Nippon Boehringer Ingelheim Co., Ltd

2-1-1 Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Katakabe Tetstuya

Nippon Boehringer Ingelheim Co., Ltd

2-1-1 Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Sept. 27, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC)
-Eastern Cooperative Oncology Group (ECOG) performance status 0 to1
-Life expectancy more than 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.

Both

metastatic pancreatic ductal adenocarcinoma

BI 765883 in monotherapy or in combination with gemcitabine and nab-paclitaxel.

Occurrence of DLTs in the MTD evaluation period for the determination of the MTD

+81-4-7133-1111

Aug. 28, 2024

No

US/Belgium/France/Germany/Spain