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Brightline-2: A Phase IIa/IIb, open-label, single-arm, multi-centre trial of BI 907828 for treatment of patients with locally advanced / metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours (Brightline-2)

A study to test whether BI 907828 helps people with cancer in the biliary tract or pancreas (Brightline-2)

Ogawa Shintaro

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku

medchiken.jp@boehringer-ingelheim.com

Yamagami Tomohiro

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Nov. 25, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Diagnosis of a solid tumour which meets the criteria for an open trial cohort:
-Cohort 1 (biliary tract adenocarcinoma):
Locally advanced or metastatic biliary tract adenocarcinoma (intra- and extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary cancer). Patient must have received appropriate prior standard of care therapy; or (in the opinion of the investigator) patient is unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
Cohort 2-4 (pancreatic ductal adenocarcinoma, lung adenocarcinoma, urothelial bladder cancer):
Locally advanced or metastatic pancreatic ductal adenocarcinoma/lung adenocarcinoma/urothelial bladder
cancer. Patient must have received appropriate prior standard of care therapy.

Written pathology report / molecular profiling report indicating MDM2 amplification (copy number >=8) and TLocally advanced or metastatic pancreatic ductal adenocarcinoma. Patient must have received appropriate prior standard of care therapy.
P53 wild-type status.
Archival tissue (formalin fixed paraffin embedded [FFPE] tumour blocks or slides) or a fresh tumour biopsy must be provided for retrospective confirmation of MDM2 amplification and TP53 status.
Presence of at least 1 measurable target lesion according to RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate organ function.

Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
Active bleeding, significant risk of haemorrhage (e.g. previous severe gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current bleeding disorder (e.g. haemophilia, von Willebrand disease).
Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of trial treatment or planned within 6 months after screening (e.g. hip replacement).
Clinically significant previous or concomitant malignancies in the opinion of the investigator affecting the efficacy and/or outcome of the trial.
Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or efficacy endpoint assessment.

Both

Biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours

Single dose on Day 1 every 21 days

Objective response (OR) based on central independent review. OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

DOR based on central independent review. DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed objective response.
PFS based on central independent review. PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
OS, defined as the time from treatment start until death from any cause.
Disease control (DC) based on central independent review. DC is defined as a best overall response of CR, PR, or stable disease (SD) where best overall response is defined according to RECIST version 1.1.
Occurrence of treatment-emergent adverse events (AEs) during the on-treatment period.
Occurrence of treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period.
Endpoints reflecting Patient Reported Outcomes (PRO) will be assessed with the following PRO measures (PROMs), for Cohort 1 only:
- Change from baseline in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 fatigue domain score
- Change from baseline in EORTC QLQ-C30 role functioning domain score
- Change from baseline in EORTC QLQ-BIL21 tiredness domain score

Nov. 02, 2022

Nov. 02, 2022

Nov. 02, 2022

No

USA/Spain/Korea/Singapore