Brightline-2

Study Name
Brightline-2
ClinicalTrials.gov Identifier (if applicable)
NCT05512377
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
Tempus (TIME) Network (US only)
State
– Please Select –
Country
United States
List additional Institutions (include address, phone number, and website)
Multiple US locations where the trial can be opened rapidly on demand bringing this trial closer to you. Please contact for additional information.
Study Contacts
Principal Investigator
Tempus (TIME) Network (US only)
P.I. Email
trials@tempus.com
Study Coordinator
N/A
Study Coordinator Email
trials@tempus.com
OVERVIEW – in layman’s terms (150 words max)
This study is open to adults with advanced cancer in the biliary tract or pancreas in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile.
Enrollment
Plan to enroll 100 subjects over approximately 2 years
Study Start Date
11/11/2022
Estimated Completion Date
11/27/2026
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • To analyze efficacy and safety of BI 907828 in patients with advanced/metastatic MDM2 amplified/TP53wt biliary tract cancer (cholangiocarcinoma, gallbladder carcinoma, ampullary cancer). To analyze quality of life, PFS, OS, duration of response
Inclusion Criteria – Patients Must:
  • Advanced/metastatic disease without approved treatment option MDM2 amplified / TP 53wt per local test
Exclusion Criteria – Patients Must NOT:
  • 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).
  • Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or efficacy endpoint assessment.
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • MDM2 amplification, TP53 wildtype
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Myelosuppression (decrease of white and red cells and platelets. Gastrointestinal side effects: nausea, diarrhea, and vomiting)